Clinical trial NCT06963086: Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia
Official title: Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Body Image
Body Dissatisfaction
Dietary Restraint
Negative Affect
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth II Health Sciences Centre Foundation
First posted: 2025-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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 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: Inclusion Criteria:

* 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).
* Able to complete English computer-based self-report questionnaires (with adequate accommodation, if necessary).
* Provides informed consent (or verbal assent with informed consent provided by parent/guardian).

Exclusion Criteria:

* Previous participation in the Body Project.

Primary outcomes:
measure: Acceptability of the Body Project as measured with focus groups
timeFrame: Immediately following completion of the final Body Project session for each group (either week 2 or week 4, depending on age group)
Secondary outcomes:
measure: Acceptability of the Body Project as measured with program dropout rate
timeFrame: From a participant's first session (week 1) to last session (either week 2 or week 4, depending on age group).
measure: Acceptability of the Body Project as measured with the Client Satisfaction Questionnaire (CSQ)
timeFrame: After a participant's last session (either week 2 or week 4, depending on age group).
measure: Demand for the Body Project as measured with recruitment rate
timeFrame: At 24 months after recruitment begins.
measure: Effectiveness of the Body Project for reducing pursuit of the thin ideal as measured with the Thin-Ideal Internalization Scale (TIIS)
timeFrame: From baseline to after a participant's last session (either week 2 or week 4, depending on age group).
measure: Effectiveness of the Body Project for reducing body dissatisfaction as measured with the Satisfaction and Dissatisfaction with Body Parts Scale (SDBPS)
timeFrame: From baseline to after a participant's last session (either week 2 or week 4, depending on age group).
measure: Effectiveness of the Body Project for reducing negative affect as measured with the Positive Affect and Negative Affect Scale-Revised (PANAS-X)
timeFrame: From baseline to after a participant's last session (either week 2 or week 4, depending on age group).
measure: Effectiveness of the Body Project for reducing disordered eating behaviors and attitudes as measured with the Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: From baseline to after a participant's last session (either week 2 or week 4, depending on age group).
Other outcomes:
measure: Integration of the Body Project as assessed with group facilitator surveys
timeFrame: After a facilitator has completed their last session (at study completion - about 24 months after recruitment starts).
Locations:
city: Halifax
country: Canada
facility: Abbie J Lane Memorial Building, QEII Health Sciences Centre, Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Susan Gamberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
citation: Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.