Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)

University of Manitoba

Status: Enrolling

Conditions: Prevention; Type2Diabetes

Treatments: Behavioral: Dialectical behavioral therapy; Behavioral: Lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT05338944

HS24295

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

DBT + lifestyle

Experimental group

Description:

Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.

Treatment:

Behavioral: Lifestyle

Behavioral: Dialectical behavioral therapy

Lifestyle alone

Experimental group

Description:

Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.

Treatment:

Behavioral: Lifestyle

Control

No Intervention group

Description:

Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.