Actively Recruiting

Phase Not Applicable
Age: 14Years - 17Years
All Genders
Healthy Volunteers
ID05338944

Dialectical Behavioral 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

8 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

Researchers are evaluating a special type of therapy called Dialectical Behavioral Therapy (DBT) that includes mindfulness, distress tolerance, and relationship support. The study aims to see if this therapy can improve quality of life and help with weight management in adolescents aged 14 to 17 who are at risk for type 2 diabetes. Participants will be randomly assigned to one of three groups to compare different approaches for at-risk youth. Participants will be placed into one of three groups: one group will have weekly 90-minute DBT sessions plus 90-minute lifestyle sessions for 16 weeks; another group will have two 90-minute lifestyle sessions weekly for 16 weeks without DBT; and a control group will not receive any intervention but will undergo measurements. The lifestyle sessions focus on improving habits with the help of a kinesiologist and dietician, while DBT sessions involve skills training with psychologists. During the study, participants will attend baseline, endpoint (week 16), and follow-up (week 32) assessments. These include quality of life questionnaires, body composition scans using dual-x-ray absorptiometry, body mass index measurements, and evaluations of emotional regulation, depressive and anxiety symptoms, psychological distress, eating behaviors, physical activity, sleep habits, and readiness for lifestyle change. The study also tracks enrollment, adherence, and retention rates throughout the 16-week intervention and follow-up periods.

CONDITIONS

Brief 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...

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

You will not qualify if you...

  • More than one additional health condition
  • Currently treated with medication for obesity
  • Taking steroids
  • Receiving treatment with atypical antipsychotics
  • Have an orthopedic injury or chronic illness preventing participation
  • Lost weight or joined a weight loss program in the past 6 months
  • Used weight loss medications including Ozempic in the past 12 months
  • History of alcoholism or drug abuse
  • History of self-harm or suicide attempts in the past 12 months
  • Currently enrolled in psychotherapy or DBT
  • Parental disapproval of participation
  • Unable to read, speak, and understand English
  • Unable or unwilling to provide assent or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants receive weekly behavioral therapy and lifestyle sessions or lifestyle sessions alone for 16 weeks to support health behavior change.

Weekly visits for up to 16 weeks

Follow-up

Duration - 16 weeks

Participants have follow-up measurements to assess retention and health outcomes after the treatment period.

2 visits (in-person) at Week 16 and Week 32

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

J

Jana Slaght, MSc

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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Published Research Related To This Trial

Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot randomised controlled trial in three centres in Canada.

Emily E Cameron, Katherine M Morrison, Josephine Ho...

https://pubmed.ncbi.nlm.nih.gov/41688123