Type1diabetesNCT03531021
Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes
A study testing Heart healthy intervention in people with Type1diabetes and Cardiovascular Risk Factor, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Type1diabetes, Cardiovascular Risk Factor
- What is being tested?
- Heart healthy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 8 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Teens ages 14-19 years old with T1D for ≥6 months
- Current patients at Joslin Diabetes Center
- Teens will have dyslipidemia (defined as LDL ≥100 mg/dl, HDL <40 mg/dl or triglycerides ≥130 mg/dl in past year), overweight or obesity (BMI percentile ≥85th at screening), prehypertensive or hypertensive blood pressure on day of screening visit, or A1c ≥8.0%
- Youth and parents must be English speaking, without significant learning disabilities, and intend to continue care at our center.
- Access to a smart phone with video conferencing capabilities
Who cannot join
- Participation in an interventional study within the past 3 months.
- Unwilling to comply with study procedures
- Prescribed BP and/or lipid-lowering medications (besides over-the-counter supplements)
- Contraindication to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.
Read the detailed description
Specific Aim: To develop and pilot test a modular intervention to improve heart healthy self-efficacy and behaviors in teens with type 1 diabetes at elevated cardiovascular disease risk.
Intervention Objective: To evaluate the feasibility and efficacy of a psychoeducational and behavioral intervention to improve heart healthy self-efficacy and behaviors in youth with type 1 diabetes (T1D) at elevated cardiovascular disease (CVD) CVD risk.
Secondary Objective: Assess participation in challenges involving healthy eating and physical activity.
Synopsis of Study Design
Study Design: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
Study Population: Teens with type 1 diabetes.
Intervention: This pilot study involves a 6-month randomized controlled trial (RCT) comparing 2 study conditions, the behavioral intervention vs. an attention control. Youth will be randomized in 2 strata, by age (14-16 years and 17-19 years). Enrollment will end after 60 participants.
The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Challenges will occur every 2 weeks. Participants will be on teams of about 3-5 teens and the teams may change over the course of the intervention due to staggered enrollment. As team members finish the study, newly randomized teammates will be assigned.
There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the research assistants (RAs) for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.
- Conditions
- Type1diabetes, Cardiovascular Risk Factor
- Being tested
- Heart healthy intervention
- Keywords
- type 1 diabetes, cardiovascular risk factor, teenager
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart healthy interventionBehavioural
Intervention consists of educational modules, goal setting and brainstorming around strategies and barriers, and a series of heart healthy challenges such as walking a certain number of steps or eating healthy foods a certain number of times in a week.
| Study group | Role | What they receive |
|---|---|---|
| Heart healthy intervention | Experimental | The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Participants will be placed on teams and encouraged to complete behavioral challenges to earn points towards a cash reward. Receives: Behavioral: Heart healthy intervention |
| Attention Control | No intervention | There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the RAs for demographic and survey completion and receive reminder phone calls/emails in order to match for attention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Food Habits Checklist
healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.
Measured: 3 months
Secondary outcomes (10)
Adiposity
changes in zbmi
Measured: 3 months
Blood pressure
Changes in blood pressure percentile
Measured: 3 months
Changes in lipid levels
Changes in lipid levels from before study until study end
Measured: 3 months
Activity level
Documentation of how active participants were during study
Measured: 3 months
Exercise Confidence Survey
evaluation of self-efficacy for exercise
Measured: 3 months
Healthy Eating Self-Efficacy Survey
healthy eating self-efficacy measure
Measured: 3 months
Eating Habits Confidence Survey
evaluation of how confident participants are that they can eat in a healthy way
Measured: 3 months
Acceptance of medication for CVD risk survey
brief questions to evaluate willingness to take medication if prescribed
Measured: 3 months
Engagement with behavioral challenges
Proportion of intervention participants who completed challenges
Measured: 3 months
Change in weight
change in weight in kg between enrollment and study completion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start3 May 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Laffel, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531021
- Sponsor's protocol ID
- 2017-34
- Status last verified
- Aug 2021
- First submitted
- 26 Apr 2018
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maxwell TK, Charmant CO, Volkening LK, Laffel LM, Katz ML. A Randomized Pilot Trial Using Mobile Health and Financial Incentives to Motivate Heart-Healthy Behaviors in Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 May;17(3):855-856. doi: 10.1177/19322968231155151. Epub 2023 Feb 23. No abstract available.
PubMed 36824050
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT03531021
- Acronym / sponsor ID
- 2017-34
- Conditions
- Type1diabetes, Cardiovascular Risk Factor
- Keywords
- type 1 diabetes, cardiovascular risk factor, teenager
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 21 May 2018 (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.
This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.
Detailed description
Specific Aim: To develop and pilot test a modular intervention to improve heart healthy self-efficacy and behaviors in teens with type 1 diabetes at elevated cardiovascular disease risk.
Intervention Objective: To evaluate the feasibility and efficacy of a psychoeducational and behavioral intervention to improve heart healthy self-efficacy and behaviors in youth with type 1 diabetes (T1D) at elevated cardiovascular disease (CVD) CVD risk.
Secondary Objective: Assess participation in challenges involving healthy eating and physical activity.
Synopsis of Study Design
Study Design: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
Study Population: Teens with type 1 diabetes.
Intervention: This pilot study involves a 6-month randomized controlled trial (RCT) comparing 2 study conditions, the behavioral intervention vs. an attention control. Youth will be randomized in 2 strata, by age (14-16 years and 17-19 years). Enrollment will end after 60 participants.
The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Challenges will occur every 2 weeks. Participants will be on teams of about 3-5 teens and the teams may change over the course of the intervention due to staggered enrollment. As team members finish the study, newly randomized teammates will be assigned.
There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the research assistants (RAs) for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).
| Arm | Type | Receives |
|---|---|---|
| Heart healthy intervention | Experimental | Behavioral: Heart healthy interventionThe intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Participants will be placed on teams and encouraged to complete behavioral challenges to earn points towards a cash reward. |
| Attention Control | No intervention | –There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the RAs for demographic and survey completion and receive reminder phone calls/emails in order to match for attention. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Teens ages 14-19 years old with T1D for ≥6 months
- Current patients at Joslin Diabetes Center
- Teens will have dyslipidemia (defined as LDL ≥100 mg/dl, HDL <40 mg/dl or triglycerides ≥130 mg/dl in past year), overweight or obesity (BMI percentile ≥85th at screening), prehypertensive or hypertensive blood pressure on day of screening visit, or A1c ≥8.0%
- Youth and parents must be English speaking, without significant learning disabilities, and intend to continue care at our center.
- Access to a smart phone with video conferencing capabilities
Key exclusion criteria (4 listed)
- Participation in an interventional study within the past 3 months.
- Unwilling to comply with study procedures
- Prescribed BP and/or lipid-lowering medications (besides over-the-counter supplements)
- Contraindication to exercise
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 |
|---|---|---|
| Heart healthy interventionIntervention consists of educational modules, goal setting and brainstorming around strategies and barriers, and a series of heart healthy challenges such as walking a certain number of steps or eating healthy foods a certain number of times in a week. | Behavioural | Heart healthy intervention |
Primary outcome
Adolescent Food Habits Checklist
Time frame: 3 months
healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.
10 secondary outcomes
Adiposity
Time frame: 3 months
Blood pressure
Time frame: 3 months
Changes in lipid levels
Time frame: 3 months
Activity level
Time frame: 3 months
Exercise Confidence Survey
Time frame: 3 months
Healthy Eating Self-Efficacy Survey
Time frame: 3 months
Eating Habits Confidence Survey
Time frame: 3 months
Acceptance of medication for CVD risk survey
Time frame: 3 months
Engagement with behavioral challenges
Time frame: 3 months
Change in weight
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Derived from this study: PubMed 36824050Maxwell TK, Charmant CO, Volkening LK, Laffel LM, Katz ML. A Randomized Pilot Trial Using Mobile Health and Financial Incentives to Motivate Heart-Healthy Behaviors in Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 May;17(3):855-856. doi: 10.1177/19322968231155151. Epub 2023 Feb 23. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
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. This study is not recruiting at the moment.
Lori Laffel principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart healthy intervention in people with Type1diabetes and Cardiovascular Risk Factor, run by Joslin Diabetes Center 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 4 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: finished, as of the sponsor's last update on 10 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Food Habits Checklist (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03531021, which also lists 1 linked publication.
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 10 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.