Trial Outcomes & Findings for Effectiveness of a Group Lifestyle Balance Class in a Military Population (NCT NCT02556112)
NCT ID: NCT02556112
Last Updated: 2020-07-15
Results Overview
measured on a calibrated human weight scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
6 months
Results posted on
2020-07-15
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
42
|
|
Overall Study
COMPLETED
|
30
|
23
|
30
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of a Group Lifestyle Balance Class in a Military Population
Baseline characteristics by cohort
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.30 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
32.30 years
STANDARD_DEVIATION 5.05 • n=7 Participants
|
32.90 years
STANDARD_DEVIATION 6.61 • n=5 Participants
|
32.89 years
STANDARD_DEVIATION 6.53 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple/Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
42 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
weight
|
190.95 pounds
STANDARD_DEVIATION 31.20 • n=5 Participants
|
200.29 pounds
STANDARD_DEVIATION 32.26 • n=7 Participants
|
204.46 pounds
STANDARD_DEVIATION 36.68 • n=5 Participants
|
199.66 pounds
STANDARD_DEVIATION 33.72 • n=4 Participants
|
|
abdominal circumference
|
35.51 inches
STANDARD_DEVIATION 3.63 • n=5 Participants
|
36.49 inches
STANDARD_DEVIATION 4.17 • n=7 Participants
|
36.86 inches
STANDARD_DEVIATION 4.02 • n=5 Participants
|
36.30 inches
STANDARD_DEVIATION 3.96 • n=4 Participants
|
|
lipid
Total Cholesterol
|
187.5 mg/dL
n=5 Participants
|
180.00 mg/dL
n=7 Participants
|
176 mg/dL
n=5 Participants
|
181.27 mg/dL
n=4 Participants
|
|
lipid
HDL
|
51 mg/dL
n=5 Participants
|
54 mg/dL
n=7 Participants
|
52 mg/dL
n=5 Participants
|
52.19 mg/dL
n=4 Participants
|
|
lipid
LDL
|
111.8 mg/dL
n=5 Participants
|
100 mg/dL
n=7 Participants
|
92 mg/dL
n=5 Participants
|
101.37 mg/dL
n=4 Participants
|
|
lipid
Triglycerides
|
92.5 mg/dL
n=5 Participants
|
89 mg/dL
n=7 Participants
|
84 mg/dL
n=5 Participants
|
88.46 mg/dL
n=4 Participants
|
|
hgbA1c
|
5.33 percentage of glycosylated hemoglobin
STANDARD_DEVIATION .36 • n=5 Participants
|
5.28 percentage of glycosylated hemoglobin
STANDARD_DEVIATION .24 • n=7 Participants
|
5.24 percentage of glycosylated hemoglobin
STANDARD_DEVIATION .47 • n=5 Participants
|
5.28 percentage of glycosylated hemoglobin
STANDARD_DEVIATION .36 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Weight measurement in pounds at 6 months
measured on a calibrated human weight scale
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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.
|
|---|---|---|---|
|
Weight
|
191.47 pounds
Standard Error 5.39
|
198.08 pounds
Standard Error 7.27
|
204.08 pounds
Standard Error 7.24
|
PRIMARY outcome
Timeframe: measured at 6 monthsPopulation: Abdominal circumference in inches at 6 months
measurement taken as per Air Force Instruction for the Fitness Assessment
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=30 Participants
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
|
Fitness Improvement Program
n=23 Participants
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.
|
|---|---|---|---|
|
Abdominal Circumference
|
34.96 inches
Standard Error .70
|
35.68 inches
Standard Error .86
|
36.09 inches
Standard Error .80
|
SECONDARY outcome
Timeframe: 6 monthsas measured by the Rand SF 36 questionnaire. Scores range from 0-100 with higher scores indicating greater well-being or function.
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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.
|
|---|---|---|---|
|
Well-being
|
77 score on a scale
Standard Error 7.68
|
82 score on a scale
Standard Error 6.78
|
76 score on a scale
Standard Error 7.75
|
SECONDARY outcome
Timeframe: 6 monthsserum levels obtained through venipuncture
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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.
|
|---|---|---|---|
|
Lipids
|
188.17 total cholesterol mg/dL
Standard Deviation 34.59
|
180.52 total cholesterol mg/dL
Standard Deviation 36.15
|
170.67 total cholesterol mg/dL
Standard Deviation 31.73
|
SECONDARY outcome
Timeframe: 6 monthsAs measured by minutes per week of physical activity
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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.
|
|---|---|---|---|
|
Physical Activity
|
45 minutes per week
Standard Error 7.68
|
50 minutes per week
Standard Error 6.78
|
45 minutes per week
Standard Error 7.75
|
SECONDARY outcome
Timeframe: 6 monthsserum levels obtained through venipuncture
Outcome measures
| Measure |
Group Lifestyle Balance
n=30 Participants
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
|
Better Body Better Life
n=23 Participants
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
|
Fitness Improvement Program
n=30 Participants
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.
|
|---|---|---|---|
|
HbA1C
|
5.26 percentage of glycosylated hemoglobin
Standard Deviation .43
|
5.22 percentage of glycosylated hemoglobin
Standard Deviation .45
|
5.26 percentage of glycosylated hemoglobin
Standard Deviation .40
|
Adverse Events
Group Lifestyle Balance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Better Body Better Life
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fitness Improvement Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Col Nicole Armitage
711 Human Performance Wing, U.S. Air Force
Phone: 937-255-3784
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place