Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
NCT ID: NCT05338944
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-01-14
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DBT + lifestyle
Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.
Dialectical behavioral therapy
Working with psychologists through DBT skills training.
Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.
Lifestyle alone
Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.
Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.
Control
Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.
No interventions assigned to this group
Interventions
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Dialectical behavioral therapy
Working with psychologists through DBT skills training.
Lifestyle
Working with kinesiologist and registered dietician to improve lifestyle habits.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
17 Years
ALL
Yes
Sponsors
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Diabetes Canada
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Manitoba
OTHER
Responsible Party
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Jon McGavock
Principal Investigator
Locations
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University of Calgary
Calgary, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
McMaster University
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS24295
Identifier Type: -
Identifier Source: org_study_id
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