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Incomplete Protocol Example Exercise
Instructions:
1. Print out the Protocol Element Checklist.
2. Read the following Protocol Example.
3. As you read the protocol think about the checklist and identify areas for
improvement (there will be plenty).
4. Complete this exercise after completing the 6 pre-workshop classes and
prior to the residence phase of the course.
5. Plan to discuss your finding during the MLH Practical Exercise #1 on 2
May.
6. 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.
7. Good Luck!!
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BAMC/WHMC
PROTOCOL FOR CLINICAL INVESTIGATIONS -- HUMAN
1.0 Title: Effectiveness of a pedometer and interactive website in motivating Service Members
and DoD beneficiaries to reach a 10,000 steps per day goal
2.0 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 Center
3851 Roger Brooke Drive
Fort Sam Houston, Texas 78234
renee.cole@amedd.army.mil
Phone: (210) XXX-XXXX
2.1 Associate Investigator:
2LT Yu Knomee, BS, U.S. Army Medical Specialist Corps (Army Dietitian)
Graduate Student, Army Dietetic Internship
yu.knowmee@us.army.mil
Phone: (210) XXX-XXXX
2.2 Other Investigators:
Ida K. Areboutit, BA, FAACVPR, GS-12, DAC (Director of Cardiopulmonary Rehabilitation)
Cardiology Clinic, Dept of Medicine, HSHE-MDC
Brooke Army Medical Center
3851 Roger Brooke Drive
Fort Sam Houston, Texas 78234
Ida.k.areboutit@amedd.army.mil
Phone: (210) XXX-XXXX
Wah T. Supp, BS, Contractor, Cardiac Rehabilitation Therapist
Cardiology Clinic, Dept of Medicine, HSHE-MDC
Brooke Army Medical Center
3851 Roger Brooke Drive
Fort Sam Houston, Texas 78234
wah.t.supp@amedd.army.mil
Phone: (210) XXX-XXXX
3.0 Location: Brooke Army Medical Center, Fort Sam Houston, Texas 78234
4.0 Research Plan
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4.1 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:
1) Use of a pedometer with interactive website will motivate participants to significantly
increase their steps per day.
2) 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).
3) 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:
1) Will pedometer use lead to 10,000 steps per day?
2) Will increased activity improve health?
3) 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 1,
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)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 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 people8. This population has a
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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 week9, 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 age7, 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 period11. There is a class designed for DoD beneficiaries known as “Weighfor-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 changes11. 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.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 system2. 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 alone2, excluding the additional costs associated
with weight loss programs and hospital care related to obesity co-morbidities.
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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 Programs
In 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 joining13. 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 program13-16. 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
refinement16. 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 program14. 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)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,
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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)27 or ‘brisk’ speeds (80m/min)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.
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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.
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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.
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.
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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 (www.everystepcounts.com). 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 Variables
Variable Name Operational Definition
Measurement Times
(Method of Collection)
Primary Outcome
Step-count
Central Obesity
Daily step-counts averaged for a
week value
Abdominal girth
Baseline, 6 weeks, 12
weeks, 6 months
Baseline, 6 weeks, 12
weeks, 6 months
Analysis Method
Which test?
Which test?
Secondary Outcome
BMI
% Body Fat
Systolic BP
Calculated formula (kg/m2) from
measured height (in stocking feet)
and weight (as measured by
digital scale)
Calculated formula from AR 6009; neck and stomach for men and
neck, stomach and hip for female.
Circumferences are measured 2-3
times with a tape measure to
nearest ½ cm and averaged
Measured with Aneroid
Sphygmomanometer twice and
averaged (per BAMC BP protocol
Baseline, 6 weeks, 12
weeks, 6 months
Descriptive data
Baseline, 6 weeks, 12
weeks, 6 months
Descriptive data
Baseline, 6 weeks, 12
weeks, 6 months
Descriptive data
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Diastolic BP
Heart Rate
Exercise Level
Step Goal
Demographic
Information
Satisfaction
Information
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& standard practice)
Measured with Aneroid
Sphygmomanometer twice and
averaged (per BAMC BP protocol
& standard practice)
Pulse measured at radial nerve
(beats per minute) twice and
averaged
Survey
Number of weeks to reach 10,000
daily steps
Age, sex, marital status,
race/ethnic group, education,
income, alcohol use, tobacco use
Survey
Baseline, 6 weeks, 12
weeks, 6 months
Descriptive data
Baseline, 6 weeks, 12
weeks, 6 months
Descriptive data
Baseline, 6 weeks, 12
weeks, 6 months
6 months
Descriptive data
Baseline
Descriptive statistics
6 months
Descriptive statistics
Which test?
4.8 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: None
4.9 Number of Subjects: 120 total participants.
5.0 Human Subject Protection
5.1 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.
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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
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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 =
$12.95
Midpoint prize drawing (12 X $10) =
$120
End program t-shirts (120 x $8.5) =
$1020
Total = $2450.45
10.0 Staff Monitor: N/A
11.0 Research Assistants: N/A
12.0 Bibliography:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Overweight in the Military: Issue Brief: Health Care Survey of DoD Beneficiaries 2005.
Tornberg DN. Fighting Obesity-Choose Healthy Lifestyles. TRICARE Press Room; 2005.
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.
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.
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.
Garbers S. Using Pedometers to Promote Physical Activity Among Working Urban
Women. Preventative Chronic Disease. April 2006 2006;3:67.
AR 600-9: The Army Weight Control Program; 2006.
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.
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.
Hultquist CN, Albright C, Thompson DL. Comparison of walking recommendations in
previously inactive women. Med Sci Sports Exerc. Apr 2005;37(4):676-683.
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.
Byrd-Bredbenner. Putting the Transtheoretical Model into Pratice with Type 2 Diabetes
Mellitus Patients. Top Clinical Nutrition. 2000;15(3):44-58.
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Effectiveness of a pedometer and interactive website in motivating Service Members and DoD beneficiaries to reach
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13.0 Support Services Required (Impact Statement/Letter of Support): see attached
14.0 Use of Investigation Drugs: N/A
15.0 Use of Investigational Devices: N/A
16.0 Signature Section:
16.1 Principle Investigator
I 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, SP
Chief, Outpatient Nutrition
Nutrition Care Division
Brooke Army Medical Center
16.2 Associate and Other Investigator Signature Page
I 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.
_________________________
2LT Yu Knomee, BS, SP
Graduate Student, Dietetic Consortium
Date _______________
_________________________
Ida K. Areboutit, BA, FAACVPR, GS-12, DAC
Exercise Physiologist, Cardiology Clinic,
Department of Medicine
Date _______________
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_________________________
Wah T. Supp, BS, Contractor
Cardiac Rehabilitative Therapist,
Cardiology Clinic, Department of Medicine
Date _______________
16.3 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 Mortime
5 June 2007
Colonel, SP
Chief, 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.
APPENDICES
1. BAMC Pedometer Study Consent Form
2. Demographic and Background survey
3. Physical Assessment of Risk questionnaire (PAR-Q)
4. International Physical Activity questionnaire
5. Nutrition Guidance Handouts
6. Program Satisfaction Survey
7. Data Collection Worksheet
8. Recruitment Flyer
9. Recruitment Presentation
10. HIPAA Disclosure
13