Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679937
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Madigan Army Medical Center
Oregon Research Institute
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Adiposity Behavioral: Fit4Duty Other: Nutrition Education Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Obesity in Military Communities - Fit4Duty: Phase 2
Study Start Date : June 2014
Actual Primary Completion Date : December 27, 2016
Actual Study Completion Date : September 30, 2017

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.




Primary Outcome Measures :
  1. Participant weight (lbs) [ Time Frame: Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years ]
    Participants will be weighed using professional grade equipment and trained personnel


Secondary Outcome Measures :
  1. Body Composition: body fat % [ Time Frame: Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years ]
    Participants' body composition will be determined using professional grade equipment and trained personnel

  2. Abdominal waist and hip circumference [ Time Frame: Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years ]
    Participants will be measured using a cloth tape measure with a spring-loaded handle



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679937


Locations
Layout table for location information
United States, Maryland
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Madigan Army Medical Center
Oregon Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Tracy Sbrocco, PhD Uniformed Services University of the Health Sciences
Principal Investigator: Douglas Maurer, DO, MPH Madigan Army Medical Center
Layout table for additonal information
Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT02679937    
Other Study ID Numbers: F172NC-S1
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
U.S. Military
Overweight
Obesity
Service Members
Prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight