Body ImageEDPP-P2NCT06963086
Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia
A study testing Eating disorder prevention program (the Body Project) in people with Body Image and Body Dissatisfaction, run by Susan Gamberg at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Image, Body Dissatisfaction, Dietary Restraint
- What is being tested?
- Eating disorder prevention program (the Body Project)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Previous participation in the Body Project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Abbie J Lane Memorial Building, QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E2
Susan Gamberg, PhD, 902-473-2239, susan.gamberg@nshealth.ca
About this study
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:
Read more
- 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).
- Demand (the extent to which youth in Nova Scotia are interested in and willing to engage with the program).
- Integration (the extent to which the Body Project is judged as feasible by the group facilitators).
- 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.
- Conditions
- Body Image, Body Dissatisfaction, Dietary Restraint, Negative Affect
- Being tested
- Eating disorder prevention program (the Body Project)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating disorder prevention program (the Body Project)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the Body Project | Experimental | Not described Receives: Behavioral: Eating disorder prevention program (the Body Project) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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)
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).
Measured: 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)
Nine items from the Body Image Satisfaction Scale will be used to assess satisfaction with nine body parts, in line with previous Body Project research. Responses range from 1 = extremely satisfied to 6 = extremely dissatisfied. Scores range from 9-54, with higher scores indicating greater dissatisfaction. Feasibility will be met if there are significant within-group reductions of at least a moderate effect size (Cohen's d > 0.5).
Measured: 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 negative affect as measured with the Positive Affect and Negative Affect Scale-Revised (PANAS-X)
In line with previous BP research, 20 items from the PANAS-X subscales for sadness, guilt, and fear/anxiety will be used to assess negative affect. Responses range from 1 = not at all to 5 = extremely. Scores range from 20-100, with higher scores indicating greater negative affect. Feasibility will be met if there are significant within-group reductions of at least a moderate effect size (Cohen's d > 0.5).
Measured: 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 disordered eating behaviors and attitudes as measured with the Eating Disorder Examination Questionnaire (EDE-Q)
The EDE-Q global score is calculated from 22 attitudinal questions regarding eating restraint and concerns, weight concerns, and shape concerns. EDE-Q global scores range from 0-6, with higher scores indicating increased severity of ED psychopathology. Feasibility will be met if there are significant within-group reductions of at least a moderate effect size (Cohen's d > 0.5).
Measured: From baseline to after a participant's last session (either week 2 or week 6, depending on group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start14 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susan Gamberg
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre Foundation
- Responsible party
- Sponsor-investigator, Susan Gamberg, Nova Scotia Health Authority
- Investigators
- Susan Gamberg, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963086
- Sponsor's protocol ID
- EDPP-P2
- Acronym
- EDPP-P2
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28126032Attkisson 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.
PubMed 10259963
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Eating Disorder Prevention Program for Youth in Nova Scotia
- ClinicalTrials.gov ID
- NCT06963086
- Acronym / sponsor ID
- EDPP-P2 / EDPP-P2
- Conditions
- Body Image, Body Dissatisfaction, Dietary Restraint, Negative Affect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Susan GambergUniversity, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre Foundation
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 May 2025 (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.
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:
- 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).
- Demand (the extent to which youth in Nova Scotia are interested in and willing to engage with the program).
- Integration (the extent to which the Body Project is judged as feasible by the group facilitators).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the Body Project | Experimental | Behavioral: Eating disorder prevention program (the Body Project) |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Previous participation in the Body Project.
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 |
|---|---|---|
| Eating disorder prevention program (the Body Project)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. | Behavioural | the Body Project |
Primary outcome
Acceptability of the Body Project as measured with focus groups
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)
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.
7 secondary outcomes
Acceptability of the Body Project as measured with program dropout rate
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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 negative affect as measured with the Positive Affect and Negative Affect Scale-Revised (PANAS-X)
Time frame: 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 disordered eating behaviors and attitudes as measured with the Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: From baseline to after a participant's last session (either week 2 or week 6, depending on group).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 28126032Sekhon 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.
- Background: PubMed 10259963Attkisson 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.
- 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.
Susan Gamberg, PhD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating disorder prevention program (the Body Project) in people with Body Image and Body Dissatisfaction, run by Susan Gamberg at 1 site in Canada.
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 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Gamberg, PhD (902-473-2239, susan.gamberg@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Body Project as measured with focus groups (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)). 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 NCT06963086, which also lists 2 linked publications.
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 15 Jan 2026.