Eating DisordersNCT04433247
Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery
A study testing Peer Led Group Intervention in people with Eating Disorders, run by Stanford University at 1 site in United States.
Trial summary
This proposed pilot study will evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month… Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Peer Led Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 31 May 2021
- 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 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Body image concerns
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program
This proposed pilot study will evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month follow-up in this population.
Read the detailed description
Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. Although undergraduate peer-educator-led Body Project groups have produced larger reductions in outcomes than an eating disorder education video, an unmoderated Internet-based prevention program, and even clinician-led Body Project groups, it can be logistically difficult to schedule in-person Body Project groups with high school and college students. One solution to this key implementation barrier is to have peer educators deliver Body Project groups virtually over the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered peer-led Body Project groups produced greater reductions in eating disorder symptoms and future onset of eating disorders than an active expressive-writing intervention. The proposed pilot study will evaluate whether Body Project produces greater reductions in risk factor symptoms, eating disorder symptoms, and future onset of eating disorders in this population.
Participation in the intervention will last four weeks. Participants will be randomly assigned to the intervention condition or waitlist-control condition. Assessments will take place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control participants will receive the intervention after they complete their post-test assessment.
- Conditions
- Eating Disorders
- Being tested
- Peer Led Group Intervention
- Keywords
- Prevention, Peer Leader, Feeding and Eating Disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Led Group InterventionBehavioural
Also called Body Project
Four week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| Peer Led Group Intervention | Experimental | In the virtual peer-led group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention. Receives: Behavioral: Peer Led Group Intervention |
| Wait-List Control | No intervention | Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in Body Dissatisfaction
Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied
Measured: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Change over time in Thin Ideal Internalization
The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
Measured: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Secondary outcomes (3)
Change over time in Negative Affect
Twenty items from the sadness, guilt, and fear/anxiety subscales from the Positive Affect and Negative Affect Scale-Revised will assess negative affect. Participants reported the extent to which they had felt negative emotions on scales ranging from 1 = very slightly or not at all to 5 = extremely.
Measured: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Change over time in Dieting
The 10-item Dutch Restrained Eating Scale will assess the frequency of dieting behaviors using a response scale ranging from 1 = never to 5 = always.
Measured: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Change over time in Eating Disorder symptoms
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview
Measured: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion 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 posted16 Jun 2020
- Study start3 Mar 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Stice, Stanford University
- Investigators
- Eric Stice, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433247
- Sponsor's protocol ID
- 54596
- Status last verified
- Sep 2021
- First submitted
- 10 Jun 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stice E, Bohon C, Shaw H, Desjardins CD. Efficacy of virtual delivery of a dissonance-based eating disorder prevention program and evaluation of a donation model to support sustained implementation. J Consult Clin Psychol. 2023 Mar;91(3):139-149. doi: 10.1037/ccp0000796. Epub 2023 Feb 6.
PubMed 36745074
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program
- ClinicalTrials.gov ID
- NCT04433247
- Acronym / sponsor ID
- 54596
- Conditions
- Eating Disorders
- Keywords
- Prevention, Peer Leader, Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 16 Jun 2020 (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.
This proposed pilot study will evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month follow-up in this population.
Detailed description
Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. Although undergraduate peer-educator-led Body Project groups have produced larger reductions in outcomes than an eating disorder education video, an unmoderated Internet-based prevention program, and even clinician-led Body Project groups, it can be logistically difficult to schedule in-person Body Project groups with high school and college students. One solution to this key implementation barrier is to have peer educators deliver Body Project groups virtually over the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered peer-led Body Project groups produced greater reductions in eating disorder symptoms and future onset of eating disorders than an active expressive-writing intervention. The proposed pilot study will evaluate whether Body Project produces greater reductions in risk factor symptoms, eating disorder symptoms, and future onset of eating disorders in this population.
Participation in the intervention will last four weeks. Participants will be randomly assigned to the intervention condition or waitlist-control condition. Assessments will take place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control participants will receive the intervention after they complete their post-test assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Led Group Intervention | Experimental | Behavioral: Peer Led Group InterventionIn the virtual peer-led group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention. |
| Wait-List Control | No intervention | –Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Body image concerns
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Peer Led Group InterventionAlso: Body ProjectFour week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions. | Behavioural | Peer Led Group Intervention |
Primary outcome
Change over time in Body Dissatisfaction
Time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied
Change over time in Thin Ideal Internalization
Time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
3 secondary outcomes
Change over time in Negative Affect
Time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Change over time in Dieting
Time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Change over time in Eating Disorder symptoms
Time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion 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 28 Sep 2021.
- Derived from this study: PubMed 36745074Stice E, Bohon C, Shaw H, Desjardins CD. Efficacy of virtual delivery of a dissonance-based eating disorder prevention program and evaluation of a donation model to support sustained implementation. J Consult Clin Psychol. 2023 Mar;91(3):139-149. doi: 10.1037/ccp0000796. Epub 2023 Feb 6.
- 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.
Eric Stice, PhD principal investigator
Stanford 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 Peer Led Group Intervention in people with Eating Disorders, run by Stanford 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 1 inclusion and 1 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 28 Sep 2021. 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?
Change over time in Body Dissatisfaction (time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433247, which also lists 1 linked publication.
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 28 Sep 2021.