Actively Recruiting

Phase Not Applicable
Age: 14Years - 17Years
All Genders
Healthy Volunteers
NCT05338944

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

Led by University of Manitoba · Updated on 2025-10-07

90

Participants Needed

3

Research Sites

211 weeks

Total Duration

On this page

Sponsors

U

University of Manitoba

Lead Sponsor

D

Diabetes Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 14 to 17 years old
  • BMI z-score greater than 1.4
  • Signs of mild to moderate depression (PHQ-9 score 5-19)
  • Willing and able to follow study procedures
Not Eligible

You will not qualify if you...

  • More than one health co-morbidity
  • Currently treated with medication for obesity
  • Taking steroids
  • Being treated with atypical antipsychotics
  • Orthopedic injury or chronic illness preventing participation
  • Experienced weight loss or enrolled in weight loss program in past 6 months
  • Prescribed any weight loss medication including Ozempic in past 12 months
  • History of alcoholism or drug abuse
  • History of self-harm or suicide attempts in past 12 months
  • Currently enrolled in psychotherapy or DBT
  • Parents do not approve participation
  • Unable to read, speak, or understand English
  • Unable or unwilling to give assent or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

2

University of Manitoba

Winnipeg, Manitoba, Canada, R3E3P4

Actively Recruiting

3

McMaster University

Hamilton, Ontario, Canada, L8S 4L8

Actively Recruiting

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Research Team

J

Jon McGavock, PhD

CONTACT

J

Jana Slaght, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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