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DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

Primary Purpose

Prevention, Type2Diabetes

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dialectical behavioral therapy
Lifestyle
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 14-17 years old
  • BMI z-score >1.6
  • 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
  • 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/unwilling to give assent/consent

Sites / Locations

  • University of Calgary
  • University of Manitoba
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

DBT + lifestyle

Lifestyle alone

Control

Arm Description

Participants will receive 90 minutes of dialectical behavioral therapy and 60 minutes of lifestyle sessions each week for 16 weeks.

Participants will receive 2 lifestyle sessions per week, one 90 minutes in length and the other 60 minutes for 16 weeks.

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

Outcomes

Primary Outcome Measures

Enrollment rates
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 intervention
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Retention for follow up measurements
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks

Secondary Outcome Measures

Barriers for lifestyle change
What are the barriers for lifestyle change for adolescents. Collected through focus groups and photovoice participation at 16 weeks.
Delivery of behavioral intervention
What are the preferred intervention attributes for delivering a behavioral intervention? Collected from focus groups and feedback forms.
DBT skills training
How appropriate is DBT skills training for adolescents and their families? Collected from focus groups and feedback forms.
DBT benefits and challenges
What are the perceived benefits and challenges associated with DBT-enhanced intensive lifestyle therapy? Collected from focus groups and feedback forms.
Patient centered
How patient-centered are the proposed tools for assessing mental health co-morbidities and self-regulation? Collected from focus groups and feedback forms.
Feedback
What other outcomes should we consider measuring? Collected from focus groups and feedback forms.

Full Information

First Posted
April 6, 2022
Last Updated
March 13, 2023
Sponsor
University of Manitoba
Collaborators
Diabetes Canada, Children's Hospital Research Institute of Manitoba (CHRIM)
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1. Study Identification

Unique Protocol Identification Number
NCT05338944
Brief Title
DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity
Official Title
Dialectal Behavioural Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Diabetes Canada, Children's Hospital Research Institute of Manitoba (CHRIM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention, Type2Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBT + lifestyle
Arm Type
Experimental
Arm Description
Participants will receive 90 minutes of dialectical behavioral therapy and 60 minutes of lifestyle sessions each week for 16 weeks.
Arm Title
Lifestyle alone
Arm Type
Experimental
Arm Description
Participants will receive 2 lifestyle sessions per week, one 90 minutes in length and the other 60 minutes for 16 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavioral therapy
Intervention Description
Working with psychologists through DBT skills training.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Intervention Description
Working with kinesiologist and registered dietician to improve lifestyle habits.
Primary Outcome Measure Information:
Title
Enrollment rates
Description
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
Time Frame
6 weeks
Title
Adherence to the intervention
Description
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Time Frame
16 weeks
Title
Retention for follow up measurements
Description
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
Time Frame
one week at week 16 and week 32
Secondary Outcome Measure Information:
Title
Barriers for lifestyle change
Description
What are the barriers for lifestyle change for adolescents. Collected through focus groups and photovoice participation at 16 weeks.
Time Frame
2 weeks at 16 weeks
Title
Delivery of behavioral intervention
Description
What are the preferred intervention attributes for delivering a behavioral intervention? Collected from focus groups and feedback forms.
Time Frame
2 weeks at 16 weeks
Title
DBT skills training
Description
How appropriate is DBT skills training for adolescents and their families? Collected from focus groups and feedback forms.
Time Frame
2 weeks at 16 weeks
Title
DBT benefits and challenges
Description
What are the perceived benefits and challenges associated with DBT-enhanced intensive lifestyle therapy? Collected from focus groups and feedback forms.
Time Frame
2 weeks at 16 weeks
Title
Patient centered
Description
How patient-centered are the proposed tools for assessing mental health co-morbidities and self-regulation? Collected from focus groups and feedback forms.
Time Frame
2 weeks at 16 weeks
Title
Feedback
Description
What other outcomes should we consider measuring? Collected from focus groups and feedback forms.
Time Frame
2 weeks at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 14-17 years old BMI z-score >1.6 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 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/unwilling to give assent/consent
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3P4
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

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