PreventionNCT05338944
Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
A study testing Dialectical behavioral therapy and Lifestyle in people with Prevention and Type2Diabetes, run by University of Manitoba at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention, Type2Diabetes
- What is being tested?
- Dialectical behavioral therapy and Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesCanada
- Study dates
- 14 Jan 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Josephine Ho, MD, 403-955-7003, hoj@ucalgary.ca
Heidi Virtanen, MSc, Heidi.Virtanen@ahs.ca
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Katherine Morrison, MD, FRCP, 905-521-2100 ext. 75926, kmorrison@mcmaster.ca
Autumn Lawrence, MSc, lawrea8@mcmaster.ca
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E3P4
Jonathan McGavock, PhD, 2047893591, jmcgavock@chrim.ca
Jana Apperley, MSc, 2047893591, jslaght@chrim.ca
About this study
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
- Being tested
- Dialectical behavioral therapy, Lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioral therapyBehavioural
Working with psychologists through DBT skills training.
LifestyleBehavioural
Working with kinesiologist and registered dietician to improve lifestyle habits.
| Study group | Role | What they receive |
|---|---|---|
| DBT + lifestyle | Experimental | Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks. Receives: Behavioral: Dialectical behavioral therapy; Behavioral: Lifestyle |
| Lifestyle alone | Experimental | Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks. Receives: Behavioral: Lifestyle |
| Control | No intervention | Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
Measured: 16 weeks
Adherence to the intervention
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Measured: 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: Measured at week 16 and week 32
Secondary outcomes (13)
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
Measured: Measured at baseline, 16 weeks and 32 weeks
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.
Measured: Measured at baseline, 16 weeks and 32 weeks
Body Mass Index (BMI) z-score
Calculated using measured height and weight
Measured: Measured at baseline, 16 weeks and 32 weeks
Emotional regulation
Measurement using the Difficulties in Emotion Regulation Scale (DERS) questionnaire.
Measured: Measured at baseline, 16 weeks and 32 weeks
Emotional reactive eating
Measurement using the Child version of the Three-Factor Eating Questionnaire (TFEQ-R20 C).
Measured: Measured at baseline, 16 weeks and 32 weeks
Depressive symptoms
Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms.
Measured: Measured at baseline, 16 weeks and 32 weeks
Psychological distress
Measured using the Kessler Emotional Distress Scale (K6) to assess psychological distress using six items covering depression and anxiety in the most recent 30 days.
Measured: Measured at baseline, 16 weeks and 32 weeks
Anxiety symptoms
The parent and child version of the Screen for Child Anxiety Related Disorders (SCARED) questionnaire will be used to measure anxiety symptoms.
Measured: Measured at baseline, 16 weeks and 32 weeks
Readiness for Lifestyle Behavior Change
Measured using the PACE readiness questionnaire which assesses readiness for changing dietary habits, daily activity goals and screen time.
Measured: Measured at baseline, 16 weeks and 32 weeks
Behavior regulation in exercise
The BREQ3 (Behavioral Regulation in ExerciseQuestionnaire-3), will be used to measure of the level of motivation to engage in exercise from a self determination perspective.
Measured: Measured at baseline, 16 weeks and 32 weeks
Self-reported healthy lifestyle behaviors - physical activity and screen time
Measured using the CANPWR questionnaire on physical activity and screen time habits.
McPhee PG, Zenlea I, Hamilton JK, Ho J, Ball GDC, Mian R, Buchholz A, Laberge AM, Legault L, Tremblay MS, Chanoine JP, Thabane L, Morrison KM. Individual and family characteristics associated with health indicators at entry into multidisciplinary pediatric weight management: findings from the CANadian Pediatric Weight management Registry (CANPWR). Int J Obes (Lond). 2022 Jan;46(1):85-94. doi: 10.1038/s41366-021-00959-3. Epub 2021 Sep 9. PMID: 34504287.
Measured: Measured at baseline, 16 weeks and 32 weeks
Sleep habits
The Sleep Disturbance Assessment Form (PROMIS) will be used to capture sleep habits.
Measured: Measured at baseline, 16 weeks and 32 weeks
Objective physical activity and sleep patterns
A wrist worn fitbit will collect physical activity data and sleep data for 7 days at each timepoint. Data collected includes: steps per day, minutes of activity in low, moderate and high intensity, and total minutes of sleep per night.
Measured: Measured at baseline, 16 weeks and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start14 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338944
- Sponsor's protocol ID
- HS24295
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 randomised controlled trial in three centres in Canada. BMJ Open. 2026 Feb 12;16(2):e106645. doi: 10.1136/bmjopen-2025-106645.
PubMed 41688123
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
- ClinicalTrials.gov ID
- NCT05338944
- Acronym / sponsor ID
- HS24295
- Conditions
- Prevention, Type2Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Diabetes Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
| Arm | Type | Receives |
|---|---|---|
| DBT + lifestyle | Experimental | Behavioral: Dialectical behavioral therapy, Behavioral: LifestyleParticipants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks. |
| Lifestyle alone | Experimental | Behavioral: LifestyleParticipants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks. |
| Control | No intervention | –Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavioral therapyWorking with psychologists through DBT skills training. | Behavioural | DBT + lifestyle |
| LifestyleWorking with kinesiologist and registered dietician to improve lifestyle habits. | Behavioural | DBT + lifestyle, Lifestyle alone |
Primary outcome
Enrollment rates
Time frame: 16 weeks
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
Time frame: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Retention for follow up measurements
Time frame: Measured at week 16 and week 32
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
13 secondary outcomes
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
Objective physical activity and sleep patterns
Time frame: Measured at baseline, 16 weeks and 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 41688123Cameron 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 randomised controlled trial in three centres in Canada. BMJ Open. 2026 Feb 12;16(2):e106645. doi: 10.1136/bmjopen-2025-106645.
- Individual participant dataSharing planned: Undecided
Related trials for Prevention
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioral therapy and Lifestyle in people with Prevention and Type2Diabetes, run by University of Manitoba at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon McGavock, PhD (204-789-3591, jmcgavock@chrim.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rates (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.