Prevention of Obesity in Military Communities - Fit4Duty (POMC-Fit4Duty)
Primary Purpose
Obesity, Overweight, Adiposity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit4Duty
Nutrition Education
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring U.S. Military, Overweight, Obesity, Service Members, Prevention
Eligibility 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
Sites / Locations
- Uniformed Services University of the Health Sciences
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fit4Duty
Nutrition Education
Arm Description
6-week weight gain prevention group
Two, 50 minute educational videos.
Outcomes
Primary Outcome Measures
Participant weight (lbs)
Participants will be weighed using professional grade equipment and trained personnel
Secondary Outcome Measures
Body Composition: body fat %
Participants' body composition will be determined using professional grade equipment and trained personnel
Abdominal waist and hip circumference
Participants will be measured using a cloth tape measure with a spring-loaded handle
Full Information
NCT ID
NCT02679937
First Posted
February 4, 2016
Last Updated
February 22, 2018
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Madigan Army Medical Center, Oregon Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02679937
Brief Title
Prevention of Obesity in Military Communities - Fit4Duty
Acronym
POMC-Fit4Duty
Official Title
Prevention of Obesity in Military Communities - Fit4Duty: Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 27, 2016 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Madigan Army Medical Center, Oregon Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Adiposity
Keywords
U.S. Military, Overweight, Obesity, Service Members, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fit4Duty
Arm Type
Experimental
Arm Description
6-week weight gain prevention group
Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
Two, 50 minute educational videos.
Intervention Type
Behavioral
Intervention Name(s)
Fit4Duty
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition Education
Intervention Description
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 Measure Information:
Title
Participant weight (lbs)
Description
Participants will be weighed using professional grade equipment and trained personnel
Time Frame
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
Secondary Outcome Measure Information:
Title
Body Composition: body fat %
Description
Participants' body composition will be determined using professional grade equipment and trained personnel
Time Frame
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
Title
Abdominal waist and hip circumference
Description
Participants will be measured using a cloth tape measure with a spring-loaded handle
Time Frame
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Sbrocco, PhD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Maurer, DO, MPH
Organizational Affiliation
Madigan Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Obesity in Military Communities - Fit4Duty
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