NCT02556112

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

September 15, 2015

Results QC Date

May 12, 2020

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Weight

    measured on a calibrated human weight scale

    6 months

  • Abdominal Circumference

    measurement taken as per Air Force Instruction for the Fitness Assessment

    measured at 6 months

Secondary Outcomes (4)

  • Well-being

    6 months

  • Lipids

    6 months

  • Physical Activity

    6 months

  • HbA1C

    6 months

Study Arms (3)

Group Lifestyle Balance

ACTIVE COMPARATOR

Participants receive the Group Lifestyle Balance intervention as per the standard curriculum

Behavioral: Group Lifestyle Balance

Better Body Better Life

ACTIVE COMPARATOR

Participants receive the Better Body Better Life intervention as per the standard curriculum

Behavioral: Better Body Better Life

Fitness Improvement Program

ACTIVE COMPARATOR

Participants take the Fitness Improvement Program on-line

Behavioral: Fitness Improvement Program

Interventions

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

Also known as: GLB
Group Lifestyle Balance

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

Also known as: BBBL
Better Body Better Life

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.

Also known as: BE WELL
Fitness Improvement Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Results Point of Contact

Title
Col Nicole Armitage
Organization
711 Human Performance Wing, U.S. Air Force

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Clinical Investigations

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 22, 2015

Study Start

August 11, 2015

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

July 15, 2020

Results First Posted

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share