- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05074108
Mitigating and Preventing Disordered Eating in Transitioning Service Members
April 19, 2024 updated by: Uniformed Services University of the Health Sciences
Adapted Total Force Kitchen Pilot Intervention to Mitigate and Prevent Disordered Eating in Transitioning Service Members
Despite documented evidence of disordered eating (DE) among Active Duty (AD) Service Members (SM) and Veterans, DE has not been assessed in SM undergoing the transition from AD to Veterans status (AD-VS).
The objective of the current study is to explore gender differences and associations between nutrition knowledge, DE attitudes and behaviors, mental health, and military-specific experiences in women and men undergoing the AD-VS transition, and then use this information along with qualitative feedback from focus groups to inform adaptations of an existing nutrition education program for pilot testing in AD-VS women and men.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Despite documented evidence of disordered eating (DE) among Active Duty (AD) Service Members (SM) and Veterans, DE has not been assessed in SM undergoing the transition from AD to Veterans status (AD-VS).
DE describes psychologically-driven, subclinical, maladaptive eating behaviors that do not meet diagnostic criteria for eating disorders (ED), which are serious psychiatric conditions that require intensive medical intervention and treatment.
DE, while less clinically severe than ED, likely affects a much larger proportion of individuals and often goes unreported and/or underdiagnosed, thereby paving the way for chronic DE and development of deleterious outcomes.
Mental health is intimately connected with eating behaviors and associations between DE/ED and other mental comorbidities have been described in AD and Veteran populations.
By addressing DE during the AD-VS transition time, it may be possible to mitigate the long term clinical consequences that result from chronic DE.
The AD-VS time frame is an especially opportune time to intervene with health-focused interventions given the evidence of weight gain and reductions in physical activity that occurs following separation from AD service.
The contribution of DE behaviors to weight gain during and immediately following the AD-VS transition has not been explored and could be one factor to target in order to improve healthy lifestyle behaviors during this critical juncture.
Interventions that provide SM with resources and strategies to prevent or minimize DE behaviors and improve mental health early in the AD-VS transition process may help to prevent adverse outcomes for Veterans.
Based on the available evidence linking DE and mental health in Veterans, interventions that are able to address these issues holistically and prevent downstream clinical outcomes are worthy of investigation in AD-VS women and men.
Thus, the objective of the current study is to explore gender differences and associations between nutrition knowledge, DE attitudes and behaviors, mental health, and military-specific experiences in women and men undergoing the AD-VS transition, and then use this information along with qualitative feedback from focus groups to inform adaptations of an existing nutrition education program for pilot testing in AD-VS women and men.
Ultimately, this study is the first step in determining a strategy to attenuate the deleterious mental and physical health impacts of poor nutrition and DE in Veterans.
Study Type
Interventional
Phase
- 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.
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
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Current Active Duty Service Member in the process of transitioning (e.g. separating or retiring) from the military assigned to Naval Support Activity Bethesda
- Age ≥17 years old
- Read and write English
Exclusion Criteria:
- Self-reported current or recent (past 5 years) diagnosis of a Diagnostic and Statistical Manual- (DSM-5) eating disorder including: Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder AND/OR
- A score of ≥15 on the Eating Disorder Examination-Questionnaire Short (EDE-QS)
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilot study
Adapt and pilot a nutrition-based intervention.
The program will take a holistic approach to educate participants about basic nutrition and cooking skills, sleep, and mindfulness strategies to enhance mental health.
|
Aiming for an interaction 6 week course that will discuss many aspects of health and wellness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition knowledge
Time Frame: Pre and Post intervention, approximately 6 weeks apart
|
Scores on Abridged Nutrition for Sport Knowledge Questionnaire.
Questionnaire is 35 questions long.
Answers are scored as either correct or incorrect.
Scores range from 0-35, higher scores are more desirable and indicate greater nutrition knowledge.
|
Pre and Post intervention, approximately 6 weeks apart
|
|
Eating attitudes / behaviors
Time Frame: Pre and Post intervention, approximately 6 weeks apart
|
Scores on Eating Pathology Symptoms Inventory.
The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 45 items covering 8 subscales: Body Dissatisfaction, Binge Eating, Cognitive Restraint, Purging, Restricting, Excessive Exercise, Negative Attitudes toward Obesity, and Muscle Building.
Each item is scored on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences.
Scores are derived by summing responses across the questions included in each subscale.
Scores range from 0-180.
Lower scores are more desirable.
|
Pre and Post intervention, approximately 6 weeks apart
|
|
Eating attitudes / behaviors
Time Frame: Pre and Post intervention, approximately 6 weeks apart
|
Scores on Eating Disorder Examination-Questionnaire Short.
The Eating Disorder Examination - Questionnaire Short (EDE-QS) was developed as a 12-item version of the Eating Disorder Examination Questionnaire (EDE-Q) with a 4-point response scale that assesses eating disorder (ED) symptoms over the preceding 7 days.
Scores range from 0-36.
Lower scores are more desirable.
|
Pre and Post intervention, approximately 6 weeks apart
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan M Scott, PhD, Uniformed Services University of the Health Sciences
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 (Estimated)
January 1, 2022
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
August 9, 2021
First Submitted That Met QC Criteria
September 28, 2021
First Posted (Actual)
October 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MEM-91-12005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data generated under the funding award will be provided to the Military Women's Health Research Consortium and the Uniformed Services University, as requested in the Funding Opportunity Announcement.
More broadly, data will be shared in an aggregated form through abstracts and presentations submitted to research conferences and manuscripts written for publication in peer-reviewed scientific journals.
To protect the confidentiality of the participants, no data will ever be identified in publications/presentations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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