Abbie J Lane Memorial Building, QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E2, Canada
Location status: Recruiting
NCT Number: NCT06963086
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.
Interested in participating?
Request Info15 year–22 year
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3H 2E2, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From a participant's first session (week 1) to last session (either week 2 or week 6, depending on group).
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: After a participant's last session (either week 2 or week 6, depending on group).
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: At 24 months after recruitment begins.
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: From baseline to after a participant's last session (either week 2 or week 6, depending on group).
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).
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).
Time frame: From baseline to after a participant's last session (either week 2 or week 6, depending on group).
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).
Time frame: From baseline to after a participant's last session (either week 2 or week 6, depending on group).
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).
Time frame: After a facilitator has completed their last session (at study completion - about 24 months after recruitment starts).
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.
Contact information is provided by the study sponsor or research team.
Susan Gamberg
Other
Acronym: EDPP-P2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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