Diabetes behavior change skills training for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 1 DiabetesDiabetes behavior change skills training - Behavioral
Eligibility
13 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a 12-week program to help adolescents with type 1 diabetes improve their behavior-change skills and get more active minutes every day. The goal is to see if the program is acceptable and effective, and if it improves other mechanisms and outcomes linked with later type 1 diabetes health disparities.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

3 Primary · 23 Secondary · Reporting Duration: week 1 and week 12

Week 12
Change from Baseline in Physical Activity
Week 12
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Pressure
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Sugar
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Diet
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Physical Activity
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Total Cholesterol
Change from Baseline in Cardiovascular Disease Risk Score Assessed by Weight
Change from Baseline in Coping Skills Assessed by the Coping Self-Efficacy Scale
Change from Baseline in Diet and Physical Activity Habit Strength Assessed by the Eating and Activity Behavioral Automaticity Scale (EABA)
Change from Baseline in Distress Assessed by the Diabetes Stress Questionnaire - Short Form (DSQ)
Change from Baseline in Distress Assessed by the Motivation and Energy Inventory (MEI)
Change from Baseline in Distress Assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)
Change from Baseline in Distress Assessed by the Pediatric Symptom Checklist (PSC-17)
Change from Baseline in Distress Assessed by the Perceived Stress Scale (PSS)
Change from Baseline in Distress Assessed by the Type 1 Diabetes Quality of Life (T1DAL) Measure
Change from Baseline in Glycosylated Hemoglobin (HbA1c) Percentage
Change from Baseline in Goal Setting Assessed by Goal-Directed Planning
Change from Baseline in Inflammation Assessed by C-Reactive Protein
Change from Baseline in Mean Daily Blood Glucose (MBG)
Change from Baseline in Mean Variability in Blood Glucose
Change from Baseline in Self-Regulation Assessed by The Functional Assessment of Maladaptive Behaviors
Change from Baseline in Self-Regulation Assessed by the Delay Discounting Task
Change from Baseline in Self-Regulation Assessed by the Diabetes Habit Strength (DHS) Measure
Change from Baseline in Self-Regulation Assessed by the Effortful Control Scale Short
Change from Baseline in Self-Regulation Assessed by the Self Care Inventory (SCI)
Change in insulin requirements

Trial Safety

Trial Design

2 Treatment Groups

Treatment as usual - Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Diabetes behavior change skills training · No Placebo Group · N/A

InterventionExperimental Group · 2 Interventions: Physical activity promotion program, Diabetes behavior change skills training · Intervention Types: Behavioral, Behavioral
Treatment as usual - ControlNoIntervention Group · 1 Intervention: Treatment as usual - Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 1 and week 12

Who is running the clinical trial?

University of VermontLead Sponsor
254 Previous Clinical Trials
3,742,785 Total Patients Enrolled
Amy Hughes Lansing, PhDPrincipal InvestigatorUniversity of Vermont

Eligibility Criteria

Age 13 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum age of 13 years old.
You have had diabetes for at least 18 months.
References