NCT05338944Recruiting
Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Apr 2022
- Start date
- 14 Jan 2023
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- University of Manitoba
- Diseases
- Obesity
- NCT number
- NCT05338944
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 14 Jan 2023 to the primary completion date, 1 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- being treated with medication for obesity
- taking steroids
- experienced weight loss or enrolled in weight loss program in the six months prior to the study
- they are currently and/or in the past 12 months have been prescribed any weight loss medication(s) including Ozempic
Other illness
- have an orthopedic injury or chronic illness that would prevent them from performing the intervention
- self reported history of alcoholism or drug abuse
- history of self-harm or suicide attempts in the past 12 months
Other
- more than one health co-morbidity
- currently being treated for atypical antipsychotics
- currently enrolled in psychotherapy or DBT
- parents do not approve of you participating
- unable to read, speak and understand English as translation will not be provided
- unable/unwilling to give assent/consent
Who the study is looking for
- 14-17 years old
- BMI z-score \>1.4
- signs of mild-moderate depression (PHQ-9 score 5-19)
- willing and able to comply with study procedures
Age in the registry: 14 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| McMaster University Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.