Diet, Food, and NutritionNCT05074108
Mitigating and Preventing Disordered Eating in Transitioning Service Members
A study testing Pilot study in people with Diet, Food, and Nutrition and Healthy Eating, run by Uniformed Services University of the Health Sciences.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Food, and Nutrition, Healthy Eating, Eating Habit
- What is being tested?
- Pilot study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet, Food, and Nutrition, Healthy Eating, Eating Habit, Mindfulness
- Being tested
- Pilot study
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot studyBehavioural
Aiming for an interaction 6 week course that will discuss many aspects of health and wellness.
| Study group | Role | What they receive |
|---|---|---|
| Pilot study | Experimental | 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. Receives: Behavioral: Pilot study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition knowledge
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.
Measured: Pre and Post intervention, approximately 6 weeks apart
Eating attitudes / behaviors
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.
Measured: Pre and Post intervention, approximately 6 weeks apart
Eating attitudes / behaviors
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.
Measured: Pre and Post intervention, approximately 6 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Food, and NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- VA Connecticut Healthcare System, Yale University
- Responsible party
- Sponsor
- Investigators
- Jonathan M Scott, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074108
- Sponsor's protocol ID
- MEM-91-12005
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Total Force Kitchen Pilot Intervention to Mitigate and Prevent Disordered Eating in Transitioning Service Members
- ClinicalTrials.gov ID
- NCT05074108
- Acronym / sponsor ID
- MEM-91-12005
- Conditions
- Diet, Food, and Nutrition, Healthy Eating, Eating Habit, Mindfulness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- VA Connecticut Healthcare System, Yale University
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot study | Experimental | Behavioral: Pilot studyAdapt 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot studyAiming for an interaction 6 week course that will discuss many aspects of health and wellness. | Behavioural | Pilot study |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M Scott, PhD principal investigator
Uniformed Services University of the Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Pilot study in people with Diet, Food, and Nutrition and Healthy Eating, run by Uniformed Services University of the Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition knowledge (time frame: Pre and Post intervention, approximately 6 weeks apart). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.