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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Lifestyle Balance | Active Comparator | Participants receive the Group Lifestyle Balance intervention as per the standard curriculum |
|
| Better Body Better Life | Active Comparator | Participants receive the Better Body Better Life intervention as per the standard curriculum |
|
| Fitness Improvement Program | Active Comparator | Participants take the Fitness Improvement Program on-line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Lifestyle Balance | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | measured on a calibrated human weight scale | 6 months |
| Abdominal Circumference | measurement taken as per Air Force Instruction for the Fitness Assessment | measured at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Well-being | 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 | serum levels obtained through venipuncture |
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Inclusion Criteria:
• An active duty member of the USAF
Have at least one of the following conditions:
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
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33657870 | Derived | Armitage NH, Kramer MK, Nelson MS, Hopkins D, Langeslay R, Thornton JA. Effectiveness of Lifestyle Interventions in an Active Duty Air Force Population. Am J Health Promot. 2021 Jul;35(6):784-793. doi: 10.1177/0890117121997308. Epub 2021 Mar 4. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data was changed from all enrollees to study completers to be consistent with numbers of participants included in outcome measure analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | measured on a calibrated human weight scale | Weight measurement in pounds at 6 months | Posted | Mean | Standard Error | pounds | 6 months |
|
Adverse event data were collected for approximately 6 months for each participant. Data were collected from the time participants started the study until they completed data collection at the 6 month time frame.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Col Nicole Armitage | 711 Human Performance Wing, U.S. Air Force | 937-255-3784 | nicole.armitage@us.af.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol and statistical analysis plan | Jan 27, 2017 | Jun 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2017 | Jul 9, 2020 | ICF_001.pdf |
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|
|
| Better Body Better Life | Behavioral | 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 |
|
|
| Fitness Improvement Program | Behavioral | 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. |
|
|
| 6 months |
| Physical Activity | As measured by minutes per week of physical activity | 6 months |
| HbA1C | serum levels obtained through venipuncture | 6 months |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | pounds |
|
| abdominal circumference | Mean | Standard Deviation | inches |
|
| lipid | Mean | Full Range | mg/dL |
|
| hgbA1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| OG001 | 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 |
| OG002 | 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. |
|
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| Primary | Abdominal Circumference | measurement taken as per Air Force Instruction for the Fitness Assessment | Abdominal circumference in inches at 6 months | Posted | Mean | Standard Error | inches | measured at 6 months |
|
|
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| 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. | Posted | Mean | Standard Error | score on a scale | 6 months |
|
|
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| Secondary | Lipids | serum levels obtained through venipuncture | Posted | Mean | Standard Deviation | total cholesterol mg/dL | 6 months |
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| Secondary | Physical Activity | As measured by minutes per week of physical activity | Posted | Median | Standard Error | minutes per week | 6 months |
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| Secondary | HbA1C | serum levels obtained through venipuncture | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 6 months |
|
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
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