Mobile health intervention to promote physical activity in youth with Type 1 diabetes
Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
This study is testing if sending text messages can help young people with Type 1 diabetes be more active and improve their health over three weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06018844 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a mobile health (mHealth) intervention designed to increase physical activity among youth diagnosed with Type 1 Diabetes Mellitus. Participants aged 12 to 21 will receive text messages from the Nudge software to encourage moderate to vigorous physical activity (MVPA) and will track their activity using wearable devices over a three-week period. The study will assess whether increased communication through text messages correlates with improved physical activity levels and better HbA1c outcomes. Participants will also complete surveys to report their physical activity goals and experiences throughout the study.
Who should consider this trial
Good fit: Ideal candidates are youth aged 12 to 21 with a confirmed diagnosis of Type 1 diabetes for at least six months and who are using a continuous glucose monitor.
Not a fit: Patients with type 2 diabetes, severe psychiatric disorders, or those unable to engage in physical activity due to mobility issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved physical activity levels and better diabetes management for youth with Type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using mobile health interventions to improve health outcomes in chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants 12.00-21.99 years old * Participants with a physician confirmed T1D diagnosis. * T1D diagnosis was at least 6 months prior to study enrollment * Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection) * Participants must be using a continuous glucose monitor (CGM) * Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English. Exclusion Criteria: * Participants with evidence of type 2 or monogenic diabetes. * Participants with a comorbid chronic condition (e.g., renal disease). * Participants with presence of severe psychiatric disorders. * Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses). * Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.
Where this trial is running
Kansas City, Missouri
- Children's Mercy — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Mark Clements, MD — Children's Mercy
- Study coordinator: Claire Petty
- Email: ckpetty@cmh.edu
- Phone: 816-601-4546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.