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SOMEBODY, a Social Media-based Eating Disorder Prevention Program

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ClinicalTrials.gov Identifier: NCT04810403
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pamela Keel, Florida State University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Eating Disorder Symptom Behavioral: SOMEBODY Eating Disorder Prevention Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Trial Pilot Study of SOMEBODY, a Social Media-based Eating Disorder Prevention Program for College Women
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : May 15, 2022
Arms and Interventions
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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).
 Behavioral: SOMEBODY Eating Disorder Prevention Program
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Feasibility of intervention [ Time Frame: 2 weeks ]
    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

  3. Change in internalization of the thin ideal [ Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline) ]
    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


Secondary Outcome Measures :
  1. 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

  2. Change in dietary restraint [ Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline) ]
    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

  3. Change in bulimic symptoms [ Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline) ]
    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

  4. Change in disordered eating [ Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline) ]
    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

  5. Change in social media use [ Time Frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline) ]
    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

  6. Adherence to protocol - self-reported [ Time Frame: 2 weeks ]
    The Social Media Use Questionnaire items assessing adherence to daily social media activities will be used to measure self-reported adherence after the intervention

  7. Adherence to protocol - observed [ Time Frame: Daily for the 14 days of the intervention ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810403


Contacts
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Contact: Madeline R Wick, M.S. 2063028721 wick@psy.fsu.edu
Contact: Pamela K Keel, Ph.D. 8506459140 keel@psy.fsu.edu

Locations
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United States, Florida
Florida State University Psychology Department Recruiting
Tallahassee, Florida, United States, 32304
Contact: Pamela K Keel, Ph.D.    850-645-9140    keel@psy.fsu.edu   
Sponsors and Collaborators
Florida State University
Investigators
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Principal Investigator: Pamela K Keel, Ph.D. Florida State University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Pamela Keel, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT04810403    
Other Study ID Numbers: 00001960
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders