Prevention of Obesity in Military Communities - Fit4Duty

Obesity Clinical Trial

— POMC-Fit4Duty  

Official title:

Prevention of Obesity in Military Communities - Fit4Duty: Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679937
• Other study ID #: F172NC-S1
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 22, 2018
• Start date: June 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2018
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based, weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among military service members at-risk for obesity. The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health, which reduced obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition education control condition and is hypothesized to reduce excess weight gain beyond the control comparison program during the 2 year period following study participation.

Description:

Obesity is prevalent in military personnel and raises concerns related to health, readiness, and national defense. Adverse health consequences of obesity place military personnel at risk for serious medical problems while in the service and upon discharge/retirement. Additionally, failure to "make weight" may negatively impact one's military career and can lead to discharge from the service. Early identification of personnel at risk and implementation of prevention strategies are critical to addressing the problem of overweight in the military and are essential to maintaining a fit fighting force. The goal of this study is to test the effectiveness of a dissonance-based, weight-gain prevention program (Fit4Duty) to prevent excess weight gain among service members at risk for obesity due to a personal and/or family history of overweight. The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health. The program utilizes dissonance based, participant-driven group counseling to address the excess consumption of unhealthy foods and sedentary behavior. Active duty service members will be randomized to the Fit4Duty weight gain prevention program or a Nutrition Education comparison condition. Participants will complete height, weight, and body composition measurements, and self-report instruments at baseline, immediately following the prevention program (6-weeks), and one and two year follow-ups. It is hypothesized that Project Fit4Duty will result in significantly greater reduction in risk for increases in BMI percentile and percent fat mass, and risk for onset of overweight and obesity during the 2-year follow-up relative to a nutrition education control program. If successful, Project Fit4Duty would offer an economical approach for widespread obesity prevention in the U.S. Military.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 30, 2017
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active Duty Service Member

• 18.5 kg/m2 < BMI = 32kg/m2

• At risk for excess weight gain due to personal and/or family history of overweight

• English speaking

• Ability to complete study procedures

Exclusion Criteria:

• Presence of a major, chronic medical illness

• Illness and/or treatment likely to affect appetite or body weight

• Planned deployment/ training during the intervention period (upcoming 2 months)

• Documented or self-reported current pregnancy, current breast-feeding, or recently pregnant women (within 1 year of delivery). Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study

• Evidence or signs of suicidal ideation as determined by the research team

Related Conditions & MeSH terms

• Adiposity
• Obesity
• Overweight

Intervention

Behavioral:
• Fit4Duty
Small (<9) participant-driven groups meet weekly for 6, 1 hour sessions. Participants design small, gradual healthy lifestyle change plans with added verbal, written, and behavioral exercises designed to elicit dissonance regarding engaging in unhealthy eating and sedentary practices. Participants are asked to voluntarily discuss the health, interpersonal and societal costs of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of leanness, a healthy diet, and regular physical activity.

Other:
• Nutrition Education
Two, 50 minute educational videos address basic concepts of healthy nutrition and weight management reviewing topics such as macro and micronutrients, the virtue of whole grains, fruit, vegetables and superfoods, the dangers of dehydration and vitamin deficiency. The role of poor eating habits, lack of exercise and cultural and technological issues in America's obesity epidemic is examined. A basic understanding of energy balance is conveyed. The role of nutritional supplements is addressed.

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Madigan Army Medical Center, Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant weight (lbs)	Participants will be weighed using professional grade equipment and trained personnel	Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
Secondary	Body Composition: body fat %	Participants' body composition will be determined using professional grade equipment and trained personnel	Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
Secondary	Abdominal waist and hip circumference	Participants will be measured using a cloth tape measure with a spring-loaded handle	Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years