DBT and Lifestyle Change to Prevent Type 2 Diabetes in Adolescents
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DBT + lifestyle Participants will receive 90 minutes of dialectical behavioral therapy and 60 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, one 90 minutes in length and the other 60 minutes for 16 weeks. |
Behavioral: Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.
|
| No Intervention: Control Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention. |
Outcome Measures
Primary Outcome Measures
- Enrollment rates [6 weeks]
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
- Adherence to the intervention [16 weeks]
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
- Retention for follow up measurements [one week at week 16 and week 32]
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
Secondary Outcome Measures
- Barriers for lifestyle change [2 weeks at 16 weeks]
What are the barriers for lifestyle change for adolescents. Collected through focus groups and photovoice participation at 16 weeks.
- Delivery of behavioral intervention [2 weeks at 16 weeks]
What are the preferred intervention attributes for delivering a behavioral intervention? Collected from focus groups and feedback forms.
- DBT skills training [2 weeks at 16 weeks]
How appropriate is DBT skills training for adolescents and their families? Collected from focus groups and feedback forms.
- DBT benefits and challenges [2 weeks at 16 weeks]
What are the perceived benefits and challenges associated with DBT-enhanced intensive lifestyle therapy? Collected from focus groups and feedback forms.
- Patient centered [2 weeks at 16 weeks]
How patient-centered are the proposed tools for assessing mental health co-morbidities and self-regulation? Collected from focus groups and feedback forms.
- Feedback [2 weeks at 16 weeks]
What other outcomes should we consider measuring? Collected from focus groups and feedback forms.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Manitoba | Winnipeg | Manitoba | Canada | R3E3P4 |
Sponsors and Collaborators
- University of Manitoba
- Diabetes Canada
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS24295