Lifestyle alone for Prevention
Phase-Based Progress Estimates
Effectiveness
Safety
University of Manitoba, Winnipeg, Canada
Prevention+3 More
Dialectical behavioral therapy - BehavioralEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
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Study 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.
Eligible Conditions
- Prevention
- Type2Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: one week at week 16 and week 32
16 weeks
Adherence to the intervention
Week 16
Barriers for lifestyle change
DBT benefits and challenges
DBT skills training
Delivery of behavioral intervention
Feedback
Patient centered
6 weeks
Enrollment rates
Week 32
Retention for follow up measurements
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Control
1 of 3
Lifestyle alone
1 of 3
DBT + lifestyle
1 of 3
Active Control
Experimental Treatment
15 Total Participants · 3 Treatment Groups
Primary Treatment: Lifestyle alone · No Placebo Group · N/A
Lifestyle alone
Behavioral
Experimental Group · 1 Intervention: Lifestyle · Intervention Types: BehavioralDBT + lifestyleExperimental Group · 2 Interventions: Dialectical behavioral therapy, Lifestyle · Intervention Types: Behavioral, Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dialectical behavioral therapy
2019
N/A
~30
Lifestyle
2016
Completed Phase 4
~3220
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one week at week 16 and week 32
Closest Location: University of Manitoba · Winnipeg, Canada
2001First Recorded Clinical Trial
1 TrialsResearching Prevention
128 CompletedClinical Trials
Eligibility Criteria
Age < 18 · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have 5-19 PHQ-9 score.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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