NCT06963086

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:

  • 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

April 21, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

April 21, 2025

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

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.

    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 (7)

  • Acceptability of the Body Project as measured with program dropout rate

    From a participant's first session (week 1) to last session (either week 2 or week 6, depending on group).

  • Acceptability of the Body Project as measured with a questionnaire on participant satisfaction with the program

    After a participant's last session (either week 2 or week 6, depending on group).

  • Demand for the Body Project as measured with recruitment rate

    At 24 months after recruitment begins.

  • Effectiveness of the Body Project for reducing pursuit of the thin ideal as measured with the Thin-Ideal Internalization Scale (TIIS)

    From baseline to after a participant's last session (either week 2 or week 6, depending on group).

  • Effectiveness of the Body Project for reducing body dissatisfaction as measured with the Satisfaction and Dissatisfaction with Body Parts Scale (SDBPS)

    From baseline to after a participant's last session (either week 2 or week 6, depending on group).

  • +2 more secondary outcomes

Other Outcomes (1)

  • Integration of the Body Project as assessed with group facilitator surveys

    After a facilitator has completed their last session (at study completion - about 24 months after recruitment starts).

Study Arms (1)

the Body Project

EXPERIMENTAL
Behavioral: Eating disorder prevention program (the Body Project)

Interventions

The 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.

the Body Project

Eligibility Criteria

Age15 Years - 22 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsEligible individuals are those who self-identify as a girl or woman.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Self-identify as a girl/woman.
  • Be between the ages of 15-22 years old.
  • 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).

You may not qualify if:

  • Previous participation in the Body Project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbie J Lane Memorial Building, QEII Health Sciences Centre, Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28126032BACKGROUND
  • 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.

    PMID: 10259963BACKGROUND

Study Officials

  • Susan Gamberg, PhD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Gamberg, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 8, 2025

Study Start

January 14, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations