DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

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

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 Overview

• Status: Active, not recruiting
• Conditions: Prevention; Type2Diabetes
• Intervention / Treatment: Behavioral: Dialectical behavioral therapy; Behavioral: Lifestyle

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E3P4
      • University of Manitoba
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Diabetes Canada; Children's Hospital Research Institute of Manitoba (CHRIM)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 31, 2026

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: HS24295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No