Prevention of Obesity in Military Communities - Fit4Duty (POMC-Fit4Duty)

Prevention of Obesity in Military Communities - Fit4Duty: Phase 2

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Adiposity
• Intervention / Treatment: Behavioral: Fit4Duty; Other: Nutrition Education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Uniformed Services University of the Health Sciences
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fit4Duty; 6-week weight gain prevention group	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.
ACTIVE_COMPARATOR: Nutrition Education; Two, 50 minute educational videos.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Oregon Research Institute; Madigan Army Medical Center
• Investigators: Principal Investigator: Tracy Sbrocco, PhD, Uniformed Services University of the Health Sciences; Principal Investigator: Douglas Maurer, DO, MPH, Madigan Army Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): December 27, 2016
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (ESTIMATE): February 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Prevention; Service Members; U.S. Military
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: F172NC-S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO