Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Manitoba
- Enrollment
- 90
- Locations
- 6
- Primary Endpoint
- Adherence to the intervention
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Adherence to the intervention
Time Frame: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
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
Adherence to the intervention
Time Frame: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
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
- Quality of Life measure using the PedsQL questionnaire(Measured at baseline, 16 weeks and 32 weeks)
- Body composition measured by dual-x-ray absorptiometry (DXA)(Measured at baseline, 16 weeks and 32 weeks)
- Readiness for Lifestyle Behavior Change(Measured at baseline, 16 weeks and 32 weeks)
- Quality of Life measure using the PedsQL questionnaire(Measured at baseline, 16 weeks and 32 weeks)
- Body Mass Index (BMI) z-score(Measured at baseline, 16 weeks and 32 weeks)
- Body composition measured by dual-x-ray absorptiometry (DXA)(Measured at baseline, 16 weeks and 32 weeks)
- Emotional regulation(Measured at baseline, 16 weeks and 32 weeks)
- Emotional reactive eating(Measured at baseline, 16 weeks and 32 weeks)
- Depressive symptoms(Measured at baseline, 16 weeks and 32 weeks)
- Psychological distress(Measured at baseline, 16 weeks and 32 weeks)
- Anxiety symptoms(Measured at baseline, 16 weeks and 32 weeks)
- Readiness for Lifestyle Behavior Change(Measured at baseline, 16 weeks and 32 weeks)
- Sleep habits(Measured at baseline, 16 weeks and 32 weeks)
- Objective physical activity and sleep patterns(Measured at baseline, 16 weeks and 32 weeks)
- Behavior regulation in exercise(Measured at baseline, 16 weeks and 32 weeks)
- Self-reported healthy lifestyle behaviors - physical activity and screen time(Measured at baseline, 16 weeks and 32 weeks)
Investigators
Jon McGavock
Principal Investigator
University of Manitoba