Recruiting

T1DAL Program

Sponsor:

The Miriam Hospital

Code:

NCT06878872

Conditions

Type 1 Diabetes

Eating Behavior

Adolescent Obesity

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

T1DAL Program

Study Details

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.

Conditions

Type 1 Diabetes

Eating Behavior

Adolescent Obesity

Study ID

NCT06878872

Start date

Aug 1, 2025

Status verified date

Mar, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

T1DAL Program

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

More Information

Sponsor

The Miriam Hospital

Last update posted

May 13, 2026

Last verified

Mar, 2026

Keywords

  • Teenagers
  • Diabetes
  • Type 1 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2026-05-13.