Effectiveness of a pedometer and interactive website in motivating Service Members and DoD beneficiaries to reach a 10,000 steps per day goal
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!!
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
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
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
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
Phone: (210) XXX-XXXX
3.0 Location: Brooke Army Medical Center, Fort Sam Houston, Texas 78234
4.0 Research Plan
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 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 “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 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.
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, 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.
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.