- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810403
SOMEBODY, a Social Media-based Eating Disorder Prevention Program
May 3, 2022 updated by: Pamela Keel, Florida State University
An Open Trial Pilot Study of SOMEBODY, a Social Media-based Eating Disorder Prevention Program for College Women
The purpose of this study is to develop and evaluate the feasibility, acceptability, and preliminary evidence of potential efficacy of a social-media based intervention to reduce risk factors for eating disorders in college women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous research supports an association between specific aspects of social media use and increased eating pathology in correlational designs and that specific aspects of social media use cause increases in risk factors for eating disorders.
The aim of the current project is to determine whether social media use can be altered to cause decreases in eating disorder risk factors.
To accomplish this, college women will be recruited to participate in an open trial of a pilot program that adapts activities used within evidence-based eating disorder prevention programs to be used on social media platforms.
The intervention is designed to target internalization of the thin ideal.
Study Type
Interventional
Enrollment (Actual)
8
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.
Study Locations
-
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Florida
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Tallahassee, Florida, United States, 32304
- Florida State University Psychology Department
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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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female
- 18 to 25 years old
- score in the top 50th percentile for time spent on social media each day
Exclusion Criteria:
- male
- <18 years or >25 years old
- individuals who screen positive for a Diagnostic Statistical Manual-5 eating disorder on the Eating Disorder Diagnostic Scale
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: SOMEBODY Eating Disorder Prevention Program
All participants will be recruited to participate in the SOcial MEdia (SOME) adaptation of activities from the BODY Project (SOMEBODY).
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Participants will receive daily activities to complete on their most frequently used social media platform for 14 consecutive days.
Daily activities have been adapted from the Body Project - an intervention that has been demonstrated to reduce internalization of the thin ideal and reduce risk for eating disorders.
Examples of activities to be piloted include unfollowing social media accounts the participant perceives as reinforcing the thin-ideal and posting a selfie without makeup or editing.
Based on feedback from participants, the intervention may be altered to improve acceptability, feasibility, and preliminary evidence of potential efficacy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of intervention
Time Frame: 2 weeks
|
Acceptability will be evaluated with 7-point Likert scale ratings, with a score ≥5 indicating that participants found the intervention acceptable
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2 weeks
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Feasibility of intervention
Time Frame: 2 weeks
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Feasibility will be evaluated as the percentage of consented and enrolled participants who complete ≥10 of the 14 days of the intervention, with ≥80% indicating feasibility
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2 weeks
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Change in internalization of the thin ideal
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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The Sociocultural Attitudes Towards Appearance Questionnaire - 4 Revised (SATAQ-4R) Internalization Subscales will be used to measure internationalization of the thin ideal before and after the intervention.
An effect size of d=.50 for within subject change in score will establish preliminary evidence of potential efficacy
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body image concerns
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
|
The Eating Disorders Examination Questionnaire Weight and Shape Concerns subscales adapted for the past 7 days will be used to measure change in body image before and after the intervention
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Change in dietary restraint
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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The Eating Disorders Examination Questionnaire Dietary Restraint subscale adapted for the past 7 days will be used to measure change in dietary restraint before and after the intervention
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Change in bulimic symptoms
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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The Eating Disorders Examination Questionnaire Self-Reported Bulimic Symptom Composite Score adapted for the past 7 days will be used to measure change in bulimic symptom frequency before and after the intervention
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Change in disordered eating
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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The Eating Disorders Examination Questionnaire Global Score adapted for the past 7 days will be used to measure change in disordered eating before and after the intervention
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Change in social media use
Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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The Social Media Use Questionnaire items assessing frequency and type of engagement with social media will be used to measure change in social media use before and after the intervention
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Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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Adherence to protocol - self-reported
Time Frame: 2 weeks
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The Social Media Use Questionnaire items assessing adherence to daily social media activities will be used to measure self-reported adherence after the intervention
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2 weeks
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Adherence to protocol - observed
Time Frame: Daily for the 14 days of the intervention
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With participant consent, a research assistant will follow the social media account the participant plans to use for the SOMEBODY intervention and will complete a checklist on a daily basis (yes/no) on whether or not the participant completed the daily assignment
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Daily for the 14 days of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pamela K Keel, Ph.D., Florida State University
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 (Actual)
March 29, 2021
Primary Completion (Actual)
April 22, 2022
Study Completion (Actual)
April 22, 2022
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 18, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001960
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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