Health TrialsbyHealthPanel

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

ConditionsPreventionType2Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-17
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

more than one health co-morbidity

being treated with medication for obesity

taking steroids

currently being treated for atypical antipsychotics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dialectical behavioral therapy

    Behavioral

    Working with psychologists through DBT skills training.

  • Lifestyle

    Behavioral

    Working with kinesiologist and registered dietician to improve lifestyle habits.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: DBT + lifestyleExperimental treatment 2 interventions
Group B: Lifestyle aloneExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Enrollment rates

defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study

Time frame
16 weeks
2

Adherence to the intervention

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

Time frame
16 weeks
3

Retention for follow up measurements

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

Time frame
Measured at week 16 and week 32

Secondary outcomes

1

Quality of Life measure using the PedsQL questionnaire

Measure using the PedsQL questionnaire, subscales of emotional, social and health-related QOL will be treated separately and as a composite measure

Time frame
Measured at baseline, 16 weeks and 32 weeks
2

Body composition measured by dual-x-ray absorptiometry (DXA)

Measurements of % body fat, total fat, trunk fat, muscle mass, estimated VAT mass, estimated VAT volume and estimated VAT area will be collected, along with height and weight.

Time frame
Measured at baseline, 16 weeks and 32 weeks
3

Body Mass Index (BMI) z-score

Calculated using measured height and weight

Time frame
Measured at baseline, 16 weeks and 32 weeks
4

Emotional regulation

Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire.

Time frame
Measured at baseline, 16 weeks and 32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Diabetes Canada

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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