Type 1 DiabetesT1DALNCT06878872
Type 1 Diabetes Adolescents for Healthier Lifestyles Study
A study testing T1DAL Program in people with Type 1 Diabetes and Eating Behavior, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Eating Behavior, Adolescent Obesity
- What is being tested?
- T1DAL Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
Jennifer Warnick, PhD, 4017938757, jwarnick@brownhealth.org
About this study
Official title: Adapting an Adolescent Weight Management Program for a Type 1 Diabetes Population
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.
Read more
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.
Read the detailed description
Obesity was rare in youth with type 1 diabetes (T1D) prior to the 1990s, but the prevalence now exceeds that of youth in the general population. Recent studies indicate that over 50% of youth with T1D will develop overweight/obesity within five years of diagnosis. Obesity and T1D are individually associated with risks for cardiovascular disease, and combined, those risks are amplified. Intensive health behavior and lifestyle treatments (IHBLTs) are evidence-based, first-line treatments for pediatric obesity. Yet, there are unique challenges associated with managing T1D that require thoughtful adaptations to these IHBLTs. Challenges include needing to eat regardless of hunger to treat hypoglycemia, blood glucose changes making physical activity difficult, and recommended "free foods" that are high in saturated fats. Adolescents with T1D are also at high risk of developing disordered eating behaviors. There is a critical need for IHBLTs that address barriers specific to T1D and incorporate attention to eating disorder prevention in this at-risk population. Based upon multiple rounds of qualitative feedback from adolescents with T1D, their caregivers, and pediatric endocrinologists, our team developed the Type 1 Diabetes Adolescents for healthier Lifestyles (T1DAL) Study. The objective of this study is to test whether the T1DAL program preliminarily improves adolescents' health and wellbeing compared to a usual care control group.
In this study, approximately 50 total adolescents will be randomly assigned either to the T1DAL program or to Usual Care. Adolescents randomized to the T1DAL program will complete a 16-week IHBLT adapted to a T1D population. Those randomized to Usual Care will attend their routine endocrinology appointments. At the end of the study, those assigned to Usual Care will be offered an abbreviated T1DAL program. All adolescents' height, weight, time in target blood glucose range (70-180mg/dL), eating behaviors, diabetes management behaviors, and mood will be assessed at the start and end of study involvement. Participants will also complete ecological momentary assessments (EMA) at the start and end of study involvement to determine potential events of maladaptive eating and weight control behaviors over time. Exploratory analyses will evaluate correlates of these maladaptive eating and weight control behaviors in real-world settings.
This project builds upon Dr. Warnick's prior work in pediatric obesity and T1D. The proposed project aligns with the NIDDK's mission to mitigate diabetes-related cardiovascular events and has the potential to be an important public health intervention to improve the health of adolescents with T1D.
- Conditions
- Type 1 Diabetes, Eating Behavior, Adolescent Obesity
- Being tested
- T1DAL Program
- Keywords
- Teenagers, Diabetes, Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Feeding Behavior, Pediatric Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1DAL ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| T1DAL Program | Experimental | Adolescent intensive health behavior and lifestyle treatment adapted for a type 1 diabetes population Receives: Behavioral: T1DAL Program |
| Usual Care | No intervention | Adolescents continue their typical diabetes treatment management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Change
Change in body mass index
Measured: baseline, 4-months
Time in Range Change
Change in time in the recommended glucose range (70-180 mg/dL)
Measured: baseline, 4-months
Secondary outcomes (1)
Events of Unhealthy Weight Control Behaviors
Events of maladaptive/disordered weight-control behaviors
Measured: baseline, 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Aug 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Warnick, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878872
- Sponsor's protocol ID
- 5K23DK132457
- Other IDs
- 5K23DK132457
- Acronym
- T1DAL
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact the PI for a request of de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Adolescent Weight Management Program for a Type 1 Diabetes Population
- ClinicalTrials.gov ID
- NCT06878872
- Acronym / sponsor ID
- T1DAL / 5K23DK132457
- Conditions
- Type 1 Diabetes, Eating Behavior, Adolescent Obesity
- Keywords
- Teenagers, Diabetes, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity was rare in youth with type 1 diabetes (T1D) prior to the 1990s, but the prevalence now exceeds that of youth in the general population. Recent studies indicate that over 50% of youth with T1D will develop overweight/obesity within five years of diagnosis. Obesity and T1D are individually associated with risks for cardiovascular disease, and combined, those risks are amplified. Intensive health behavior and lifestyle treatments (IHBLTs) are evidence-based, first-line treatments for pediatric obesity. Yet, there are unique challenges associated with managing T1D that require thoughtful adaptations to these IHBLTs. Challenges include needing to eat regardless of hunger to treat hypoglycemia, blood glucose changes making physical activity difficult, and recommended "free foods" that are high in saturated fats. Adolescents with T1D are also at high risk of developing disordered eating behaviors. There is a critical need for IHBLTs that address barriers specific to T1D and incorporate attention to eating disorder prevention in this at-risk population. Based upon multiple rounds of qualitative feedback from adolescents with T1D, their caregivers, and pediatric endocrinologists, our team developed the Type 1 Diabetes Adolescents for healthier Lifestyles (T1DAL) Study. The objective of this study is to test whether the T1DAL program preliminarily improves adolescents' health and wellbeing compared to a usual care control group.
In this study, approximately 50 total adolescents will be randomly assigned either to the T1DAL program or to Usual Care. Adolescents randomized to the T1DAL program will complete a 16-week IHBLT adapted to a T1D population. Those randomized to Usual Care will attend their routine endocrinology appointments. At the end of the study, those assigned to Usual Care will be offered an abbreviated T1DAL program. All adolescents' height, weight, time in target blood glucose range (70-180mg/dL), eating behaviors, diabetes management behaviors, and mood will be assessed at the start and end of study involvement. Participants will also complete ecological momentary assessments (EMA) at the start and end of study involvement to determine potential events of maladaptive eating and weight control behaviors over time. Exploratory analyses will evaluate correlates of these maladaptive eating and weight control behaviors in real-world settings.
This project builds upon Dr. Warnick's prior work in pediatric obesity and T1D. The proposed project aligns with the NIDDK's mission to mitigate diabetes-related cardiovascular events and has the potential to be an important public health intervention to improve the health of adolescents with T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1DAL Program | Experimental | Behavioral: T1DAL ProgramAdolescent intensive health behavior and lifestyle treatment adapted for a type 1 diabetes population |
| Usual Care | No intervention | –Adolescents continue their typical diabetes treatment management. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1DAL ProgramT1DAL 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. | Behavioural | T1DAL Program |
Primary outcome
BMI Change
Time frame: baseline, 4-months
Change in body mass index
Time in Range Change
Time frame: baseline, 4-months
Change in time in the recommended glucose range (70-180 mg/dL)
1 secondary outcome
Events of Unhealthy Weight Control Behaviors
Time frame: baseline, 4-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Please contact the PI for a request of de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Warnick, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1DAL Program in people with Type 1 Diabetes and Eating Behavior, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Warnick, PhD (401-793-8757, jwarnick@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Change (time frame: baseline, 4-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.