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Clinical Trials in Canada / NCT05338944
Recruiting Not applicable

Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)

NCT05338944 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2023-01-14
Last updated
2025-10-07

Condition(s) studied

PreventionType2Diabetes

Investigational drug(s) / intervention(s)

Dialectical behavioral therapyLifestyle

Dialectical behavioral therapy: Working with psychologists through DBT skills training.

Lifestyle: Working with kinesiologist and registered dietician to improve lifestyle habits.

Study 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

Sex
ALL
Min age
14 Years
Max age
17 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
University of Calgary Calgary Alberta Recruiting
University of Manitoba Winnipeg Manitoba Recruiting
McMaster University Hamilton Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05338944 on ClinicalTrials.gov ↗ ← All trials in Canada