Table 1 Outcome Variables - Baylor University | A ...



Incomplete Protocol Example ExerciseInstructions:Print out the Protocol Element Checklist.Read the following Protocol Example.As you read the protocol think about the checklist and identify areas for improvement (there will be plenty). Complete this exercise after completing the 6 pre-workshop classes and prior to the residence phase of the course.Plan to discuss your finding during the MLH Practical Exercise #1 on 2 May.Note that this was LTC Cole’s first protocol (back as a young CPT!). The format is old but still appropriate as an example since the protocol was intentionally altered to make it an incomplete example. You should find areas for improvement. Good Luck!!BAMC/WHMCPROTOCOL FOR CLINICAL INVESTIGATIONS -- HUMAN1.0 Title: Effectiveness of a pedometer and interactive website in motivating Service Members and DoD beneficiaries to reach a 10,000 steps per day goal2.0 Principal Investigator (PI):CPT Renee E. Cole, PhD, RD, LD, U.S. Army Medical Specialist Corps (Army Dietitian)Chief, Outpatient Nutrition, Nutrition Care Division, Brooke Army Medical Center3851 Roger Brooke DriveFort Sam Houston, Texas 78234renee.cole@amedd.army.milPhone: (210) XXX-XXXX2.1 Associate Investigator: 2LT Yu Knomee, BS, U.S. Army Medical Specialist Corps (Army Dietitian)Graduate Student, Army Dietetic Internshipyu.knowmee@us.army.milPhone: (210) XXX-XXXX2.2 Other Investigators:Ida K. Areboutit, BA, FAACVPR, GS-12, DAC (Director of Cardiopulmonary Rehabilitation)Cardiology Clinic, Dept of Medicine, HSHE-MDCBrooke Army Medical Center3851 Roger Brooke DriveFort Sam Houston, Texas 78234Ida.k.areboutit@amedd.army.milPhone: (210) XXX-XXXXWah T. Supp, BS, Contractor, Cardiac Rehabilitation TherapistCardiology Clinic, Dept of Medicine, HSHE-MDCBrooke Army Medical Center3851 Roger Brooke DriveFort Sam Houston, Texas 78234wah.t.supp@amedd.army.milPhone: (210) XXX-XXXX3.0 Location: Brooke Army Medical Center, Fort Sam Houston, Texas 782344.0 Research Plan4.1 Purpose: The objective is to evaluate the effectiveness of the Digi-Walker SW200 pedometer (a device to count steps) with corresponding New Lifestyles interactive website in increasing physical activity in overweight or obese Soldiers and Department of Defense (DoD) beneficiaries. This study is designed to provide pedometers and access to an interactive website to increase the motivation of participants in doubling their usual steps taken per day with an ultimate goal of reaching 10,000 steps per day within 3 months. The six-month goal is to modify behaviors to consistently incorporate additional non-regimented physical activity (increased steps per day) into daily habits with the anticipation of contributing to improved anthropometric and clinical measurements. The program will focus on benefits of increasing steps per day, goal setting in order to reach 10,000 steps per day, suggestions and feedback through the interactive website and investigators, periodic anthropometric and clinical measurements, and techniques to improve self-efficacy. 4.2 Hypotheses/Research Questions:Hypothesis:Use of a pedometer with interactive website will motivate participants to significantly increase their steps per day. Reaching a goal of 10,000 steps per day in 12 weeks will lead to a decrease in waist circumference and body mass index (BMI).Daily step counts will regress slightly once the study is complete (12 weeks); however, the six-month data collection will depict no statistical decline in step-count progress.Research Question:Will pedometer use lead to 10,000 steps per day?Will increased activity improve health?Will participant steps per day goal be maintained at the six month data collection?4.3 Significance:Approximately 64% of all Americans are overweight and approximately 30% are obese ADDIN EN.CITE <EndNote><Cite><Year>2005</Year><RecNum>39</RecNum><record><rec-number>39</rec-number><ref-type name="Report">27</ref-type><contributors></contributors><titles><title>Overweight in the Military: Issue Brief: Health Care Survey of DoD Beneficiaries</title><secondary-title>Health Program Analysis and Evaluation Directorate</secondary-title></titles><pages>3-4</pages><dates><year>2005</year></dates><urls><related-urls><url>tricare.mil/survey/hcsurvey/issue-briefCYO5Q1.pdf</url></related-urls></urls></record></Cite><Cite><Author>Kress</Author><Year>2005</Year><RecNum>36</RecNum><record><rec-number>36</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kress, A. M.</author><author>Hartzel, M. C.</author><author>Peterson, M. R.</author></authors></contributors><auth-address>Center for Health Care Management Studies, Office of the Assistant Secretary of Defense, Health Affairs (OASD (HA)), TRICARE Management Activity (TMA), 5111 Leesburg Pike, Suite 810, Falls Church, VA 22041-3206, USA. amii.kress@tma.osd.mil</auth-address><titles><title>Burden of disease associated with overweight and obesity among U.S. military retirees and their dependents, aged 38-64, 2003</title><secondary-title>Prev Med</secondary-title><alt-title>Preventive medicine</alt-title></titles><pages>63-9</pages><volume>41</volume><number>1</number><keywords><keyword>Adult</keyword><keyword>Age Distribution</keyword><keyword>Body Mass Index</keyword><keyword>Body Weight</keyword><keyword>Comorbidity</keyword><keyword>Cross-Sectional Studies</keyword><keyword>Diabetes Mellitus, Type 2/diagnosis/*epidemiology</keyword><keyword>Female</keyword><keyword>Health Surveys</keyword><keyword>Humans</keyword><keyword>Hyperlipidemias/diagnosis/*epidemiology</keyword><keyword>Hypertension/diagnosis/*epidemiology</keyword><keyword>Logistic Models</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Military Personnel</keyword><keyword>Multivariate Analysis</keyword><keyword>Obesity/diagnosis/*epidemiology</keyword><keyword>Odds Ratio</keyword><keyword>Prevalence</keyword><keyword>Probability</keyword><keyword>Retirement</keyword><keyword>Risk Assessment</keyword><keyword>Sex Distribution</keyword><keyword>United States/epidemiology</keyword></keywords><dates><year>2005</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0091-7435 (Print)</isbn><accession-num>15916994</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite><Cite><Author>Tornberg</Author><Year>2005</Year><RecNum>38</RecNum><record><rec-number>38</rec-number><ref-type name="Conference Paper">47</ref-type><contributors><authors><author>Tornberg, David N</author></authors></contributors><titles><title>Fighting Obesity-Choose Healthy Lifestyles</title><secondary-title>TRICARE Press Room</secondary-title></titles><dates><year>2005</year></dates><urls><related-urls><url>, 2, 8. Despite the military’s stringent weight standards and physical training program, the 2005 Health Program Analysis and Evaluation Directorate stated that approximately two-thirds of active duty personnel are overweight, defined as Body Mass Index (BMI) of 25-29.9 kg/m2, with a significantly lower percentage of 12% obese (BMI ≥30) ADDIN EN.CITE <EndNote><Cite><Year>2005</Year><RecNum>39</RecNum><record><rec-number>39</rec-number><ref-type name="Report">27</ref-type><contributors></contributors><titles><title>Overweight in the Military: Issue Brief: Health Care Survey of DoD Beneficiaries</title><secondary-title>Health Program Analysis and Evaluation Directorate</secondary-title></titles><pages>3-4</pages><dates><year>2005</year></dates><urls><related-urls><url>tricare.mil/survey/hcsurvey/issue-briefCYO5Q1.pdf</url></related-urls></urls></record></Cite></EndNote>1. Military families are not any leaner than the average American population. US Military Department of Defense (DoD) healthcare beneficiaries are similar to the civilian population with 41% of adult beneficiaries overweight and 22% obese ADDIN EN.CITE <EndNote><Cite><Year>2005</Year><RecNum>39</RecNum><record><rec-number>39</rec-number><ref-type name="Report">27</ref-type><contributors></contributors><titles><title>Overweight in the Military: Issue Brief: Health Care Survey of DoD Beneficiaries</title><secondary-title>Health Program Analysis and Evaluation Directorate</secondary-title></titles><pages>3-4</pages><dates><year>2005</year></dates><urls><related-urls><url>tricare.mil/survey/hcsurvey/issue-briefCYO5Q1.pdf</url></related-urls></urls></record></Cite></EndNote>1.4.4 Military Relevance:The DoD beneficiary population includes all active duty service members, active duty retirees, and their immediate families. Currently, the DoD is one of the largest health care providers in the US; it services approximately 9.2 million people ADDIN EN.CITE <EndNote><Cite><Author>Kress</Author><Year>2005</Year><RecNum>36</RecNum><record><rec-number>36</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kress, A. M.</author><author>Hartzel, M. C.</author><author>Peterson, M. R.</author></authors></contributors><auth-address>Center for Health Care Management Studies, Office of the Assistant Secretary of Defense, Health Affairs (OASD (HA)), TRICARE Management Activity (TMA), 5111 Leesburg Pike, Suite 810, Falls Church, VA 22041-3206, USA. amii.kress@tma.osd.mil</auth-address><titles><title>Burden of disease associated with overweight and obesity among U.S. military retirees and their dependents, aged 38-64, 2003</title><secondary-title>Prev Med</secondary-title><alt-title>Preventive medicine</alt-title></titles><pages>63-9</pages><volume>41</volume><number>1</number><keywords><keyword>Adult</keyword><keyword>Age Distribution</keyword><keyword>Body Mass Index</keyword><keyword>Body Weight</keyword><keyword>Comorbidity</keyword><keyword>Cross-Sectional Studies</keyword><keyword>Diabetes Mellitus, Type 2/diagnosis/*epidemiology</keyword><keyword>Female</keyword><keyword>Health Surveys</keyword><keyword>Humans</keyword><keyword>Hyperlipidemias/diagnosis/*epidemiology</keyword><keyword>Hypertension/diagnosis/*epidemiology</keyword><keyword>Logistic Models</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Military Personnel</keyword><keyword>Multivariate Analysis</keyword><keyword>Obesity/diagnosis/*epidemiology</keyword><keyword>Odds Ratio</keyword><keyword>Prevalence</keyword><keyword>Probability</keyword><keyword>Retirement</keyword><keyword>Risk Assessment</keyword><keyword>Sex Distribution</keyword><keyword>United States/epidemiology</keyword></keywords><dates><year>2005</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0091-7435 (Print)</isbn><accession-num>15916994</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>8. This population has a significantly different lifestyle than the majority of the US population. Service members may get stationed virtually anywhere to meet the needs of the military, so active duty members and their families usually have to move frequently and are often located far from family support networks. The high deployment rate also adds to the stress of the military family life and often leaves families alone in unfamiliar places. Such a lifestyle may be emotionally and physically draining and could account for some of the difficulty associated with maintaining a healthy weight within the DoD population. Although the majority of active duty military members are required to participate in physical training at least two to three times weekly, their jobs and lifestyles may not be physically active enough to meet the minimum physical activity recommendations of 30 minutes of moderate activity on most days of the week ADDIN EN.CITE <EndNote><Cite><Author>Blair</Author><Year>2004</Year><RecNum>48</RecNum><record><rec-number>48</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Blair, S. N.</author><author>LaMonte, M. J.</author><author>Nichaman, M. Z.</author></authors></contributors><auth-address>The Cooper Institute, 12330 Preston Road, Dallas, TX 75230, USA. sblair@</auth-address><titles><title>The evolution of physical activity recommendations: how much is enough?</title><secondary-title>Am J Clin Nutr</secondary-title><alt-title>The American journal of clinical nutrition</alt-title></titles><pages>913S-920S</pages><volume>79</volume><number>5</number><keywords><keyword>Exercise/*physiology</keyword><keyword>Health Policy</keyword><keyword>Humans</keyword><keyword>Nutrition Policy</keyword><keyword>Obesity/*prevention &amp; control</keyword><keyword>*Physical Fitness</keyword><keyword>Public Health</keyword><keyword>Time Factors</keyword><keyword>United States</keyword></keywords><dates><year>2004</year><pub-dates><date>May</date></pub-dates></dates><isbn>0002-9165 (Print)</isbn><accession-num>15113739</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite><Cite><Author>Hultquist</Author><Year>2005</Year><RecNum>33</RecNum><record><rec-number>33</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hultquist, C. N.</author><author>Albright, C.</author><author>Thompson, D. L.</author></authors></contributors><auth-address>Department of Exercise, Sport, and Leisure Studies and the Center for Physical Activity and Health, University of Tennessee, Knoxville, TN 37996-2700, USA.</auth-address><titles><title>Comparison of walking recommendations in previously inactive women</title><secondary-title>Med Sci Sports Exerc</secondary-title><alt-title>Medicine and science in sports and exercise</alt-title></titles><pages>676-83</pages><volume>37</volume><number>4</number><keywords><keyword>Adult</keyword><keyword>Analysis of Variance</keyword><keyword>Body Composition</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Middle Aged</keyword><keyword>Monitoring, Ambulatory</keyword><keyword>*Motor Activity</keyword><keyword>Time Factors</keyword><keyword>Walking/*statistics &amp; numerical data</keyword></keywords><dates><year>2005</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>0195-9131 (Print)</isbn><accession-num>15809569</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>9, 10. For example, deployment requires an altered lifestyle and, depending on the job, may make it more difficult for Soldiers to maintain their regular physical activity regimens. Also, a regular physical training program is often left up to the motivation of the individual, especially in medical facilities, because Soldiers and professionals in the hospital typically work long, rotating hours, leaving organized physical activity more difficult to manage. Such high-stress and busy lifestyles do not always support increased regimented physical activity and weight loss. Spouses of military members may also find themselves too busy putting their families needs ahead of their own to successfully maintain a regular workout routine, despite free access to on-post fitness facilities. The DoD healthcare system sponsors weight loss programs in an attempt to help active duty members maintain body fat standards and family members achieve healthy BMIs. Soldiers who do not meet the body fat percentage standards for their age ADDIN EN.CITE <EndNote><Cite><Year>2006</Year><RecNum>40</RecNum><record><rec-number>40</rec-number><ref-type name="Government Document">46</ref-type><contributors></contributors><titles><title>AR 600-9: The Army Weight Control Program</title></titles><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>7, are enrolled in the Army Weight Control Program (AWCP), which includes counseling with a registered dietitian and additional physical training. A class known as “Weigh-to-Stay for Weight Control” is the educational component of the AWCP, which consists of a specific number of classroom sessions (typically two to three, depending on base standards) and online supplemental courses carried out over a nine month period ADDIN EN.CITE <EndNote><Cite><Author>Mobley</Author><Year>2006</Year><RecNum>41</RecNum><record><rec-number>41</rec-number><ref-type name="Thesis">32</ref-type><contributors><authors><author>Mobley, Amy R</author></authors><tertiary-authors><author>Professor Mark Kantor</author></tertiary-authors></contributors><titles><title>Evaluation of Behavioral Theory and Integrated Internet/Telephone Technologies to Support Military Obesity and Weight Management Programs</title><secondary-title>Philosophy</secondary-title></titles><pages>249</pages><volume>Doctor of Philosophy</volume><dates><year>2006</year></dates><pub-location>Maryland</pub-location><publisher>Graduate School of the University of Maryland</publisher><urls></urls></record></Cite></EndNote>11. There is a class designed for DoD beneficiaries known as “Weigh-for-Health” and provides similar content as the “Weigh-to-Stay” class. One of the major limiting factors of these programs is that they are designed for people in the ready ‘action’ stage of change for weight loss and may not address the psychosocial limitations associated with making lifestyle changes ADDIN EN.CITE <EndNote><Cite><Author>Mobley</Author><Year>2006</Year><RecNum>41</RecNum><record><rec-number>41</rec-number><ref-type name="Thesis">32</ref-type><contributors><authors><author>Mobley, Amy R</author></authors><tertiary-authors><author>Professor Mark Kantor</author></tertiary-authors></contributors><titles><title>Evaluation of Behavioral Theory and Integrated Internet/Telephone Technologies to Support Military Obesity and Weight Management Programs</title><secondary-title>Philosophy</secondary-title></titles><pages>249</pages><volume>Doctor of Philosophy</volume><dates><year>2006</year></dates><pub-location>Maryland</pub-location><publisher>Graduate School of the University of Maryland</publisher><urls></urls></record></Cite></EndNote>11. Individuals required by their unit command to enroll in AWCP may have difficulty losing weight through this program because they may not be ready or willing to make a change. This lack of readiness indicates that they are in the precontemplation or contemplation stage of change and are unlikely to benefit from this form of group therapy. ADDIN EN.CITE <EndNote><Cite><Author>Byrd-Bredbenner</Author><Year>2000</Year><RecNum>56</RecNum><record><rec-number>56</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Byrd-Bredbenner</author></authors></contributors><titles><title>Putting the Transtheoretical Model into Pratice with Type 2 Diabetes Mellitus Patients</title><secondary-title>Top Clinical Nutrition</secondary-title></titles><pages>44-58</pages><volume>15</volume><number>3</number><dates><year>2000</year></dates><urls></urls></record></Cite></EndNote>12 The prevalence of overweight and obesity among the DoD beneficiary population still remains high, suggesting the current programs may not be effective for all personnel. Motivational weight loss program techniques that can easily be incorporated into the military family lifestyle may be more effective at moving overweight or obese individuals along the continuum of readiness to change. The current overweight and obesity rates could pose quite a concern since military personnel must maintain adequate health and weight to meet military standards. Rising obesity-related healthcare costs are demanding extraordinary amounts of time and money from the DoD healthcare system ADDIN EN.CITE <EndNote><Cite><Author>Tornberg</Author><Year>2005</Year><RecNum>38</RecNum><record><rec-number>38</rec-number><ref-type name="Conference Paper">47</ref-type><contributors><authors><author>Tornberg, David N</author></authors></contributors><titles><title>Fighting Obesity-Choose Healthy Lifestyles</title><secondary-title>TRICARE Press Room</secondary-title></titles><dates><year>2005</year></dates><urls><related-urls><url>. Obesity is a highly preventable and controllable disease; however, its co-morbidities are among the deadliest. Obesity-related healthcare costs are rapidly increasing, possibly more so within the DoD Heath Care System. In 2004, the DoD spent 24 million dollars on bariatric surgery alone ADDIN EN.CITE <EndNote><Cite><Author>Tornberg</Author><Year>2005</Year><RecNum>38</RecNum><record><rec-number>38</rec-number><ref-type name="Conference Paper">47</ref-type><contributors><authors><author>Tornberg, David N</author></authors></contributors><titles><title>Fighting Obesity-Choose Healthy Lifestyles</title><secondary-title>TRICARE Press Room</secondary-title></titles><dates><year>2005</year></dates><urls><related-urls><url>, excluding the additional costs associated with weight loss programs and hospital care related to obesity co-morbidities.With the majority of active duty military members and DoD beneficiaries exhibiting overweight- and obese-level BMIs, the military would benefit from a simple, cost-effective, easily distributable weight loss tool. If this program was successful, it could be incorporated into the current Weigh to Stay and Weigh for Health programs to facilitate permanent lifestyle change.4.5 Background: (The military relevance and the background justify the need and approach for a study; jot down the type of information you feel is missing to support why this study was conducted) Walking ProgramsIn general, weight loss or exercise programs tend to have a very low retention rate with an estimated 40-65% of participants expected to drop out of a regimented exercise program within three to six months of joining ADDIN EN.CITE <EndNote><Cite><Author>Rooney</Author><Year>2003</Year><RecNum>7</RecNum><record><rec-number>7</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rooney, B.</author><author>Smalley, K.</author><author>Larson, J.</author><author>Havens, S.</author></authors></contributors><auth-address>Gundersen Lutheran Medical Center, La Crosse, Wis. 54601, USA. blrooney@</auth-address><titles><title>Is knowing enough? Increasing physical activity by wearing a pedometer</title><secondary-title>Wmj</secondary-title></titles><pages>31-6</pages><volume>102</volume><number>4</number><keywords><keyword>Adult</keyword><keyword>Analysis of Variance</keyword><keyword>Chi-Square Distribution</keyword><keyword>*Exercise Therapy</keyword><keyword>Female</keyword><keyword>Health Promotion/*methods</keyword><keyword>Humans</keyword><keyword>*Walking</keyword><keyword>Wisconsin</keyword><keyword>*Women, Working</keyword></keywords><dates><year>2003</year></dates><isbn>1098-1861 (Print)</isbn><accession-num>12967019</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>13. Numerous studies indicate that people are more likely to lose and maintain weight loss by modifying their lifestyles to incorporate physical activity and small diet changes into their daily routines rather than attempting to adhere to an intense diet or exercise program ADDIN EN.CITE <EndNote><Cite><Author>Borg</Author><Year>2002</Year><RecNum>11</RecNum><record><rec-number>11</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Borg, P.</author><author>Kukkonen-Harjula, K.</author><author>Fogelholm, M.</author><author>Pasanen, M.</author></authors></contributors><auth-address>UKK Institute for Health Promotion Research, Tampere, Finland. patrik.borg@helsinki.fi</auth-address><titles><title>Effects of walking or resistance training on weight loss maintenance in obese, middle-aged men: a randomized trial</title><secondary-title>Int J Obes Relat Metab Disord</secondary-title></titles><pages>676-83</pages><volume>26</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>Body Composition</keyword><keyword>Body Constitution</keyword><keyword>Diet, Reducing</keyword><keyword>Energy Intake</keyword><keyword>Energy Metabolism</keyword><keyword>*Exercise</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Obesity/*therapy</keyword><keyword>*Walking</keyword><keyword>*Weight Loss</keyword></keywords><dates><year>2002</year><pub-dates><date>May</date></pub-dates></dates><isbn>0307-0565 (Print)</isbn><accession-num>12032753</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite><Cite><Author>Dicken-Kano</Author><Year>2006</Year><RecNum>9</RecNum><record><rec-number>9</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dicken-Kano, R.</author><author>Bell, M. M.</author></authors></contributors><titles><title>Pedometers as a means to increase walking and achieve weight loss</title><secondary-title>J Am Board Fam Med</secondary-title></titles><pages>524-5</pages><volume>19</volume><number>5</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Body Mass Index</keyword><keyword>Exercise Therapy/*methods</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Middle Aged</keyword><keyword>Obesity/physiopathology/*therapy</keyword><keyword>Treatment Outcome</keyword><keyword>Walking/*physiology</keyword><keyword>Weight Loss/*physiology</keyword></keywords><dates><year>2006</year><pub-dates><date>Sep-Oct</date></pub-dates></dates><isbn>1557-2625 (Print)</isbn><accession-num>16951304</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite><Cite><Author>Rooney</Author><Year>2003</Year><RecNum>7</RecNum><record><rec-number>7</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rooney, B.</author><author>Smalley, K.</author><author>Larson, J.</author><author>Havens, S.</author></authors></contributors><auth-address>Gundersen Lutheran Medical Center, La Crosse, Wis. 54601, USA. blrooney@</auth-address><titles><title>Is knowing enough? Increasing physical activity by wearing a pedometer</title><secondary-title>Wmj</secondary-title></titles><pages>31-6</pages><volume>102</volume><number>4</number><keywords><keyword>Adult</keyword><keyword>Analysis of Variance</keyword><keyword>Chi-Square Distribution</keyword><keyword>*Exercise Therapy</keyword><keyword>Female</keyword><keyword>Health Promotion/*methods</keyword><keyword>Humans</keyword><keyword>*Walking</keyword><keyword>Wisconsin</keyword><keyword>*Women, Working</keyword></keywords><dates><year>2003</year></dates><isbn>1098-1861 (Print)</isbn><accession-num>12967019</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite><Cite><Author>Tudor-Locke</Author><Year>2002</Year><RecNum>46</RecNum><record><rec-number>46</rec-number><ref-type name="Magazine Article">19</ref-type><contributors><authors><author>Tudor-Locke, C.</author></authors></contributors><titles><title>Taking Steps Toward Increased Physical Activity: Using Pedometers to Measure and Motivate</title><secondary-title>Research Digest: President&apos;s Council on Physical Fitness and Sports</secondary-title></titles><volume>3</volume><number>17</number><dates><year>2002</year><pub-dates><date>June 2002</date></pub-dates></dates><work-type>President&apos;s Council</work-type><urls></urls></record></Cite></EndNote>13-16. This concept of ‘lifestyle change’ is essentially the basis of walking programs and motivational weight loss counseling. For example, the First Step Program developed for overweight diabetics is based on the Social Cognitive Theory which promotes healthy lifestyle modifications by means of self-monitoring, goal-setting, personal reflection, and refinement ADDIN EN.CITE <EndNote><Cite><Author>Tudor-Locke</Author><Year>2002</Year><RecNum>46</RecNum><record><rec-number>46</rec-number><ref-type name="Magazine Article">19</ref-type><contributors><authors><author>Tudor-Locke, C.</author></authors></contributors><titles><title>Taking Steps Toward Increased Physical Activity: Using Pedometers to Measure and Motivate</title><secondary-title>Research Digest: President&apos;s Council on Physical Fitness and Sports</secondary-title></titles><volume>3</volume><number>17</number><dates><year>2002</year><pub-dates><date>June 2002</date></pub-dates></dates><work-type>President&apos;s Council</work-type><urls></urls></record></Cite></EndNote>16. This approach encourages individuals to make manageable weight loss decisions on their own and has shown to be highly effective in promoting lifestyle change. The program specifically focuses on increasing daily activity by increasing the number of steps taken throughout a person’s daily routine. Although walking is not the most efficient way to burn calories for weight loss, it may be the most effective method for initiating lifestyle changes associated with weight loss and weight loss maintenance. Typically, individuals find incorporating extra steps into their daily routines easier than adding an entire workout regimen. Walking as a home-based, lifestyle intervention technique appears to be more successful in promoting long-term adherence compared to a treadmill-based or structured walking program ADDIN EN.CITE <EndNote><Cite><Author>Borg</Author><Year>2002</Year><RecNum>11</RecNum><record><rec-number>11</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Borg, P.</author><author>Kukkonen-Harjula, K.</author><author>Fogelholm, M.</author><author>Pasanen, M.</author></authors></contributors><auth-address>UKK Institute for Health Promotion Research, Tampere, Finland. patrik.borg@helsinki.fi</auth-address><titles><title>Effects of walking or resistance training on weight loss maintenance in obese, middle-aged men: a randomized trial</title><secondary-title>Int J Obes Relat Metab Disord</secondary-title></titles><pages>676-83</pages><volume>26</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>Body Composition</keyword><keyword>Body Constitution</keyword><keyword>Diet, Reducing</keyword><keyword>Energy Intake</keyword><keyword>Energy Metabolism</keyword><keyword>*Exercise</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Obesity/*therapy</keyword><keyword>*Walking</keyword><keyword>*Weight Loss</keyword></keywords><dates><year>2002</year><pub-dates><date>May</date></pub-dates></dates><isbn>0307-0565 (Print)</isbn><accession-num>12032753</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>14. This simplification of physical activity may provide individuals with the level of self-efficacy needed to make small daily changes that could last a lifetime. A 12-week intervention study conducted on 106 sedentary workers showed an average increase of over 3,000 steps per day (60% of original participants completed the study) ADDIN EN.CITE <EndNote><Cite><Author>Chan</Author><Year>2004</Year><RecNum>34</RecNum><record><rec-number>34</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chan, C. B.</author><author>Ryan, D. A.</author><author>Tudor-Locke, C.</author></authors></contributors><auth-address>Department of Biomedical Sciences, University of Prince Edward Island, Charlottetown, PE, Canada C1A 4P3. cchan@upei.ca</auth-address><titles><title>Health benefits of a pedometer-based physical activity intervention in sedentary workers</title><secondary-title>Prev Med</secondary-title><alt-title>Preventive medicine</alt-title></titles><pages>1215-22</pages><volume>39</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Blood Pressure</keyword><keyword>Body Mass Index</keyword><keyword>Female</keyword><keyword>Heart Rate</keyword><keyword>Humans</keyword><keyword>Japan</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Multivariate Analysis</keyword><keyword>Occupational Health/*statistics &amp; numerical data</keyword><keyword>Occupational Health Services/methods/statistics &amp; numerical data</keyword><keyword>Physical Fitness/*physiology</keyword><keyword>Regression Analysis</keyword><keyword>Walking/*physiology/statistics &amp; numerical data</keyword><keyword>Workplace</keyword></keywords><dates><year>2004</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0091-7435 (Print)</isbn><accession-num>15539058</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>5. This study, among others, demonstrates that even individuals with very hectic lifestyles and limited time for structured exercise can find simple ways to increase daily physical activity by adding steps to their daily routines. This may be a highly effective concept for military personnel and their family members when their life situations do not warrant the time or the means for structured exercise. Pedometers Although research has determined a specific steps per day recommendation for potential health benefits, manually tracking a person’s steps taken during their daily routine was once thought to be more difficult than measuring the amount of activity in a set, measurable bout of exercise. Self-monitoring devices, specifically pedometers, are becoming more and more popular as a means to measure daily physical activity outside of the gym. Pedometers are electric, battery-operated devices that measure vertical movements; when placed on the waist, they are highly effective at measuring walking motion. Rather than measuring specific distance, speed, or intensity, pedometers are most accurate in measuring steps taken at normal (54m/min) ADDIN EN.CITE <EndNote><Cite><Author>Masurier</Author><Year>2003</Year><RecNum>50</RecNum><record><rec-number>50</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Masurier, Guy C</author></authors></contributors><titles><title>Comparison of Pedometer and Accelerometer Accuracy under Controlled Conditions</title><secondary-title>Official Journal of the American College of Sports Medicine</secondary-title></titles><pages>867-871</pages><dates><year>2003</year></dates><urls><related-urls><url> or ‘brisk’ speeds (80m/min) ADDIN EN.CITE <EndNote><Cite><Author>Swartz</Author><Year>2003</Year><RecNum>29</RecNum><record><rec-number>29</rec-number><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Swartz, A. M.</author><author>Bassett, D. R., Jr.</author><author>Moore, J. B.</author><author>Thompson, D. L.</author><author>Strath, S. J.</author></authors></contributors><auth-address>Department of Health, Safety and Exercise Science, The University of Tennessee, Knoxville, 37996-2700, USA. annswar@umich.edu</auth-address><titles><title>Effects of body mass index on the accuracy of an electronic pedometer</title><secondary-title>Int J Sports Med</secondary-title><alt-title>International journal of sports medicine</alt-title></titles><pages>588-92</pages><volume>24</volume><number>8</number><keywords><keyword>Adult</keyword><keyword>*Body Mass Index</keyword><keyword>Ergometry/*instrumentation/*standards</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Monitoring, Ambulatory/*instrumentation/*standards</keyword><keyword>Obesity/*physiopathology</keyword><keyword>Reproducibility of Results</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Walking/*physiology</keyword></keywords><dates><year>2003</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>0172-4622 (Print)</isbn><accession-num>14598195</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>28. New Lifestyles is the U.S. distributor of the Yamax Digi-Walker SW200 pedometer and offers an Internet website known as “Every Step Counts”. The service is only available with the purchase of one of several pedometer packages and requires a user password. The website offers several options: 1) Log daily steps taken. 2) View weekly, monthly and yearly progress. 3) Track progress as a measure of distance across the State of Texas (a choice of several walking paths). It provides total distance traveled, daily miles, and miles to the designation based on stride length entered in the personal profile. 4) Monitor changes in BMI (kg/m2) and comparison with five BMI categories (ranging from underweight to severely obese). 5) Calculate estimated calories expended with examples of calories/minute for various activities and the estimated equivalence in steps per minute. 6) Track and view progress of all members of a particular group and add comments/feedback as an interactive function. 7) Track daily number of servings from each food guide pyramid food groups, although limited education is included on the food guide pyramid. 8) View and add suggestions, personal struggles, information in the media, etc., to a Community Forum section, where users can ask questions or provide comments as an interactive function. Specific studies evaluating the website effectiveness were not available.The purpose of this study is to evaluate the effectiveness of pedometer use with an interactive website within the DoD beneficiary population. 4.6 Research Design and Methods:Research design: This study will use a cross-sectional descriptive study.Procedures: Following IRB approval, eligible beneficiaries will be recruited from BAMC, with recruitment expanded to Fort Sam Houston sites if necessary. Once participants are recruited, they will attend an information session. Participants will sign up for a baseline data collection session. All participants will complete a demographic and background survey, and complete the physical activity questionnaire. The investigators will obtain baseline anthropometric and clinical measurements and assign a blinded pedometer. Free nutrition counseling will be provided. Participants will report one week later and will turn in their blinded pedometers to be assigned to one of two groups: intervention vs. control. Those who are randomized to the control group will only wear the blinded pedometers four weeks throughout the six-month study. They will be instructed to continue normal lifestyle habits and not to alter their physical activity in particular. Those who are randomized into the pedometer group will have their pedometers returned and will be told how to create a goal and use the New Lifestyles “Every Step Counts” website. Investigators will collect the pedometer group steps per day weekly from the website and will encourage the pedometer group to increase daily steps. At the end of the study and at follow-up, all participants will repeat the methods. One week prior to each data collection point, participants will be reminded to come. Participants will receive a Program T-shirt and be able to keep the pedometer if they complete the program. Each participant will also complete a program satisfaction survey to assess ease of use, barriers and technical problems encountered during the study and with the pedometer and interactive website. Randomization: After giving consent, subjects will be assigned to the pedometer or control group. 4.7 Instrumentation:A New Lifestyles Pedometer will be used. It has a clip designed to attach directly to participant clothing at waist level, a pedometer security strap, and an online membership to the New Lifestyles Tracking Website (). The website allows participants to track their progress throughout the course of the study, view graphs displaying daily step information, set new daily or weekly goals, communicate directly with the investigators, estimate calorie expenditure, and view tips to increase walking. As an extra source of motivation, the website offers the ability to track mileage across the United States. The pedometer group of this study will be set up with the ‘Walk across Texas’ goal, and participants will be able to view progress across Texas throughout the duration of the study.Physical Assessment of Risk Questionnaire (PAR-Q) (Appendix 3) will be used to screen for risk of participating and depending upon the responses to the PAR-Q the potential participant will be required to see their primary care provider for approval to participate in this study.Demographic and background survey data (Appendix 2), a physical activity survey (Appendix 4), and the Study Satisfaction survey (Appendix 6) data will be coded and entered into an Excel data spreadsheet.Primary and secondary outcome variables will be measured and analyzed as described in Table 1 (See Appendix 7 for data collection worksheets).Table 1 Outcome VariablesVariable NameOperational Definition (Method of Collection)Measurement TimesAnalysis MethodPrimary OutcomeStep-countDaily step-counts averaged for a week valueBaseline, 6 weeks, 12 weeks, 6 monthsWhich test? Central ObesityAbdominal girth Baseline, 6 weeks, 12 weeks, 6 monthsWhich test? Secondary OutcomeBMICalculated formula (kg/m2) from measured height (in stocking feet) and weight (as measured by digital scale)Baseline, 6 weeks, 12 weeks, 6 monthsDescriptive data % Body FatCalculated formula from AR 600-9; neck and stomach for men and neck, stomach and hip for female. Circumferences are measured 2-3 times with a tape measure to nearest ? cm and averagedBaseline, 6 weeks, 12 weeks, 6 monthsDescriptive dataSystolic BPMeasured with Aneroid Sphygmomanometer twice and averaged (per BAMC BP protocol & standard practice)Baseline, 6 weeks, 12 weeks, 6 monthsDescriptive dataDiastolic BPMeasured with Aneroid Sphygmomanometer twice and averaged (per BAMC BP protocol & standard practice)Baseline, 6 weeks, 12 weeks, 6 monthsDescriptive dataHeart RatePulse measured at radial nerve (beats per minute) twice and averagedBaseline, 6 weeks, 12 weeks, 6 monthsDescriptive dataExercise LevelSurveyBaseline, 6 weeks, 12 weeks, 6 monthsDescriptive dataStep GoalNumber of weeks to reach 10,000 daily steps6 monthsWhich test?Demographic InformationAge, sex, marital status, race/ethnic group, education, income, alcohol use, tobacco useBaselineDescriptive statisticsSatisfaction InformationSurvey6 monthsDescriptive statistics4.8 Inclusion/exclusion criteria:Inclusion: Participants must be free-walking, overweight or obese (≥ 25 BMI), adult (age ≥ 18 yr) DoD beneficiaries (DEERS eligible) with access to Internet service. Soldiers must have >1 yr of service remaining on contract and all participants must plan to be in the area for at least nine additional months. Participants identified as at risk by the PAR-Q (Appendix 3) must have written approval from a health care provider.Exclusion: None4.9 Number of Subjects: 120 total participants.5.0 Human Subject Protection5.1 Recruitment: Participants will be recruited from Brooke Army Medical Center (Troop Command and Companies) and Fort Sam Houston located in San Antonio, Texas. Recruitment will begin two months prior to initiation of the study. Flyers / posters (see Appendix 8) will be posted on the BAMC email distribution, at the Army Community Center, at the AMEDD Center and School and at MEDCOM. The flyer will briefly describe the study and provide investigator contact information to sign up for recruitment information sessions. Recruitment sessions will consist of small groups of potential participants offered weekly with alternating times and days of the week in order to maximize participation and convenience for individuals interested in the study. The recruiting information sessions will be provided by the investigators with detailed information about the study and what participation in the study would entail (see Appendix 9). An information handout will be given to each prospective participant, as well as the consent form (see Appendix 1) and HIPAA disclosure (see Appendix 10). The PAR-Q (Appendix 3) will be given to the patients at recruitment to take home and fill out. If the patient screens at risk, the form must be given to a health care provider for written approval to participate and returned during baseline data collection.5.2 Costs: There is no cost to the volunteer to participate.5.3 Benefits: There is no guarantee that participants will directly benefit from the study. 5.4 Risks: Risk to subjects is minimal. 5.5 Safeguards for Protecting Subjects & Data Management: All data and medical information obtained will be considered privileged and held in confidence. This information will be kept in a locked office and accessed only if necessary by the research team. A unique study subject ID number will be assigned to each volunteer that will not contain any personal identifiers such as name, social security number, address, date of birth, zip code, etc., and that only this study subject ID number will be used on all data collection instruments, to include questionnaires, data collection forms, computer records, etc. A Master List linking the subject's personal identifiers with the subject ID number will be kept by the principal investigator in a separate locked file in a locked office. Access to the master list will be restricted to the PI and one AI. Hard copy data records will be stored for a minimum of 3 years from the time the study is completed, and then destroyed. No information will be included when the research is published or discussed in conferences that would reveal the identity of the subjects. 5.6 Risk:Benefit Assessment / Compensation: The risks of participating in this study are minimal. Subjects will receive free feedback, basic nutrition counseling, and clinical measurements as part of this protocol, which may assist them in making lifestyle changes to improve their health. 5.7 Alternatives: Nutrition counseling is recommended to accompany a physical activity program. As an alternative to participating in this study, an individual could attend the weight management classes offered by the Nutrition Care Division. Other forms of physical activity may be appropriate for those having difficulty increasing daily steps per day, thus the participant can choose not to participate.6.0 Data Analysis: In this study, the independent variables are treatment (control, pedometer) and time (0, 6, 12 weeks and 6 months). The dependent variables are steps per day, waist circumference and BMI. Based on what you’ve read and learned in the pre-workshop: What is the null hypothesis?What is the alternate hypothesis?What statistical methods are appropriate for this protocol?7.0 Sample size estimation/power analysis: The investigators expect a mean + standard deviation of 4000 ± 1000 steps per day in both groups at zero (0) weeks. An increase to 8000 steps per day will be clinically significant (4 SD effect size). Five comparisons on a one-tailed test are appropriate for this design, so a Bonferroni correction of p = 0.05 / (2 * 5) = 0.005 was used in the power analysis. We used SPSS Sample Power 2.0 to perform the power analysis. According to this method, 4 subjects per group (8 total) will be needed to detect a 4 SD effect size with a level of confidence of 95% and a power of 80%. The investigators expect the effect sizes with waist circumference and BMI to be 0.24 SD and 0.26 SD, respectively. The investigators expect to have 30 to 40 subjects per group. Thirty (30) subjects per group will be sufficient to detect a 0.74 SD effect size group. Forty (40) subjects per group will be sufficient to detect a 0.64 SD effect size group. The sample size will have enough power to detect the expected difference in steps per day, but not enough to detect the expected differences in waist circumference and BMI.8.0 Duration of Study: Six months: three months active study period followed by three-month follow up period.9.0 Funding: Funding is requested for pedometers and participant incentives with a total estimated cost of $2450.45.New Lifestyle products: Pedometers with security straps (65 x $16 + $40 shipping fee) = $1080 Security straps for pedometers already purchased by AMEDD C&S (65 x $1.50) = $97.50 Activity log packs (24 pk x $5) = $120 Health & Fitness Fact Sheet CD Rom with reproducible handouts = $12.95Midpoint prize drawing (12 X $10) = $120End program t-shirts (120 x $8.5) = $1020 Total = $2450.4510.0 Staff Monitor: N/A11.0 Research Assistants: N/A12.0 Bibliography: ADDIN EN.REFLIST 1.Overweight in the Military: Issue Brief: Health Care Survey of DoD Beneficiaries 2005.2.Tornberg DN. Fighting Obesity-Choose Healthy Lifestyles. TRICARE Press Room; 2005.3.Tudor-Locke C, Williams JE, Reis JP, Pluto D. Utility of pedometers for assessing physical activity: construct validity. Sports Med. 2004;34(5):281-291.4.Richardson CR, Brown BB, Foley S, Dial KS, Lowery JC. Feasibility of adding enhanced pedometer feedback to nutritional counseling for weight loss. J Med Internet Res. 2005;7(5):e56.5.Chan CB, Ryan DA, Tudor-Locke C. Health benefits of a pedometer-based physical activity intervention in sedentary workers. Prev Med. Dec 2004;39(6):1215-1222.6.Garbers S. Using Pedometers to Promote Physical Activity Among Working Urban Women. Preventative Chronic Disease. April 2006 2006;3:67.7.AR 600-9: The Army Weight Control Program; 2006.8.Kress AM, Hartzel MC, Peterson MR. Burden of disease associated with overweight and obesity among U.S. military retirees and their dependents, aged 38-64, 2003. Prev Med. Jul 2005;41(1):63-69.9.Blair SN, LaMonte MJ, Nichaman MZ. The evolution of physical activity recommendations: how much is enough? Am J Clin Nutr. May 2004;79(5):913S-920S.10.Hultquist CN, Albright C, Thompson DL. Comparison of walking recommendations in previously inactive women. Med Sci Sports Exerc. Apr 2005;37(4):676-683.11.Mobley AR. Evaluation of Behavioral Theory and Integrated Internet/Telephone Technologies to Support Military Obesity and Weight Management Programs. Maryland: Philosophy, Graduate School of the University of Maryland; 2006.12.Byrd-Bredbenner. Putting the Transtheoretical Model into Pratice with Type 2 Diabetes Mellitus Patients. Top Clinical Nutrition. 2000;15(3):44-58.13.Rooney B, Smalley K, Larson J, Havens S. Is knowing enough? Increasing physical activity by wearing a pedometer. Wmj. 2003;102(4):31-36.14.Borg P, Kukkonen-Harjula K, Fogelholm M, Pasanen M. Effects of walking or resistance training on weight loss maintenance in obese, middle-aged men: a randomized trial. Int J Obes Relat Metab Disord. May 2002;26(5):676-683.15.Dicken-Kano R, Bell MM. Pedometers as a means to increase walking and achieve weight loss. J Am Board Fam Med. Sep-Oct 2006;19(5):524-525.16.Tudor-Locke C. Taking Steps Toward Increased Physical Activity: Using Pedometers to Measure and Motivate. Research Digest: President's Council on Physical Fitness and Sports. Vol 3; 2002.17.Swartz AM, Strath SJ, Bassett DR, et al. Increasing daily walking improves glucose tolerance in overweight women. Prev Med. Oct 2003;37(4):356-362.18.Yamanouchi K, Shinozaki T, Chikada K, et al. Daily walking combined with diet therapy is a useful means for obese NIDDM patients not only to reduce body weight but also to improve insulin sensitivity. Diabetes Care. Jun 1995;18(6):775-778.19.Wilson DB, Porter JS, Parker G, Kilpatrick J. Anthropometric changes using a walking intervention in African American breast cancer survivors: a pilot study. Prev Chronic Dis. Apr 2005;2(2):A16.20.Thompson DL, Rakow J, Perdue SM. Relationship between accumulated walking and body composition in middle-aged women. Med Sci Sports Exerc. May 2004;36(5):911-914.21.Tudor-Locke C. The relationship between pedometer-determined ambulatory activity and body composition variables. International Journal of Obesity. 2001;25:1571-1578.22.Williams PT. Nonlinear relationships between weekly walking distance and adiposity in 27,596 women. Med Sci Sports Exerc. Nov 2005;37(11):1893-1901.23.Saris W. How much physical activity is enough to prevent unhealthy weight gain? Outcome of the IASO 1st Stock Conference and consensus statement. Obesity Review. May 2003 2003;4(2):101-114.24.Schartz HA, O'Day B, Blanck P. Introduction to this issue: disability, public policy, and technology. Behav Sci Law. 2003;21(1):1-3.25.Welk G. The utility of the Digi-walker step counter to assess daily physical activity patterns. Official Journal of the American College of Sports Medicine. 2000:481-488.26.Tudor-Locke C, Bassett DR, Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8.27.Masurier GC. Comparison of Pedometer and Accelerometer Accuracy under Controlled Conditions. Official Journal of the American College of Sports Medicine. 2003:867-871.28.Swartz AM, Bassett DR, Jr., Moore JB, Thompson DL, Strath SJ. Effects of body mass index on the accuracy of an electronic pedometer. Int J Sports Med. Nov 2003;24(8):588-592.29.Schneider P. Pedometer Measures of Free-Living Physical Activity: Comparison of 13 Models. Official Journal of the American College of Sports Medicine. 2004:331-335.30.Tudor-Locke CE, Myers AM. Challenges and opportunities for measuring physical activity in sedentary adults. Sports Med. Feb 2001;31(2):91-100.31.Gleeson-Kreig JM. Self-monitoring of physical activity: effects on self-efficacy and behavior in people with type 2 diabetes. Diabetes Educ. Jan-Feb 2006;32(1):69-77.32.Tudor-Locke C, Sisson SB, Collova T, Lee SM, Swan PD. Pedometer-determined step count guidelines for classifying walking intensity in a young ostensibly healthy population. Can J Appl Physiol. Dec 2005;30(6):666-676.33. Jensen G, Roy M-A, Buchanan A, Berg M. Weight loss intervention for obese older women: Improvements in performance and function. Obesity Research. Nov 2004;12(11):1814-1820.34. Villanova N, Pasqui F, Burzacchini S, Forlani G, Manini R, Suppini A, Melchionda N, Marchesini G. A physical activity program to reinforce weight maintenance following a behavior program in overweight/obese subjects. Int'l J of Obesity. 2006;30:697-703.13.0 Support Services Required (Impact Statement/Letter of Support): see attached14.0 Use of Investigation Drugs: N/A15.0 Use of Investigational Devices: N/A16.0 Signature Section:16.1 Principle InvestigatorI am aware that I am not authorized to accept any funds or other form of compensation for conducting research. All subjects will be treated in compliance with all applicable organizational, service, DoD, and Federal regulations, and all applicable FDA and HHS guidelines._______________________ Date of Protocol Submission: ___________(before approval)Renee E. Cole, PhD, RD, LD, SPChief, Outpatient NutritionNutrition Care DivisionBrooke Army Medical Center16.2 Associate and Other Investigator Signature PageI have read the above protocol and agree with its content. All subjects will be treated in compliance with all applicable organizational, service, DoD, and Federal regulations, and all applicable FDA and HHS guidelines._________________________Date _______________2LT Yu Knomee, BS, SPGraduate Student, Dietetic Consortium_________________________Date _______________Ida K. Areboutit, BA, FAACVPR, GS-12, DACExercise Physiologist, Cardiology Clinic,Department of Medicine_________________________Date _______________Wah T. Supp, BS, ContractorCardiac Rehabilitative Therapist, Cardiology Clinic, Department of Medicine16.3 PI’s Service Chief (BAMC)I have considered this protocol and am able to approve BAMC Nutrition Care Division personnel and resource support. As the department chief I understand that I will be point of contact for correction of deficiencies._________________________ Iwana Mortime5 June 2007Colonel, SPChief, Nutrition Care Division-------------------------------------------------------------------------------------------------------------------- 16.4 Scientific Merit Review: This protocol has been reviewed and found to have sufficient scientific merit for consideration by the Institution Review Board.APPENDICES1. BAMC Pedometer Study Consent Form2. Demographic and Background survey3. Physical Assessment of Risk questionnaire (PAR-Q)4. International Physical Activity questionnaire5. Nutrition Guidance Handouts6. Program Satisfaction Survey7. Data Collection Worksheet8. Recruitment Flyer9. Recruitment Presentation10. HIPAA Disclosure ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download