Clinical trial NCT02556112: Effectiveness of a Group Lifestyle Balance Class in a Military Population
Official title: Effectiveness of a Group Lifestyle Balance Class in a Military Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2015-09-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Weight
timeFrame: 6 months
measure: Abdominal Circumference
timeFrame: measured at 6 months
Secondary outcomes:
measure: Well-being
timeFrame: 6 months
measure: Lipids
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: HbA1C
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.