Primary Prevention
Conditions
Brief summary
With this study researchers will evaluate the effects of the GLB intervention on weight loss, chronic disease indicators and self-perceived function and well-being in an active duty population. The purpose of this study is to examine the effectiveness of the GLB program \[compared with two currently available programs, the Fitness Improvement Program (FIP) and the Better Body Better Life (BBBL) program\], on the following health indicators: improvement of individual physical fitness as measured by change in abdominal circumference, weight and physical activity; decrease in risk associated with chronic disease as measured by changes in lipid and HbA1c levels; and improvement in self-perceived function and well-being as measured by the RAND 36 Item Short Form Health Survey (RAND SF- 36). In addition, the researchers seek to obtain feedback about the programs from the participants.
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.
Interventions
BEHAVIORALGroup Lifestyle Balance
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
BEHAVIORALBetter Body Better Life
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
BEHAVIORALFitness Improvement Program
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.
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 6 months | measured on a calibrated human weight scale |
| Abdominal Circumference | measured at 6 months | measurement taken as per Air Force Instruction for the Fitness Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well-being | 6 months | as measured by the Rand SF 36 questionnaire. Scores range from 0-100 with higher scores indicating greater well-being or function. |
| Lipids | 6 months | serum levels obtained through venipuncture |
| Physical Activity | 6 months | As measured by minutes per week of physical activity |
| HbA1C | 6 months | serum levels obtained through venipuncture |
Participant flow
Recruitment details
Recruitment began August 2015 and ended April 2018. Participants were recruited through flyers table tents in the Medical Group clinics and cafeteria and email blasts through unit fitness monitors.
Pre-assignment details
Once participants were enrolled to the study, initial measurements (with the exception of lab work requiring blood draws) were taken before assignment to groups. The reason for this was to avoid bias on the part of the research team that might occur with knowledge of group assignment before obtaining initial data.
Participants by arm
| Arm | Count |
|---|---|
| Group Lifestyle Balance Participants receive the Group Lifestyle Balance intervention as per the standard curriculum
Group Lifestyle Balance: Content 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 | 30 |
| Better Body Better Life Participants receive the Better Body Better Life intervention as per the standard curriculum
Better Body Better Life: 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 | 23 |
| Fitness Improvement Program Participants take the Fitness Improvement Program on-line
Fitness Improvement Program: 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. | 30 |
| Total | 83 |
Baseline characteristics
| Characteristic | Fitness Improvement Program | Better Body Better Life | Group Lifestyle Balance | Total |
|---|---|---|---|---|
| abdominal circumference | 36.86 inches STANDARD_DEVIATION 4.02 | 36.49 inches STANDARD_DEVIATION 4.17 | 35.51 inches STANDARD_DEVIATION 3.63 | 36.30 inches STANDARD_DEVIATION 3.96 |
| Age, Continuous | 32.90 years STANDARD_DEVIATION 6.61 | 32.30 years STANDARD_DEVIATION 5.05 | 33.30 years STANDARD_DEVIATION 7.61 | 32.89 years STANDARD_DEVIATION 6.53 |
| hgbA1c | 5.24 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.47 | 5.28 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.24 | 5.33 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.36 | 5.28 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.36 |
| lipid HDL | 52 mg/dL | 54 mg/dL | 51 mg/dL | 52.19 mg/dL |
| lipid LDL | 92 mg/dL | 100 mg/dL | 111.8 mg/dL | 101.37 mg/dL |
| lipid Total Cholesterol | 176 mg/dL | 180.00 mg/dL | 187.5 mg/dL | 181.27 mg/dL |
| lipid Triglycerides | 84 mg/dL | 89 mg/dL | 92.5 mg/dL | 88.46 mg/dL |
| Race/Ethnicity, Customized African American | 5 Participants | 5 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Multiple/Other | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 13 Participants | 14 Participants | 43 Participants |
| Region of Enrollment United States | 42 participants | 40 participants | 40 participants | 122 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 12 Participants | 43 Participants |
| weight | 204.46 pounds STANDARD_DEVIATION 36.68 | 200.29 pounds STANDARD_DEVIATION 32.26 | 190.95 pounds STANDARD_DEVIATION 31.2 | 199.66 pounds STANDARD_DEVIATION 33.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 42 |
Outcome results
Primary
Abdominal Circumference
measurement taken as per Air Force Instruction for the Fitness Assessment
Time frame: measured at 6 months
Population: Abdominal circumference in inches at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | Abdominal Circumference | 34.96 inches | Standard Error 0.7 |
| Better Body Better Life | Abdominal Circumference | 35.68 inches | Standard Error 0.86 |
| Fitness Improvement Program | Abdominal Circumference | 36.09 inches | Standard Error 0.8 |
Primary
Weight
measured on a calibrated human weight scale
Time frame: 6 months
Population: Weight measurement in pounds at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | Weight | 191.47 pounds | Standard Error 5.39 |
| Better Body Better Life | Weight | 198.08 pounds | Standard Error 7.27 |
| Fitness Improvement Program | Weight | 204.08 pounds | Standard Error 7.24 |
Secondary
HbA1C
serum levels obtained through venipuncture
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | HbA1C | 5.26 percentage of glycosylated hemoglobin | Standard Deviation 0.43 |
| Better Body Better Life | HbA1C | 5.22 percentage of glycosylated hemoglobin | Standard Deviation 0.45 |
| Fitness Improvement Program | HbA1C | 5.26 percentage of glycosylated hemoglobin | Standard Deviation 0.4 |
Secondary
Lipids
serum levels obtained through venipuncture
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | Lipids | 188.17 total cholesterol mg/dL | Standard Deviation 34.59 |
| Better Body Better Life | Lipids | 180.52 total cholesterol mg/dL | Standard Deviation 36.15 |
| Fitness Improvement Program | Lipids | 170.67 total cholesterol mg/dL | Standard Deviation 31.73 |
Secondary
Physical Activity
As measured by minutes per week of physical activity
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | Physical Activity | 45 minutes per week | Standard Error 7.68 |
| Better Body Better Life | Physical Activity | 50 minutes per week | Standard Error 6.78 |
| Fitness Improvement Program | Physical Activity | 45 minutes per week | Standard Error 7.75 |
Secondary
Well-being
as measured by the Rand SF 36 questionnaire. Scores range from 0-100 with higher scores indicating greater well-being or function.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance | Well-being | 77 score on a scale | Standard Error 7.68 |
| Better Body Better Life | Well-being | 82 score on a scale | Standard Error 6.78 |
| Fitness Improvement Program | Well-being | 76 score on a scale | Standard Error 7.75 |