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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

At least 18 months post-diagnosis for type 1 diabetes

Ability to complete measures and intervention program in English

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 was diagnosed with type 1 diabetes over 18 months ago.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 and week 12

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor

266 Previous Clinical Trials

3,743,661 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the fundamental purpose of this research endeavor?

"The primary purpose of this 12-week clinical trial is to quantify changes in coping skills utilizing the Coping Self-Efficacy Scale. Secondary objectives include observing shifts in distress, as quantified by the Patient Health Questionnaire for Adolescents (PHQ-A), self regulation procured from the Effortful Control Short Scale, and perceived stress calculated via Perceived Stress Scale (PSS)."

Answered by AI

What criteria makes someone an ideal participant for this research?

"This medical trial is enrolling 30 adolescents aged 13-17 with diabetes and autoimmune conditions. To be considered, applicants must have moderate to no physical activity reported by a parent, understand English, possess access to the internet either through broadband or cellular network, obtain healthcare in America and have been diagnosed for over 18 months if they are type 1 diabetics."

Answered by AI

Is enrollment for this research endeavor still available to individuals?

"Clinicaltrials.gov affirms that this medical trial, which was originally posted on March 23rd 2022, is currently enrolling participants. The data has been updated as recently as April 5th of the same year."

Answered by AI

What is the quota for enrollees in this clinical trial?

"Affirmative. As outlined on clinicaltrials.gov, this research project is still seeking applicants; the trial was initially launched on March 23rd 2022 and has since been updated on April 5th 2022. 30 participants need to be recruited from 1 location at this time."

Answered by AI