DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338944
• Other study ID #: HS24295
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: January 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Prevention

Intervention

Behavioral:
• Dialectical behavioral therapy
Working with psychologists through DBT skills training.
• Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Children's Hospital Research Institute of Manitoba (CHRIM), Diabetes Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence to the intervention	defined as the percentage of prescribed sessions that adolescents/families attend during the trial	16 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Feedback	What other outcomes should we consider measuring? Collected from focus groups and feedback forms.	2 weeks at 16 weeks