No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
13 – 18
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
The Miriam Hospital · Other
Who this trial is looking for
This trial is looking for teens with type 1 diabetes who want to improve their health and wellbeing. Participants will take part in a 16-week program specifically designed for teenagers with type 1 diabetes.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with type 1 diabetes for at least 6 months.
My body mass index is at or above the 70th percentile for my age and sex.
I live with a parent or caregiver.
I have access to a smartphone.
I and my caregiver speak and write in fluent English.
You may not be able to join if
I have a medical condition that prevents me from joining group activities or exercising.
I am experiencing psychosis or suicidal thoughts.
I have lost a significant amount of weight in the last 3 months.
I am currently in another intensive health behavior program or see a dietitian more than once a month.
I am currently pregnant or planning to become pregnant.
I am unwilling to wear a continuous glucose monitor for assessments.
I take a medication that impacts my weight or appetite.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 (I…
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.
Trial Locations
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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
Exclusi…
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
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