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| Name | Class |
|---|---|
| Diabetes Canada | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT + lifestyle | Experimental | Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks. |
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| Lifestyle alone | Experimental | Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks. |
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| Control | No Intervention | Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialectical behavioral therapy | Behavioral | Working with psychologists through DBT skills training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rates | defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study | 16 weeks |
| Adherence to the intervention | defined as the percentage of prescribed sessions that adolescents/families attend during the trial | 16 weeks |
| Retention for follow up measurements | defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks | Measured at week 16 and week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Measured at baseline, 16 weeks and 32 weeks |
| Body composition measured by dual-x-ray absorptiometry (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon McGavock, PhD | Contact | 204-789-3591 | jmcgavock@chrim.ca | |
| Jana Slaght, MSc | Contact | 204-789-3591 | jslaght@chrim.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41688123 | Derived | Cameron EE, Morrison KM, Ho J, Roos L, Katz L, Mushquash A, Dart A, Wicklow BA, Senechal M, Jung ME, Strachan SM, Afifi TO, Archibald M, Andrade B, Hadjiyannakis S, Hamilton J, Slaght J, Penner K, Balshaw RF, McGavock J. 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. BMJ Open. 2026 Feb 12;16(2):e106645. doi: 10.1136/bmjopen-2025-106645. |
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90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
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| Lifestyle | Behavioral | Working with kinesiologist and registered dietician to improve lifestyle habits. |
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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 | Calculated using measured height and weight | Measured at baseline, 16 weeks and 32 weeks |
| Emotional regulation | Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire. | 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). | Measured at baseline, 16 weeks and 32 weeks |
| Depressive symptoms | Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms. | 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. | 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. | 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. | 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. | 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. | Measured at baseline, 16 weeks and 32 weeks |
| Sleep habits | 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 | 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 |
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3E3P4 | Canada |
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| McMaster University | Recruiting | Hamilton | Ontario | L8S 4L8 | Canada |
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