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Effectiveness of a Group Lifestyle Balance Class in a Military Population

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ClinicalTrials.gov Identifier: NCT02556112
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2015
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nicole Armitage, David Grant U.S. Air Force Medical Center

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 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
Study Start Date : August 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

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 Name: 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 Name: 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 Name: BE WELL




Primary Outcome Measures :
  1. change in weight [ Time Frame: measured at baseline, 3 months and 6 months ]
    measured on standardized scale

  2. change in abdominal circumference [ Time Frame: measured at baseline and 6 months ]
    measurement taken as per Air Force Instruction for the Fitness Assessment

  3. change in HbA1C [ Time Frame: measured at baseline and 6 months ]
    serum levels obtained through venipuncture

  4. lipids [ Time Frame: measured at baseline and 6 months ]
    serum levels obtained through venipuncture

  5. well-being [ Time Frame: measured at baseline and 6 months ]
    as measured by the Rand SF 36 questionnaire

  6. physical activity [ Time Frame: measured at baseline and 6 months ]
    As measured by minutes per week of physical activity


Secondary Outcome Measures :
  1. Participant evaluation of interventions [ Time Frame: 6 months ]
    measured by open-ended questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Nicole Armitage, Chief, Clinical Investigations, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT02556112     History of Changes
Other Study ID Numbers: FDG20150017H
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No