- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556112
Effectiveness of a Group Lifestyle Balance Class in a Military Population
Study Overview
Status
Conditions
Detailed Description
Many active duty personnel struggle with weight gain and becoming overweight during the course of their active duty service. This can lead to difficulty in maintaining fitness standards and limit their ability to fully function in performing their mission. In addition, this may lead to increased risk for chronic disease development. Few published studies exist that evaluate interventions aimed at weight loss and chronic disease prevention in the active duty population. The Group Lifestyle Balance (GLB) program has been shown to be effective in facilitating weight loss and reducing chronic disease risk in civilian populations. However, the effectiveness of this class in preventing chronic illnesses, facilitating weight loss, increasing physical activity and promoting perceptions of improved functioning and well-being has not been studied in active duty populations. The purpose of this study will be to examine the effectiveness of the GLB program compared with the currently available Fitness Improvement Program (FIP) and Better Body Better Life (BBBL) on the following health indicators: individual physical fitness as measured by change in weight, abdominal circumference and minutes engaged in physical activity; changes in risk associated with chronic disease as measured by changes in lipid and HbA1c levels; and changes in self-perception of function and well-being as measured by the RAND SF-36 questionnaire.
This will be a quantitative randomized control intervention study to determine the effects of a GLB class on physical indicators of fitness, disease risk and overall perception of functional health and well-being in an active duty population, and to compare outcomes with the FIP intervention (care as usual) and newly implemented BBBL intervention currently offered to Airmen. This study will be conducted at David Grant Medical Center (DGMC), Travis AFB, California.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• An active duty member of the USAF
Have at least one of the following conditions:
- An abdominal circumference over 35 inches for men or 31.5 inches for women
- BMI over 25 kg/m2
- Are willing to commit to weekly 1 hour classes for 12 weeks and monthly 1 hour classes for an additional 3 months
Exclusion Criteria:
• Women who are pregnant or breastfeeding
- Participants who are within 8 months of a Permanent Change of Station or deployment
- Anyone who has been restricted from participating in moderate activity equivalent to a brisk walk
- Taking lipid-lowering or glucose-lowering medication
- Anyone who for medical reasons cannot have a calorie-restricted diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group Lifestyle Balance
Participants receive the Group Lifestyle Balance intervention as per the standard curriculum
|
The content of the GLB program consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content.
Participants are also given information about increasing activity in their daily routines.
In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity.
GLB instructors function as lifestyle coaches for class participants.
They provide individual feedback and encouragement on documented eating and activity habits.
The instructors make themselves available to be contacted by participants outside of class to address participant concerns and issues as needed
Other Names:
|
Active Comparator: Better Body Better Life
Participants receive the Better Body Better Life intervention as per the standard curriculum
|
The BBBL program is an Air Force weight management program.).
It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals.
Each module is done in a classroom and is 2 hours long.
One module per week is offered.
Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class
Other Names:
|
Active Comparator: Fitness Improvement Program
Participants take the Fitness Improvement Program on-line
|
The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material.
The on-line FIP can be done all in one sitting or in segments.
There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer.
The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary.
Each section has a short video presentation.
The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals.
Participants are then responsible for using the information for their own self-directed program.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 6 months
|
measured on a calibrated human weight scale
|
6 months
|
Abdominal Circumference
Time Frame: measured at 6 months
|
measurement taken as per Air Force Instruction for the Fitness Assessment
|
measured at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Well-being
Time Frame: 6 months
|
as measured by the Rand SF 36 questionnaire.
Scores range from 0-100 with higher scores indicating greater well-being or function.
|
6 months
|
Lipids
Time Frame: 6 months
|
serum levels obtained through venipuncture
|
6 months
|
Physical Activity
Time Frame: 6 months
|
As measured by minutes per week of physical activity
|
6 months
|
HbA1C
Time Frame: 6 months
|
serum levels obtained through venipuncture
|
6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FDG20150017H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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