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Type 1 Diabetes Adolescents for Healthier Lifestyles Study

Adapting an Adolescent Weight Management Program for a Type 1 Diabetes Population

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether T1DAL, a 16-week program on eating habits and diabetes care, improves teens' health and well-being compared with usual care. It is for teens with type 1 diabetes whose body mass index (BMI), a measure based on height and weight, is at or above the 70th percentile for their age and sex.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Was diagnosed with type 1 diabetes at least 6 months ago.
  • Has a BMI at or above the 70th percentile—equal to or higher than about 70 out of 100 teens of the same age and sex.
  • Lives with a parent or caregiver.
  • Has access to a smartphone.
  • Both the teen and caregiver speak and write English fluently.

Who can't join

  • Has a health condition that prevents joining group activities or doing physical activity.
  • Has psychosis (trouble knowing what is real) or suicidal thoughts or actions.
  • Lost a large amount of weight in the past 3 months.
  • Is in another intensive healthy habits and lifestyle program, or sees a dietitian (a food and nutrition expert) more than once a month on average.
  • Is pregnant or plans to become pregnant.
  • Is not willing to wear a continuous glucose monitor, a device that tracks blood sugar, for study checks.
  • Takes medicine known to affect weight or appetite.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

RI