Primary PreventionNCT02556112
Effectiveness of a Group Lifestyle Balance Class in a Military Population
A study testing Group Lifestyle Balance, Better Body Better Life and Fitness Improvement Program in people with Primary Prevention, run by David Grant U.S. Air Force Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Group Lifestyle Balance, Better Body Better Life and Fitness Improvement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2015to 17 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
About this study
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.
Read the 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.
- Conditions
- Primary Prevention
- Being tested
- Group Lifestyle Balance, Better Body Better Life, Fitness Improvement Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Lifestyle BalanceBehavioural
Also called GLB
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
Better Body Better LifeBehavioural
Also called BBBL
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 ProgramBehavioural
Also called BE WELL
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Lifestyle Balance | Active comparator | Participants receive the Group Lifestyle Balance intervention as per the standard curriculum Receives: Behavioral: Group Lifestyle Balance |
| Better Body Better Life | Active comparator | Participants receive the Better Body Better Life intervention as per the standard curriculum Receives: Behavioral: Better Body Better Life |
| Fitness Improvement Program | Active comparator | Participants take the Fitness Improvement Program on-line Receives: Behavioral: Fitness Improvement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
measured on a calibrated human weight scale
Measured: 6 months
Abdominal Circumference
measurement taken as per Air Force Instruction for the Fitness Assessment
Measured: measured at 6 months
Secondary outcomes (4)
Well-being
as measured by the Rand SF 36 questionnaire. Scores range from 0-100 with higher scores indicating greater well-being or function.
Measured: 6 months
Lipids
serum levels obtained through venipuncture
Measured: 6 months
Physical Activity
As measured by minutes per week of physical activity
Measured: 6 months
HbA1C
serum levels obtained through venipuncture
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start11 Aug 2015
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nicole Armitage, David Grant U.S. Air Force Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556112
- Sponsor's protocol ID
- FDG20150017H
- Status last verified
- Jul 2020
- First submitted
- 15 Sep 2015
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33657870
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Group Lifestyle Balance Class in a Military Population
- ClinicalTrials.gov ID
- NCT02556112
- Acronym / sponsor ID
- FDG20150017H
- Conditions
- Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 11 Aug 2015 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Lifestyle Balance | Active comparator | Behavioral: Group Lifestyle BalanceParticipants receive the Group Lifestyle Balance intervention as per the standard curriculum |
| Better Body Better Life | Active comparator | Behavioral: Better Body Better LifeParticipants receive the Better Body Better Life intervention as per the standard curriculum |
| Fitness Improvement Program | Active comparator | Behavioral: Fitness Improvement ProgramParticipants take the Fitness Improvement Program on-line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • An active duty member of the USAF
Key exclusion criteria (5 listed)
- • Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Lifestyle BalanceAlso: GLBThe 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 | Behavioural | Group Lifestyle Balance |
| Better Body Better LifeAlso: BBBLThe 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 | Behavioural | Better Body Better Life |
| Fitness Improvement ProgramAlso: BE WELLThe 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. | Behavioural | Fitness Improvement Program |
Primary outcome
Weight
Time frame: 6 months
measured on a calibrated human weight scale
Abdominal Circumference
Time frame: measured at 6 months
measurement taken as per Air Force Instruction for the Fitness Assessment
4 secondary outcomes
Well-being
Time frame: 6 months
Lipids
Time frame: 6 months
Physical Activity
Time frame: 6 months
HbA1C
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33657870Armitage 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group Lifestyle Balance, Better Body Better Life and Fitness Improvement Program in people with Primary Prevention, run by David Grant U.S. Air Force Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.