Prevention of Obesity in Military Communities - Fit4Duty

NCT02679937 | Completed DMC

• 1 other identifier: F172NC-S1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity; Overweight; Adiposity

Keywords

U.S. Military; Overweight; Obesity; Service Members; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body Composition: body fat %

  Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years

• Abdominal waist and hip circumference

  Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years

Study Arms (2)

Fit4Duty

EXPERIMENTAL

6-week weight gain prevention group

Behavioral: Fit4Duty

Nutrition Education

ACTIVE COMPARATOR

Two, 50 minute educational videos.

Other: Nutrition Education

Interventions

Fit4Duty BEHAVIORAL

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.

Fit4Duty

Nutrition Education OTHER

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.

Nutrition Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active Duty Service Member
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Madigan Army Medical Center: collaborator
• Oregon Research Institute: collaborator

Study Sites (2)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Tracy Sbrocco, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Douglas Maurer, DO, MPH

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 11, 2016
• Study Start: June 1, 2014
• Primary Completion: December 27, 2016
• Study Completion: September 30, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)