Eating Disorder SymptomNCT04810403
SOMEBODY, a Social Media-based Eating Disorder Prevention Program
A study testing SOMEBODY Eating Disorder Prevention Program in people with Eating Disorder Symptom, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Symptom
- What is being tested?
- SOMEBODY Eating Disorder Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 22 Apr 2022
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- 18 to 25 years old
- score in the top 50th percentile for time spent on social media each day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University Psychology Department
Tallahassee, Florida, 32304
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorder Symptom
- Being tested
- SOMEBODY Eating Disorder Prevention Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMEBODY Eating Disorder Prevention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SOMEBODY Eating Disorder Prevention Program | Experimental | All participants will be recruited to participate in the SOcial MEdia (SOME) adaptation of activities from the BODY Project (SOMEBODY). Receives: Behavioral: SOMEBODY Eating Disorder Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention
Acceptability will be evaluated with 7-point Likert scale ratings, with a score ≥5 indicating that participants found the intervention acceptable
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Secondary outcomes (7)
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Measured: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
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
Measured: 2 weeks
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
Measured: Daily for the 14 days of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start29 Mar 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder SymptomStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Keel, Florida State University
- Investigators
- Pamela K Keel, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810403
- Sponsor's protocol ID
- 00001960
- Status last verified
- May 2022
- First submitted
- 16 Mar 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial Pilot Study of SOMEBODY, a Social Media-based Eating Disorder Prevention Program for College Women
- ClinicalTrials.gov ID
- NCT04810403
- Acronym / sponsor ID
- 00001960
- Conditions
- Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 23 Mar 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOMEBODY Eating Disorder Prevention Program | Experimental | Behavioral: SOMEBODY Eating Disorder Prevention ProgramAll participants will be recruited to participate in the SOcial MEdia (SOME) adaptation of activities from the BODY Project (SOMEBODY). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female
- 18 to 25 years old
- score in the top 50th percentile for time spent on social media each day
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| SOMEBODY Eating Disorder Prevention ProgramParticipants 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. | Behavioural | SOMEBODY Eating Disorder Prevention Program |
Primary outcome
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
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
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
7 secondary outcomes
Change in body image concerns
Time frame: 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)
Change in bulimic symptoms
Time frame: 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)
Change in social media use
Time frame: Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)
Adherence to protocol - self-reported
Time frame: 2 weeks
Adherence to protocol - observed
Time frame: Daily for the 14 days of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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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.
Pamela K Keel, Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOMEBODY Eating Disorder Prevention Program in people with Eating Disorder Symptom, run by Florida State University at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability of intervention (time frame: 2 weeks). 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 4 May 2022.