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SOMEBODY, a Social Media-based Eating Disorder Prevention Program

Primary Purpose

Eating Disorder Symptom

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SOMEBODY Eating Disorder Prevention Program
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorder Symptom

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Florida State University Psychology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOMEBODY Eating Disorder Prevention Program

Arm Description

All participants will be recruited to participate in the SOcial MEdia (SOME) adaptation of activities from the BODY Project (SOMEBODY).

Outcomes

Primary Outcome Measures

Acceptability of intervention
Acceptability will be evaluated with 7-point Likert scale ratings, with a score ≥5 indicating that participants found the intervention acceptable
Feasibility of intervention
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
Change in internalization of the thin ideal
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

Change in body image concerns
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
Change in dietary restraint
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
Change in bulimic symptoms
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
Change in disordered eating
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
Change in social media use
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
Adherence to protocol - self-reported
The Social Media Use Questionnaire items assessing adherence to daily social media activities will be used to measure self-reported adherence after the intervention
Adherence to protocol - observed
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

Full Information

First Posted
March 16, 2021
Last Updated
May 3, 2022
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT04810403
Brief Title
SOMEBODY, a Social Media-based Eating Disorder Prevention Program
Official Title
An Open Trial Pilot Study of SOMEBODY, a Social Media-based Eating Disorder Prevention Program for College Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Symptom

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOMEBODY Eating Disorder Prevention Program
Arm Type
Experimental
Arm Description
All participants will be recruited to participate in the SOcial MEdia (SOME) adaptation of activities from the BODY Project (SOMEBODY).
Intervention Type
Behavioral
Intervention Name(s)
SOMEBODY Eating Disorder Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of intervention
Description
Acceptability will be evaluated with 7-point Likert scale ratings, with a score ≥5 indicating that participants found the intervention acceptable
Time Frame
2 weeks
Title
Feasibility of intervention
Description
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
Time Frame
2 weeks
Title
Change in internalization of the thin ideal
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Secondary Outcome Measure Information:
Title
Change in body image concerns
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Title
Change in dietary restraint
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Title
Change in bulimic symptoms
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Title
Change in disordered eating
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Title
Change in social media use
Description
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
Time Frame
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Title
Adherence to protocol - self-reported
Description
The Social Media Use Questionnaire items assessing adherence to daily social media activities will be used to measure self-reported adherence after the intervention
Time Frame
2 weeks
Title
Adherence to protocol - observed
Description
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
Time Frame
Daily for the 14 days of the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela K Keel, Ph.D.
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University Psychology Department
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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SOMEBODY, a Social Media-based Eating Disorder Prevention Program

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