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

October 2, 2025 updated by: Jon McGavock, University of Manitoba
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • University of Calgary
        • Contact:
        • Principal Investigator:
          • Josephine Ho, MD
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3P4
        • Recruiting
        • University of Manitoba
        • Principal Investigator:
          • Emily Cameron, PhD
        • Principal Investigator:
          • Jonathan McGavock, PhD
        • Contact:
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • Recruiting
        • McMaster University
        • Contact:
        • Principal Investigator:
          • Katherine Morrison, MD, FRCP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.
Experimental: DBT + lifestyle
Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.
Behavioral: Dialectical behavioral therapy
Working with psychologists through DBT skills training.
Behavioral: Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.
Experimental: Lifestyle alone
Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.
Behavioral: Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the intervention
Time Frame: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
16 weeks
Enrollment rates
Time Frame: 16 weeks
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
16 weeks
Retention for follow up measurements
Time Frame: Measured at week 16 and week 32
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
Measured at week 16 and week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life measure using the PedsQL questionnaire
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measure using the PedsQL questionnaire, subscales of emotional, social and health-related QOL will be treated separately and as a composite measure
Measured at baseline, 16 weeks and 32 weeks
Body composition measured by dual-x-ray absorptiometry (DXA)
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measurements of % body fat, total fat, trunk fat, muscle mass, estimated VAT mass, estimated VAT volume and estimated VAT area will be collected, along with height and weight.
Measured at baseline, 16 weeks and 32 weeks
Body Mass Index (BMI) z-score
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Calculated using measured height and weight
Measured at baseline, 16 weeks and 32 weeks
Emotional regulation
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire.
Measured at baseline, 16 weeks and 32 weeks
Emotional reactive eating
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measurement using the Child version of the Three-Factor Eating Questionnaire (TFEQ-R20 C).
Measured at baseline, 16 weeks and 32 weeks
Depressive symptoms
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms.
Measured at baseline, 16 weeks and 32 weeks
Psychological distress
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measured using the Kessler Emotional Distress Scale (K6) to assess psychological distress using six items covering depression and anxiety in the most recent 30 days.
Measured at baseline, 16 weeks and 32 weeks
Anxiety symptoms
Time Frame: Measured at baseline, 16 weeks and 32 weeks
The parent and child version of the Screen for Child Anxiety Related Disorders (SCARED) questionnaire will be used to measure anxiety symptoms.
Measured at baseline, 16 weeks and 32 weeks
Readiness for Lifestyle Behavior Change
Time Frame: Measured at baseline, 16 weeks and 32 weeks
Measured using the PACE readiness questionnaire which assesses readiness for changing dietary habits, daily activity goals and screen time.
Measured at baseline, 16 weeks and 32 weeks
Behavior regulation in exercise
Time Frame: Measured at baseline, 16 weeks and 32 weeks
The BREQ3 (Behavioral Regulation in ExerciseQuestionnaire-3), will be used to measure of the level of motivation to engage in exercise from a self determination perspective.
Measured at baseline, 16 weeks and 32 weeks
Self-reported healthy lifestyle behaviors - physical activity and screen time
Time Frame: Measured at baseline, 16 weeks and 32 weeks

Measured using the CANPWR questionnaire on physical activity and screen time habits.

McPhee PG, Zenlea I, Hamilton JK, Ho J, Ball GDC, Mian R, Buchholz A, Laberge AM, Legault L, Tremblay MS, Chanoine JP, Thabane L, Morrison KM. Individual and family characteristics associated with health indicators at entry into multidisciplinary pediatric weight management: findings from the CANadian Pediatric Weight management Registry (CANPWR). Int J Obes (Lond). 2022 Jan;46(1):85-94. doi: 10.1038/s41366-021-00959-3. Epub 2021 Sep 9. PMID: 34504287.
Measured at baseline, 16 weeks and 32 weeks
Sleep habits
Time Frame: Measured at baseline, 16 weeks and 32 weeks
The Sleep Disturbance Assessment Form (PROMIS) will be used to capture sleep habits.
Measured at baseline, 16 weeks and 32 weeks
Objective physical activity and sleep patterns
Time Frame: Measured at baseline, 16 weeks and 32 weeks
A wrist worn fitbit will collect physical activity data and sleep data for 7 days at each timepoint. Data collected includes: steps per day, minutes of activity in low, moderate and high intensity, and total minutes of sleep per night.
Measured at baseline, 16 weeks and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Canadian Institutes of Health Research (CIHR)
Diabetes Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS24295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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