Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-22
SponsorSusan Gamberg
About this trial
The goal of this study is to evaluate the Body Project, which is an eating disorder prevention program for youth 15-22 years old. The main question it aims to answer is 'Can an eating disorder prevention program, specifically the Body Project, be successfully delivered to youth in Nova Scotia'?
This study will determine the feasibility of implementing the Body Project in Nova Scotia by assessing the following objectives:
1. Acceptability (how well the Body Project is received by, and the extent to which it is perceived as meeting the needs of, youth in Nova Scotia). 2. Demand (the extent to which youth in Nova Scotia are interested in and willing to engage with the program). 3. Integration (the extent to which the Body Project is judged as feasible by the group facilitators). 4. Effectiveness (the extent to which the Body Project reduces eating disorder risk factors in youth in Nova Scotia).
Participants will:
* Attend a total of 4-4.5 hours of Body Project group sessions, which are led by peer mentors. * Complete outcome measure questionnaires before their first session and after their last session. * Participate in a focus group with their session group members after their last session.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identify as a girl/woman.
Be between the ages of 15-22 years old.
For inclusion in an in-person group, an individual must be currently enrolled as a student at the school where they will participate in sessions.
For inclusion in a virtual BP group, an individual must live in and/or attend school in Nova Scotia, and have access to a computer (e.g., laptop, desktop computer, cellphone) with internet connection and a webcam that can be used in a private location (if a participant does not have a private location to use when attending sessions, they will be asked to wear headphones).
Disqualifiers
Previous participation in the Body Project.
Trial design
Design model
Single group
Treatments tested in this trial
Eating disorder prevention program (the Body Project)
BehavioralThe Body Project is an eating disorder prevention program for girls and young women aged 15-22 years old. The program will be delivered in groups of 6-10 youth by peer mentors, and in two formats: in-person and virtual. We are assessing two versions of the program - a 6-session version (6 weekly 45-minute sessions) and a 2-session version (2 weekly 2-hour sessions). Participants will be divided into 4 cohorts: high school in-person, university in-person, high school-aged (15-18 years) virtual, and university-aged (19-22 years) virtual. The high school in-person groups will do the 6-session version, and the university in-person groups as well as all virtual groups will do 2 weekly 2-hour sessions. Both versions cover similar content, and use a scripted intervention manual.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: the Body ProjectExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of the Body Project as measured with focus groups
All participants will complete a focus group with their fellow Body Project group members immediately following their final session. The focus group will follow a semi-structured guide based on a framework for assessing acceptability of health interventions.
Time frame
Immediately following completion of the final Body Project session for each group (week 2 for university and virtual groups; or week 6 for high school in-person groups)Secondary outcomes
1
Acceptability of the Body Project as measured with program dropout rate
Participants will be coded as a 'dropout' from the intervention if they stop attending sessions (determined with session attendance records from group facilitators). Acceptability based on dropout rate will be indicated if the dropout rate in the final session is equal to, or less than, the 20-30% rate reported in effectiveness trials for the BP.
Time frame
From a participant's first session (week 1) to last session (either week 2 or week 6, depending on group).2
Acceptability of the Body Project as measured with a questionnaire on participant satisfaction with the program
Acceptability in terms of satisfaction with the program will be measured using an investigator-created questionnaire based on the Client Satisfaction Questionnaire - an 8-item self-report measure of the quality and effectiveness of a health service. Item responses are on a 4-point scale. Scores range from 8-32, with higher scores indicating higher satisfaction. Acceptability based on satisfaction questionnaire scores will be demonstrated if participants, on average, report at least moderate satisfaction (defined as a score of 24).
Time frame
After a participant's last session (either week 2 or week 6, depending on group).3
Demand for the Body Project as measured with recruitment rate
Demand feasibility will be met if there are enough participants to run 3-5 rounds of Body Project groups per cohort (totaling 96-120 youth) during the recruitment period.
Time frame
At 24 months after recruitment begins.4
Effectiveness of the Body Project for reducing pursuit of the thin ideal as measured with the Thin-Ideal Internalization Scale (TIIS)
The TIIS is the modernized version of the Ideal Body Stereotype Scale and is an 8-item self-report measure assessing internalization of the thin beauty ideal. Response options range from 1 = strongly disagree to 5 = strongly agree. Scores range from 8-40, with higher scores indicating higher internalization of the thin ideal. Feasibility will be met if there are significant within-group reductions of at least a moderate effect size (Cohen's d \> 0.5).
Time frame
From baseline to after a participant's last session (either week 2 or week 6, depending on group).Other outcomes
1
Integration of the Body Project as assessed with group facilitator surveys
Facilitators will complete an open-ended feedback survey to ascertain what went well, what alterations (if any) are needed, and what barriers facilitators encountered or identified.
Time frame
After a facilitator has completed their last session (at study completion - about 24 months after recruitment starts).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Susan Gamberg
Lead sponsor
Nova Scotia Health Authority
Sponsor institution
Queen Elizabeth II Health Sciences Centre Foundation
Collaborator
Source ClinicalTrials.gov