DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Dialectal Behavioural Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity

Conditions
-----------------
Prevention, Type2Diabetes

Intervention / Treatment
-----------------
* Behavioral: Dialectical behavioral therapy
* Behavioral: Lifestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-17 years old BMI z-score >1.6 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 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/unwilling to give assent/consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBT + lifestyle<br>Participants will receive 90 minutes of dialectical behavioral therapy and 60 minutes of lifestyle sessions each week for 16 weeks. | Behavioral: Dialectical behavioral therapy<br>* Working with psychologists through DBT skills training.<br>Behavioral: Lifestyle<br>* Working with kinesiologist and registered dietician to improve lifestyle habits.<br>|
| Experimental: Lifestyle alone<br>Participants will receive 2 lifestyle sessions per week, one 90 minutes in length and the other 60 minutes for 16 weeks. | Behavioral: Lifestyle<br>* Working with kinesiologist and registered dietician to improve lifestyle habits.<br>|
| No Intervention: Control<br>Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 6 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 | one week at week 16 and week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers for lifestyle change | What are the barriers for lifestyle change for adolescents. Collected through focus groups and photovoice participation at 16 weeks. | 2 weeks at 16 weeks | 
| Delivery of behavioral intervention | What are the preferred intervention attributes for delivering a behavioral intervention? Collected from focus groups and feedback forms. | 2 weeks at 16 weeks | 
| DBT skills training | How appropriate is DBT skills training for adolescents and their families? Collected from focus groups and feedback forms. | 2 weeks at 16 weeks | 
| DBT benefits and challenges | What are the perceived benefits and challenges associated with DBT-enhanced intensive lifestyle therapy? Collected from focus groups and feedback forms. | 2 weeks at 16 weeks | 
| Patient centered | How patient-centered are the proposed tools for assessing mental health co-morbidities and self-regulation? Collected from focus groups and feedback forms. | 2 weeks at 16 weeks | 
| Feedback | What other outcomes should we consider measuring? Collected from focus groups and feedback forms. | 2 weeks at 16 weeks |