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Physical Activity Program for Type 1 Diabetes (Activate Trial)

N/A
Waitlist Available
Led By Amy Hughes Lansing, PhD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to complete measures and intervention program in English
Aged 13-17 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 and week 12
Awards & highlights

Activate Trial 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.

Who is the study for?
This trial is for U.S. teens aged 13-17 with Type 1 Diabetes diagnosed at least 18 months ago, who speak English and have internet access. They should be moderately inactive based on parent reports. Teens with severe medical or psychiatric conditions, contraindications to physical activity, or under state custody cannot participate.Check my eligibility
What is being tested?
The study tests 'Activate', a technology-delivered program combining diabetes behavior-change skills training with a physical activity promotion over 12 weeks. It's compared against usual treatments to see if it improves daily activity levels and reduces health disparities in adolescents with Type 1 Diabetes.See study design
What are the potential side effects?
Since this trial focuses on education and exercise programs rather than medication, typical drug side effects are not expected. However, participants may experience fatigue or discomfort from increased physical activity.

Activate Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can complete tasks and follow the program in English.
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I am between 13 and 17 years old.

Activate Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Coping Skills Assessed by the Coping Self-Efficacy Scale
Change from Baseline in Goal Setting Assessed by Goal-Directed Planning
Change from Baseline in Physical Activity
Secondary outcome measures
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
+20 more

Activate Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
This arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals.
Group II: Treatment as usual - ControlActive Control1 Intervention
This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes behavior change skills training
2022
N/A
~30
Physical activity promotion program
2022
N/A
~30

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
270 Previous Clinical Trials
3,743,765 Total Patients Enrolled
Amy Hughes Lansing, PhDPrincipal InvestigatorUniversity of Vermont

Media Library

Diabetes behavior change skills training Clinical Trial Eligibility Overview. Trial Name: NCT05319600 — N/A
Type 1 Diabetes Research Study Groups: Treatment as usual - Control, Intervention
Type 1 Diabetes Clinical Trial 2023: Diabetes behavior change skills training Highlights & Side Effects. Trial Name: NCT05319600 — N/A
Diabetes behavior change skills training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05319600 — N/A
~9 spots leftby Jun 2025
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