Effectiveness of a Group Lifestyle Balance Class in a Military Population

• Sponsor: David Grant U.S. Air Force Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02556112
• Collaborator: (none)
• Enrollment: 122
• Arms: 3
• Actual Duration (Months): 38.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention	Behavioral: Group Lifestyle Balance; Behavioral: Better Body Better Life; Behavioral: Fitness Improvement Program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness of a Group Lifestyle Balance Class in a Military Population
• Actual Study Start Date: Aug 11, 2015
• Actual Primary Completion Date: Oct 17, 2018
• Actual Study Completion Date: Oct 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Lifestyle Balance Participants receive the Group Lifestyle Balance intervention as per the standard curriculum	Behavioral: Group 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; Other Names: GLB
Active Comparator: Better Body Better Life Participants receive the Better Body Better Life intervention as per the standard curriculum	Behavioral: 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; Other Names: BBBL
Active Comparator: Fitness Improvement Program Participants take the Fitness Improvement Program on-line	Behavioral: 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.; Other Names: BE WELL

Outcome Measures

Primary Outcome Measures

1. Weight [6 months]

   measured on a calibrated human weight scale

2. Abdominal Circumference [measured at 6 months]

   measurement taken as per Air Force Instruction for the Fitness Assessment

Secondary Outcome Measures

1. 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.

2. Lipids [6 months]

   serum levels obtained through venipuncture

3. Physical Activity [6 months]

   As measured by minutes per week of physical activity

4. HbA1C [6 months]

   serum levels obtained through venipuncture

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• David Grant U.S. Air Force Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: Protocol and statistical analysis plan - Jan 27, 2017
• Informed Consent Form - Dec 12, 2017

More Information

Publications

None provided.

• Responsible Party: Nicole Armitage, Chief, Clinical Investigations, David Grant U.S. Air Force Medical Center
• ClinicalTrials.gov Identifier: NCT02556112
• Other Study ID Numbers: FDG20150017H
• First Posted: Sep 22, 2015
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

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 Detail	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.

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	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	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	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.
Period Title: Overall Study
STARTED	40	40	42
COMPLETED	30	23	30
NOT COMPLETED	10	17	12

Baseline Characteristics

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program	Total
Arm/Group Description	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	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	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.	Total of all reporting groups
Overall Participants	30	23	30	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.30 (7.61)	32.30 (5.05)	32.90 (6.61)	32.89 (6.53)
Sex: Female, Male (Count of Participants)
Female	18 60%	9 39.1%	13 43.3%	40 48.2%
Male	12 40%	14 60.9%	17 56.7%	43 51.8%
Race/Ethnicity, Customized (Count of Participants)
White	14 46.7%	13 56.5%	16 53.3%	43 51.8%
African American	9 30%	5 21.7%	5 16.7%	19 22.9%
Hispanic/Latino	5 16.7%	3 13%	4 13.3%	12 14.5%
Asian	1 3.3%	2 8.7%	3 10%	6 7.2%
Multiple/Other	1 3.3%	0 0%	2 6.7%	3 3.6%
Region of Enrollment (participants) [Number]
United States	40 133.3%	40 173.9%	42 140%	122 147%
weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	190.95 (31.20)	200.29 (32.26)	204.46 (36.68)	199.66 (33.72)
abdominal circumference (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	35.51 (3.63)	36.49 (4.17)	36.86 (4.02)	36.30 (3.96)
lipid (mg/dL) [Mean (Full Range) ]
Total Cholesterol	187.5	180.00	176	181.27
HDL	51	54	52	52.19
LDL	111.8	100	92	101.37
Triglycerides	92.5	89	84	88.46
hgbA1c (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	5.33 (.36)	5.28 (.24)	5.24 (.47)	5.28 (.36)

Outcome Measures

1. Primary Outcome

Title	Weight
Description	measured on a calibrated human weight scale
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Weight measurement in pounds at 6 months

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	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	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	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.
Measure Participants	30	23	30
Mean (Standard Error) [pounds]	191.47 (5.39)	198.08 (7.27)	204.08 (7.24)

2. Primary Outcome

Title	Abdominal Circumference
Description	measurement taken as per Air Force Instruction for the Fitness Assessment
Time Frame	measured at 6 months

Outcome Measure Data

Analysis Population Description

Abdominal circumference in inches at 6 months

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	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	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	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.
Measure Participants	30	30	23
Mean (Standard Error) [inches]	34.96 (.70)	35.68 (.86)	36.09 (.80)

3. Secondary Outcome

Title	Well-being
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	Participants receive the Group Lifestyle Balance intervention as per the standard curriculum Group 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.	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	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.
Measure Participants	30	23	30
Mean (Standard Error) [score on a scale]	77 (7.68)	82 (6.78)	76 (7.75)

4. Secondary Outcome

Title	Lipids
Description	serum levels obtained through venipuncture
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	Participants receive the Group Lifestyle Balance intervention as per the standard curriculum Group 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.	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	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.
Measure Participants	30	23	30
Mean (Standard Deviation) [total cholesterol mg/dL]	188.17 (34.59)	180.52 (36.15)	170.67 (31.73)

5. Secondary Outcome

Title	Physical Activity
Description	As measured by minutes per week of physical activity
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	Participants receive the Group Lifestyle Balance intervention as per the standard curriculum Group 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.	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	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.
Measure Participants	30	23	30
Median (Standard Error) [minutes per week]	45 (7.68)	50 (6.78)	45 (7.75)

6. Secondary Outcome

Title	HbA1C
Description	serum levels obtained through venipuncture
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Lifestyle Balance	Better Body Better Life	Fitness Improvement Program
Arm/Group Description	Participants receive the Group Lifestyle Balance intervention as per the standard curriculum Group 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.	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	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.
Measure Participants	30	23	30
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	5.26 (.43)	5.22 (.45)	5.26 (.40)

Adverse Events

Time Frame	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.
Arm/Group Title	Group Lifestyle Balance		Better Body Better Life		Fitness Improvement Program
Arm/Group Description	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		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		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.
All Cause Mortality
	Group Lifestyle Balance		Better Body Better Life		Fitness Improvement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)
Serious Adverse Events
	Group Lifestyle Balance		Better Body Better Life		Fitness Improvement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Group Lifestyle Balance		Better Body Better Life		Fitness Improvement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.