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

February 22, 2018 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years
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
Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oregon Research Institute
Madigan Army Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F172NC-S1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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