NCT02556112

Effectiveness of a Group Lifestyle Balance Class in a Military Population

Completed NA Results posted Last updated 15 July 2020

What this trial tests

NA trial testing Group Lifestyle Balance in Primary Prevention in 122 participants. Completed in 17 October 2018.

Timeline

11 August 2015

Primary endpoint
17 October 2018

17 October 2018

Quick facts

Lead sponsor	David Grant U.S. Air Force Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	122
Start date	11 August 2015
Primary completion	17 October 2018
Estimated completion	17 October 2018

Drugs / interventions tested

• Group Lifestyle Balance
• Better Body Better Life
• Fitness Improvement Program

Conditions studied

• Primary Prevention — all drugs for Primary Prevention →

Sponsor

David Grant U.S. Air Force Medical Center

Who can join

18 and older, any sex, with Primary Prevention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Primary · 6 months

measured on a calibrated human weight scale

Group	Value	95% CI
Group Lifestyle Balance	191.47	± 5.39
Better Body Better Life	198.08	± 7.27
Fitness Improvement Program	204.08	± 7.24

Abdominal Circumference Primary · measured at 6 months

measurement taken as per Air Force Instruction for the Fitness Assessment

Group	Value	95% CI
Group Lifestyle Balance	34.96	± .70
Better Body Better Life	35.68	± .86
Fitness Improvement Program	36.09	± .80

Well-being Secondary · 6 months

as measured by the Rand SF 36 questionnaire. Scores range from 0-100 with higher scores indicating greater well-being or function.

Group	Value	95% CI
Group Lifestyle Balance	77	± 7.68
Better Body Better Life	82	± 6.78
Fitness Improvement Program	76	± 7.75

Lipids Secondary · 6 months

serum levels obtained through venipuncture

Group	Value	95% CI
Group Lifestyle Balance	188.17	± 34.59
Better Body Better Life	180.52	± 36.15
Fitness Improvement Program	170.67	± 31.73

Physical Activity Secondary · 6 months

As measured by minutes per week of physical activity

Group	Value	95% CI
Group Lifestyle Balance	45	± 7.68
Better Body Better Life	50	± 6.78
Fitness Improvement Program	45	± 7.75

HbA1C Secondary · 6 months

serum levels obtained through venipuncture

Group	Value	95% CI
Group Lifestyle Balance	5.26	± .43
Better Body Better Life	5.22	± .45
Fitness Improvement Program	5.26	± .40

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.