Healthier Lifestyles for Teens with Type 1 Diabetes
Adapting an Adolescent Weight Management Program for a Type 1 Diabetes Population
We will try a tailored lifestyle program (T1DAL) to help teens with type 1 diabetes who are overweight or at risk of obesity improve their health and reduce risk of disordered eating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | The Miriam Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06878872 on ClinicalTrials.gov |
What this trial studies
This interventional study tests the T1DAL program, an adapted intensive health behavior and lifestyle treatment designed specifically for adolescents with type 1 diabetes. About 50 adolescents who meet eligibility criteria will be enrolled and compared with a usual care control group to measure preliminary effects on weight-related health, glycemic outcomes, and eating disorder risk. The program includes diabetes-specific adaptations such as guidance for managing hypoglycemia around meals and exercise, attention to healthier food choices, and caregiver involvement, and uses smartphone-enabled components and continuous glucose monitor assessments. Outcomes will inform feasibility and whether a larger trial is warranted.
Who should consider this trial
Good fit: Adolescents with type 1 diabetes diagnosed at least six months earlier who have a BMI at or above the 70th percentile for age and sex, live with a parent/caregiver, have a smartphone, and speak and read English.
Not a fit: Those unlikely to benefit include teens with medical limits on group or physical activity, current psychosis or suicidality, recent major weight loss, current enrollment in another intensive lifestyle program, pregnancy or planned pregnancy, unwillingness to wear a continuous glucose monitor, or use of medications that affect weight or appetite.
Why it matters
Potential benefit: If successful, the program could help teens with T1D reduce excess weight, improve metabolic and cardiovascular risk factors, and lower the likelihood of developing disordered eating behaviors.
How similar studies have performed: Intensive lifestyle treatments are proven effective for pediatric obesity, but programs specifically adapted and tested for adolescents with type 1 diabetes and built-in eating disorder prevention remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- Weight Control and Diabetes Research Center — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Jenny Warnick, PhD — The Miriam Hospital
- Study coordinator: Jenny Warnick, PhD
- Email: jwarnick@brownhealth.org
- Phone: 401-793-8757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.