NCT04810403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

March 16, 2021

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptability of intervention

    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

    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

    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 Outcomes (7)

  • Change in body image concerns

    Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

  • Change in dietary restraint

    Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

  • Change in bulimic symptoms

    Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

  • Change in disordered eating

    Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

  • Change in social media use

    Pre-intervention assessment to post-intervention assessment (or approximately 14 days from baseline)

  • +2 more secondary outcomes

Study Arms (1)

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).

Behavioral: SOMEBODY Eating Disorder Prevention Program

Interventions

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.

SOMEBODY Eating Disorder Prevention Program

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • to 25 years old
  • score in the top 50th percentile for time spent on social media each day

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University Psychology Department

Tallahassee, Florida, 32304, United States

Location

Study Officials

  • Pamela K Keel, Ph.D.

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 23, 2021

Study Start

March 29, 2021

Primary Completion

April 22, 2022

Study Completion

April 22, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations