Recruiting

Lifestyle + DBT

Sponsor:

University of Manitoba

Code:

NCT05338944

Conditions

Prevention

Type2Diabetes

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

Interventions

Dialectical behavioral therapy

Lifestyle

Study Details

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.

Conditions

Prevention

Type2Diabetes

Study ID

NCT05338944

Start date

Jan 14, 2023

Status verified date

Sep, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DBT + lifestyle

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

experimental: Lifestyle alone

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

no intervention: Control

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

Interventions

Dialectical behavioral therapy

Working with psychologists through DBT skills training.

Lifestyle

Working with kinesiologist and registered dietician to improve lifestyle habits.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jon McGavock, PhD

204-789-3591jmcgavock@chrim.ca

Jana Slaght, MSc

204-789-3591jslaght@chrim.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Josephine Ho, MD

403-955-7003hoj@ucalgary.ca

Heidi Virtanen, MSc

Heidi.Virtanen@ahs.ca

Principal Investigator:

Josephine Ho, MD

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E3P4

Contacts

Jonathan McGavock, PhD

2047893591jmcgavock@chrim.ca

Jana Apperley, MSc

2047893591jslaght@chrim.ca

Principal Investigator:

Jonathan McGavock, PhD

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Katherine Morrison, MD, FRCP

905-521-2100kmorrison@mcmaster.ca

Autumn Lawrence, MSc

lawrea8@mcmaster.ca

Principal Investigator:

Katherine Morrison, MD, FRCP

More Information

Sponsor

University of Manitoba

Last update posted

Oct 7, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-10-07.