Type 1 Diabetes Adolescents for Healthier Lifestyles Study

NCT06878872 | Not Yet Recruiting

• 1 other identifier: 5K23DK132457
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Teenagers; Diabetes; Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• BMI Change

  Change in body mass index

  baseline, 4-months

• Time in Range Change

  Change in time in the recommended glucose range (70-180 mg/dL)

  baseline, 4-months

Secondary Outcomes (1)

• Events of Unhealthy Weight Control Behaviors

  baseline, 4-months

Other Outcomes (1)

• Correlates of Unhealthy Weight Control Behaviors

  baseline, 4-months

Study Arms (2)

T1DAL Program

EXPERIMENTAL

Adolescent intensive health behavior and lifestyle treatment adapted for a type 1 diabetes population

Behavioral: T1DAL Program

Usual Care

NO INTERVENTION

Adolescents continue their typical diabetes treatment management.

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.

T1DAL Program

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding Behavior; Pediatric Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior, Animal; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jenny Warnick, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Warnick, PhD

CONTACT

401-793-8757; jwarnick@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share