NCT06878872 Type 1 Diabetes Adolescents for Healthier Lifestyles Study
| NCT ID | NCT06878872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Miriam Hospital |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Before the 1990s, obesity was rare among young people with type 1 diabetes (T1D), but now it is more common. Recent studies show that over 50% of young people with T1D will have overweight or obesity within five years of being diagnosed with T1D. Both obesity and T1D increase the risk of heart disease, and combined, these risks are even higher. Intensive health behavior and lifestyle treatments (IHBLTs) are proven to be effective for treating childhood obesity. However, managing T1D creates unique challenges that require adjustments to these treatments. For example, people with T1D need to eat even when they're not hungry to treat low blood sugar, blood sugar changes can make exercise harder, and some recommended "free foods" are high in unhealthy fats. Young people with T1D are also more likely to develop eating disorders. There is a need for IHBLTs that address these specific challenges and focus on preventing eating disorders in this group. To address these needs, we developed the Type 1 Diabetes Adolescents for healthier Lifestyles (T1DAL) program, based on feedback from teenagers with T1D, their parents/caregivers, and pediatric endocrinologists. The goal of this study is to test whether the T1DAL program can improve the health and wellbeing of teens compared to usual care. In this study, about 50 teens will be randomly assigned to either the T1DAL program or to Usual Care. Those in the T1DAL group will take part in a 16-week program designed specifically for teens with T1D to improve eating habits and diabetes management. Those in the Usual Care group will continue with their regular endocrinology appointments. At the end of the study, the Usual Care group will be offered a shortened version of the T1DAL program. All participants will have their height, weight, blood glucose, eating habits, diabetes management behaviors, and mood measured at the start and end of the study. They will also answer questions to track unhealthy eating and weight control behaviors over time. Additional analyses will look at factors that may lead to these behaviors in real life. This project builds on Dr. Warnick's previous work in pediatric obesity and T1D, and it supports the NIDDK's goal of reducing diabetes-related heart problems. T1DAL could become an important public health program to improve the health of teens with T1D.
Eligibility Criteria
Inclusion Criteria: * Teen diagnosed with type 1 diabetes at least 6 months ago * Teen's body mass index greater than or equal to the 70th percentile for age and sex * Teen lives with parent/caregiver * Teen has access to a smart phone * Teen and caregiver speak and write in fluent English Exclusion Criteria: * Teen has a medical condition that precludes them from participating in a group activity and/or any physical activity * Teen experiencing psychosis or suicidality * Teen lost a significant amount of weight in the 3 months prior to the study * Teen currently in another intensive health behavior and lifestyle treatment and/or sees a dietician more than once per month on average * Teen currently or planning to become pregnant * Teen unwilling to wear a continuous glucose monitor for assessments * Teen taking a medication known to impact weight and/or appetite
Contact & Investigator
Jenny Warnick, PhD
PRINCIPAL INVESTIGATOR
The Miriam Hospital
Frequently Asked Questions
Who can join the NCT06878872 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06878872 currently recruiting?
Yes, NCT06878872 is actively recruiting participants. Contact the research team at jwarnick@brownhealth.org for enrollment information.
Where is the NCT06878872 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06878872 clinical trial?
NCT06878872 is sponsored by The Miriam Hospital. The principal investigator is Jenny Warnick, PhD at The Miriam Hospital. The trial plans to enroll 50 participants.
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