NCT05338944

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2023Jan 2027

First Submitted

Initial submission to the registry

April 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 14, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

April 6, 2022

Last Update Submit

October 2, 2025

Conditions

PreventionType2Diabetes

Outcome Measures

Primary Outcomes (3)

  • Enrollment rates

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

    16 weeks

  • Adherence to the intervention

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

    16 weeks

  • Retention for follow up measurements

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

    Measured at week 16 and week 32

Secondary Outcomes (13)

  • Quality of Life measure using the PedsQL questionnaire

    Measured at baseline, 16 weeks and 32 weeks

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

    Measured at baseline, 16 weeks and 32 weeks

  • Body Mass Index (BMI) z-score

    Measured at baseline, 16 weeks and 32 weeks

  • Emotional regulation

    Measured at baseline, 16 weeks and 32 weeks

  • Emotional reactive eating

    Measured at baseline, 16 weeks and 32 weeks

  • +8 more secondary outcomes

Study Arms (3)

DBT + lifestyle

EXPERIMENTAL

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

Behavioral: Dialectical behavioral therapyBehavioral: Lifestyle

Lifestyle alone

EXPERIMENTAL

Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.

Behavioral: Lifestyle

Control

NO INTERVENTION

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

Interventions

Dialectical behavioral therapyBEHAVIORAL

Working with psychologists through DBT skills training.

DBT + lifestyle
LifestyleBEHAVIORAL

Working with kinesiologist and registered dietician to improve lifestyle habits.

DBT + lifestyleLifestyle alone

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3E3P4, Canada

RECRUITING

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Central Study Contacts

Jon McGavock, PhD

CONTACT

204-789-3591jmcgavock@chrim.ca

Jana Slaght, MSc

CONTACT

204-789-3591jslaght@chrim.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 21, 2022

Study Start

January 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

October 7, 2025

Record last verified: 2025-09

Locations

CA(3)