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

Recruiting now · Not applicable

Conditions studied: Prevention, Type2Diabetes

In brief

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.

Key facts

Study ID

NCT05338944

Run by

University of Manitoba

People needed

90

Starts

2023-01-14

Expected to finish

2027-01-31

Last updated by the study team

2025-10-07

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• University of Calgary — Calgary, Alberta, Canada (enrolling)
• University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)
• McMaster University — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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