Dialectical Behavior Therapy to help teens with obesity manage emotions and weight
Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
This program will try weekly group sessions that combine Dialectical Behavior Therapy with lifestyle coaching to see if it helps 14–17-year-olds with obesity and mild-to-moderate depression improve quality of life and weight control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 14 Years to 17 Years |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 3 sites (Calgary, Alberta and 2 other locations) |
| Trial ID | NCT05338944 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls 14–17-year-olds with elevated BMI (z-score >1.4) and mild-to-moderate depressive symptoms (PHQ-9 5–19) who are at risk for type 2 diabetes. Participants are randomly assigned to weekly group-based sessions in one of three arms: lifestyle + DBT, lifestyle alone, or a control arm. The DBT-based intervention includes mindfulness, distress tolerance, emotion regulation, and relationship skills delivered alongside standard lifestyle support. Study outcomes include quality of life, weight-related measures, and diabetes risk markers collected over the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 14–17-year-olds with BMI z-score >1.4 and mild-to-moderate depression (PHQ-9 5–19) who have no major medical comorbidities, are not using weight-loss medications, and can attend weekly group sessions.
Not a fit: Patients with multiple health comorbidities, recent or ongoing formal weight-loss programs or weight-loss medications (including GLP-1 agonists), severe psychiatric illness or recent self-harm, inability to attend weekly in-person sessions, or inability to read English are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, this approach could improve emotional regulation, quality of life, and weight control in teens and lower their future risk of type 2 diabetes.
How similar studies have performed: DBT has shown benefit for emotion regulation and some disordered eating behaviors in adolescents, but evidence is limited and mixed regarding direct effects on weight loss or prevention of type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta and 2 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Jon McGavock, PhD
- Email: jmcgavock@chrim.ca
- Phone: 204-789-3591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.