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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32304
        • Florida State University Psychology Department

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
2 weeks
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
2 weeks
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
2 weeks
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
Daily for the 14 days of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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