An interventional study of Dialectical behavioral therapy and Lifestyle in Prevention and Type2Diabetes, sponsored by University of Manitoba. Recruiting at 3 sites in Canada. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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.
University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.
Behavioral: Dialectical behavioral therapy · Behavioral: Lifestyle
Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.
Behavioral: Lifestyle
Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.
Working with psychologists through DBT skills training.
Working with kinesiologist and registered dietician to improve lifestyle habits.
Enrollment rates
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
Time frame: 16 weeks
Adherence to the intervention
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Time frame: 16 weeks
Retention for follow up measurements
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
Time frame: Measured at week 16 and week 32
Quality of Life measure using the PedsQL questionnaire
Measure using the PedsQL questionnaire, subscales of emotional, social and health-related QOL will be treated separately and as a composite measure
Time frame: Measured at baseline, 16 weeks and 32 weeks
Body composition measured by dual-x-ray absorptiometry (DXA)
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.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Body Mass Index (BMI) z-score
Calculated using measured height and weight
Time frame: Measured at baseline, 16 weeks and 32 weeks
Emotional regulation
Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Emotional reactive eating
Measurement using the Child version of the Three-Factor Eating Questionnaire (TFEQ-R20 C).
Time frame: Measured at baseline, 16 weeks and 32 weeks
Depressive symptoms
Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Psychological distress
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.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Anxiety symptoms
The parent and child version of the Screen for Child Anxiety Related Disorders (SCARED) questionnaire will be used to measure anxiety symptoms.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Readiness for Lifestyle Behavior Change
Measured using the PACE readiness questionnaire which assesses readiness for changing dietary habits, daily activity goals and screen time.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Behavior regulation in exercise
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.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Self-reported healthy lifestyle behaviors - physical activity and screen time
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.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Sleep habits
The Sleep Disturbance Assessment Form (PROMIS) will be used to capture sleep habits.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Objective physical activity and sleep patterns
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.
Time frame: Measured at baseline, 16 weeks and 32 weeks
Plan to share: Undecided
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University of Manitoba