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NCT Number: NCT05338944

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

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.

Recruiting

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Key information

Conditions

Prevention Type2diabetes

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical behavioral therapy

Behavioral

Working with psychologists through DBT skills training.

Lifestyle

Behavioral

Working with kinesiologist and registered dietician to improve lifestyle habits.

Primary outcomes

  1. 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

  2. Adherence to the intervention

    Time frame: 16 weeks

    defined as the percentage of prescribed sessions that adolescents/families attend during the trial

  3. 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

Secondary outcomes

  1. 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

  2. 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.

  3. Body Mass Index (BMI) z-score

    Time frame: Measured at baseline, 16 weeks and 32 weeks

    Calculated using measured height and weight

  4. Emotional regulation

    Time frame: Measured at baseline, 16 weeks and 32 weeks

    Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire.

  5. 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).

  6. Depressive symptoms

    Time frame: Measured at baseline, 16 weeks and 32 weeks

    Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Slaght, MSc

CONTACT

[email protected]

204-789-3591

Jon McGavock, PhD

CONTACT

[email protected]

204-789-3591

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Diabetes Canada

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 21, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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