Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05338944

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 17 Years
SexAll
Healthy volunteersAccepted
ConditionPrevention, Type2Diabetes

Full registry criteria

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

Treatments and study arms

Dialectical behavioral therapy

Behavioral

Working with psychologists through DBT skills training.

Lifestyle

Behavioral

Working with kinesiologist and registered dietician to improve lifestyle habits.

Primary outcomes

Enrollment rates16 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 intervention16 weeks

defined as the percentage of prescribed sessions that adolescents/families attend during the trial

Retention for follow up measurementsMeasured at week 16 and week 32

defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks

Study locations

3 locations were listed when this page was built. The first 40 are shown.

University of Calgary🇨🇦 Calgary, Alberta, Canada
Josephine Ho, MDContact
Heidi Virtanen, MScContact
Josephine Ho, MDPrincipal Investigator
McMaster University🇨🇦 Hamilton, Ontario, Canada
Katherine Morrison, MD, FRCPContact
Autumn Lawrence, MScContact
Katherine Morrison, MD, FRCPPrincipal Investigator
University of Manitoba🇨🇦 Winnipeg, Manitoba, Canada
Jonathan McGavock, PhDContact
Jana Apperley, MScContact
Jonathan McGavock, PhDPrincipal Investigator