Actively Recruiting
Type 1 Diabetes Adolescents for Healthier Lifestyles Study
Led by The Miriam Hospital · Updated on 2026-05-13
50
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
T
The Miriam Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Type 1 Diabetes Adolescents for Healthier Lifestyles Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Teen has a medical condition that prevents participation in group or physical activities
- Teen experiencing psychosis or suicidality
- Teen lost significant weight in the 3 months before the study
- Teen currently in another intensive health behavior and lifestyle treatment or sees a dietician more than once per month
- Teen currently pregnant or planning to become pregnant
- Teen unwilling to wear a continuous glucose monitor for assessments
- Teen taking medication known to affect weight or appetite
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
J
Jenny Warnick, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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