Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study

Conditions
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Type1diabetes, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Heart healthy intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart healthy intervention<br>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. | Behavioral: Heart healthy intervention<br>* 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.<br>|
| No Intervention: Attention Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Food Habits Checklist | healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiposity | changes in zbmi | 3 months | 
| Blood pressure | Changes in blood pressure percentile | 3 months | 
| Changes in lipid levels | Changes in lipid levels from before study until study end | 3 months | 
| Activity level | Documentation of how active participants were during study | 3 months | 
| Exercise Confidence Survey | evaluation of self-efficacy for exercise | 3 months | 
| Healthy Eating Self-Efficacy Survey | healthy eating self-efficacy measure | 3 months | 
| Eating Habits Confidence Survey | evaluation of how confident participants are that they can eat in a healthy way | 3 months | 
| Acceptance of medication for CVD risk survey | brief questions to evaluate willingness to take medication if prescribed | 3 months | 
| Engagement with behavioral challenges | Proportion of intervention participants who completed challenges | 3 months | 
| Change in weight | change in weight in kg between enrollment and study completion | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, cardiovascular risk factor, teenager