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Clinical trial Recruiting at 3 sites Interventional Ages 14 to 17

Dialectical Behavior Therapy to help teens with obesity manage emotions and weight

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

Run by University of Manitoba · NCT05338944 · Data updated 2026-11-12

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

Study typeInterventional
Ages14 Years to 17 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity of Manitoba
Academic / other
Locations3 sites (Calgary, Alberta and 2 other locations)
StatusRecruiting
StartedJanuary 14, 2023
Main results expectedDecember 1, 2026
Study endsJanuary 31, 2027
Registry record updatedOctober 7, 2025
Trial IDNCT05338944 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Calgary
    Calgary, Alberta, Canada     Recruiting
  • University of Manitoba
    Winnipeg, Manitoba, Canada     Recruiting
  • McMaster University
    Hamilton, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.