NCT05338944 Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
| NCT ID | NCT05338944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manitoba |
| Condition | Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-01-14 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-01-14 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * more than one health co-morbidity * being treated with medication for obesity * taking steroids * currently being treated for atypical antipsychotics * have an orthopedic injury or chronic illness that would prevent them from performing the intervention * 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 * self reported history of alcoholism or drug abuse * history of self-harm or suicide attempts in the past 12 months * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05338944 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 17 Years, studying Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05338944 currently recruiting?
Yes, NCT05338944 is actively recruiting participants. Contact the research team at jmcgavock@chrim.ca for enrollment information.
Where is the NCT05338944 trial being conducted?
This trial is being conducted at Calgary, Canada, Winnipeg, Canada, Hamilton, Canada.
Who is sponsoring the NCT05338944 clinical trial?
NCT05338944 is sponsored by University of Manitoba. The trial plans to enroll 90 participants.