Lifestyle alone for Prevention

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Manitoba, Winnipeg, Canada
Prevention+3 More
Dialectical behavioral therapy - Behavioral
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

1 of 3

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

1 of 3

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: Behavioral
DBT + 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

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.