Type 1 Diabetes Adolescents for Healthier Lifestyles Study

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT06878872
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • T1DAL Program — BEHAVIORAL
    T1DAL is a 16-week behavioral program. Teens meet in virtual groups and individually with a health coach throughout the program. Teens learn healthy lifestyle behaviors specific to living with type 1 diabetes and get opportunities to connect with other teens who are living with type 1 diabetes.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: T1DAL Program
    Adolescent intensive health behavior and lifestyle treatment adapted for a type 1 diabetes population
  • No Intervention: Usual Care
    Adolescents continue their typical diabetes treatment management.

Primary Outcome Measure

BMI Change [ Time Frame: baseline, 4-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weight Control and Diabetes Research CenterProvidenceRhode Island02903
Jennifer Warnick, PhD
[email protected]
4017938757

Find similar trials in Providence, RI

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Weight Control and Diabetes Research Center· Providence, RI

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