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Recruiting NCT05338944

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

No phase Interventional Prevention Type2Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dialectical behavioral therapy, Lifestyle.
Who it may be relevant to
Registry conditions: Prevention, Type2Diabetes. Basic parameters: 14 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Enrollment rates [Time frame: 16 weeks]
  • Adherence to the intervention [Time frame: 16 weeks]
  • Retention for follow up measurements [Time frame: Measured at week 16 and week 32]
Secondary outcome measures (12)
  • Quality of Life measure using the PedsQL questionnaire [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Body composition measured by dual-x-ray absorptiometry (DXA) [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Body Mass Index (BMI) z-score [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Emotional regulation [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Emotional reactive eating [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Depressive symptoms [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Psychological distress [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Anxiety symptoms [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Readiness for Lifestyle Behavior Change [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Behavior regulation in exercise [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Self-reported healthy lifestyle behaviors - physical activity and screen time [Time frame: Measured at baseline, 16 weeks and 32 weeks]
  • Sleep habits [Time frame: Measured at baseline, 16 weeks and 32 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 3 centers
  • University of Calgary — Calgary
  • University of Manitoba — Winnipeg
  • McMaster University — Hamilton

Publications

  • Cameron EE, Morrison KM, Ho J, Roos L, Katz L, Mushquash A, Dart A, Wicklow BA, Senechal M, Jung ME, Strachan SM, Afifi TO, Archibald M, Andrade B, Hadjiyannakis S, Hamilton J, Slaght J, Penner K, Balshaw RF, McGavock J. Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot PMID 41688123

Identifiers

NCT: NCT05338944 · HS24295

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗