An App to Reduce Social Media's Impact on Body Image and Eating Disorders (BodyScreen)

April 2, 2025 updated by: Sandra Meier, Dalhousie University

An App to Disrupt the Link Between Social Media and Negative Body Image And Disordered Eating: A Pilot Study Of Feasibility, Acceptability, and Preliminary Efficacy

Social media (SM) is a key communication tool, particularly for young women aged 15-29. While SM fosters social connections, it is also linked to negative effects on mental health, including poor body image, low self-esteem, and maladaptive perfectionism. These issues arise due to social comparison with idealized images, especially on platforms like Instagram, which can contribute to disordered eating behaviours. Research suggests that reducing SM use can improve mental well-being, body image, and eating disorder symptoms. However, current interventions have not simultaneously addressed both reducing SM exposure and strengthening protective psychological factors. To address this gap, the proposed study aims to pilot BodyScreen, an intervention app designed to limit SM exposure while enhancing self-esteem and reducing perfectionism in young women at high risk for eating disorders. The study hypothesizes that BodyScreen will be feasible, acceptable, and effective in improving body image, self-esteem, and SM use, with sustained benefits at a 3-month follow-up. The intervention includes a virtual face-to-face session, mid-intervention email support, and a four-week app-based program using Ecological Momentary Interventions (EMIs). Participants will receive reminders to complete exercises designed to improve self-perception and reduce the negative effects of SM. Additionally, Ecological Momentary Assessment (EMA) will track real-time self-esteem, perfectionism, and body image, while mobile sensing will monitor SM use to tailor interactive exercises accordingly. By integrating exposure reduction with psychological strengthening, BodyScreen aims to provide a novel, evidence-based approach to mitigating the harmful effects of SM on young women's mental health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

The investigators will recruit a total of 50 women, aged 15-29 years, at high risk for eating disorders to take part in a 4-week daily EMI. Participants will be recruited via advertisements placed online via social media (e.g. Instagram, Facebook, Kijiji); in print, at local universities, schools, hospitals, museums, and healthcare settings; and through participant databanks in Halifax and Toronto. This two-center design will facilitate recruitment, data collection, and generalizability, as well as preparation for a future multiple-site randomized clinical trial (RCT). These methods have previously resulted in recruiting 10-15 women per month to RCTs run by Dr. Meier's laboratory alone. Consistent with the investigator's previous research, recruitment will be tailored to promote inclusivity of sexually and racially diverse women. Yet given the differences in liability to negative body image, disordered eating and SM use, the current pilot study will focus on women only. Potential participants will be invited to complete screening questions and those who are eligible at screening will be invited to proceed to the consent process. Answers will be immediately assessed by the study website using pre-defined acceptance criteria. Participants will then receive an immediate, on-screen message stating their eligibility status to continue as a participant in the study. Ineligible participants will be informed that they do not meet the study's requirements, thanked for their interest in participating, and encouraged to take part in future PROSIT studies. Those who are eligible will be invited to continue to complete consent forms. Screening and consent will be carried out using REDCap. Participants will be emailed a link to the appropriate consent form through the "REDCap" system. During online Consent, the participant will be taken through a series of sections on the website that describes what it means to participate (e.g., reiterating the right to withdraw from the study at any time) and at the end of the consent form, participants will be asked questions (i.e. true/false and yes/no) regarding the form's contents to ensure they have correctly understood the information before proceeding that they understand the study, its risks and benefits, and/or have any questions. Participants will be encouraged to contact the research staff if they have any questions regarding the study, and all questions will be answered to their satisfaction. The script is designed to give potential study participants ample time to make an informed decision about participation. The "REDCap" recruitment site will record the date and time that online Consent, along with a space for their signature. If online Consent is submitted by participants meeting the study criteria, the "REDCap" recruitment system will automatically send an email Consent Confirmation to the participants for their records. This original document will be placed in the participant's file. Once participants have submitted confirmation of consent, the Research Assistant will generate a participant ID. After the participant ID is created, the Research Assistant will email the participants with a secure link and login with instructions on how to complete the study's online questionnaires and how to download the app. Online Consent will take <15 mins. Outcome measures will be administered using the secure online survey platform (REDCap). All scales that have been selected have robust psychometric properties, good reliability and validity. At baseline, participants will report their age, sexual orientation, socioeconomic status, educational attainment, and race/ethnicity, only at baseline using the demographic questionnaire. The proposed study's primary outcomes will be body image and eating disorder symptomology, which will be assessed with the Eating Disorder Risk Composite (EDRC) score (Eating Disorder Inventory-3; EDI-3). Secondary and tertiary outcomes for this study will be self-esteem and perfectionism, which will be assessed using the 10-item Rosenberg Self-Esteem Scale (RSES) and the 45-item Big Three Perfectionism Scale (BTPS), respectively. These assessments - EDI-3, RSES, BTPS - will be administered to participants pre- and post-intervention, as well as at the 3-month follow-up. The BodyScreen app will be used to record completed EMI exercises and allow participants to report technical issues, and SM via mobile sensing. Post-intervention, all participants will be asked to self-report the usability of the app using the System Usability Scale (SUS) adapted for digital health apps on a 5-point Likert scale. Additionally, ten participants will be invited for a semi-structured interview, conducted online or in person, depending on preference, to provide more detailed feedback and suggestions on app layout, design, and usability. While participants are using the app, the app will passively record their screen time using the phone's built-in screen and app logs. For app usage, the investigators will record the name of the app, duration, and time of usage will be recorded. During the 4 weeks of the intervention, participants will also complete EMAs three times every other day to assess momentary self-esteem, perfectionism, and body image. All data will be stored on the investigator's secure servers at Dalhousie University and the IWK Health Center using SSL connections to prevent third parties' interception. Uploads will occur daily when the device is plugged in and connected to Wi-Fi.

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 (Estimated)

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 15-29 years old
  • Ability to provide informed consent
  • Access to a smartphone (iOS or Android)
  • A score greater than 47 on the Eating Disorder Risk Composite (EDRC) from the Eating Disorder Inventory-3 (EDI-3) is considered to be at high risk for an eating disorder and therefore makes a participant eligible for this study.
  • Use of social media (SM) for appearance-related reasons.

Exclusion Criteria:

  • A concurrent treatment for self-esteem, perfectionism, body image, or disordered eating, as it may interfere with the intervention under investigation and will make it difficult to attribute any symptom changes to either treatment.

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: Treatment
  • 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: BodyScreen App Arm
All participants will receive the BodyScreen app intervention. Participants will complete daily self-esteem exercises such as reflection, affirmations, challenging negative self-talk, perfectionism and low body-image.
Behavioral: BodyScreen App
The BodyScreen App uses behavioural interventions along with haptic interruptions in social media app usage. The app will engage participants by sending them notifications, reminders, and activities to complete throughout the day and the week.

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
Number of participants who show a reduced score on the Eating Disorder Risk Composite subscales from the Eating Disorder Inventory-3.
Time Frame: From enrollment to three months after completion of the study.
The proposed study's primary outcomes will be body image and eating disorder symptomology, which will be assessed with the Eating Disorder Risk Composite (EDRC) subscales from the Eating Disorder Inventory-3 (EDI-3), drive for thinness scale, bulimia scale, and body dissatisfaction scale. Each of the three subscales has a raw score range of 0 to 24. The minimum EDRC score a participant can obtain is 0, which would indicate no eating disorder risk. The maximum EDRC score a participant can obtain is 72, where they score 24 on all three EDRC subscales. Those who score higher on the EDRC are at higher risk for eating disorders; higher scores are worse outcomes, and lower scores are better outcomes.
From enrollment to three months after completion of the study.

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
Number of participants who show an increased score on the Rosenberg Self-Esteem Scale
Time Frame: From enrollment to three months after sudy completion.
The 10-item Rosenberg Self-Esteem Scale (RSES) is our secondary outcome measure, assessing overall self-esteem. Each item is rated on a 4-point Likert scale (ranging from 0 to 3), resulting in total scores from 0 to 30. Higher scores indicate better outcomes, as they reflect greater self-esteem, confidence, and self-worth. Conversely, lower scores suggest worse outcomes, indicating lower self-esteem and potential self-doubt or negative self-perception.
From enrollment to three months after sudy completion.
Number of participants who show a lowered score on the Big Three Perfectionism Scale
Time Frame: From enrollment to three months after sudy completion.
The 5-Item Big Three Perfectionism Scale (BTPS) is our tertiary outcome measure, perfectionism. Each item is rated on a 1 to 5 or 1 to 7 Likert scale, resulting in total scores ranging from 5 to 35. Higher scores indicate greater perfectionism and worse outcomes.
From enrollment to three months after sudy completion.

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.
Dalhousie University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IWK Health Centre

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 (Estimated)

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.
July 1, 2025

Primary Completion (Estimated)

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.
July 1, 2027

Study Completion (Estimated)

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.
July 1, 2027

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 20, 2025

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.
April 2, 2025

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.
April 4, 2025

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.
April 4, 2025

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.
April 2, 2025

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.
April 1, 2025

More Information

Terms related to this study

Keywords

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.
  • BODYSCREEN

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

product manufactured in and exported from the U.S.

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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