Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

Joslin Diabetes Center45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type1diabetes Cardiovascular Risk Factor

Interventions

Heart healthy interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Adolescent Food Habits Checklist

healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.

Time frame: 3 months

Secondary Outcomes

Adiposity

changes in zbmi

Time frame: 3 months

Blood pressure

Changes in blood pressure percentile

Time frame: 3 months

Changes in lipid levels

Changes in lipid levels from before study until study end

Time frame: 3 months

Activity level

Documentation of how active participants were during study

Time frame: 3 months

Exercise Confidence Survey

evaluation of self-efficacy for exercise

Time frame: 3 months

Healthy Eating Self-Efficacy Survey

healthy eating self-efficacy measure

Time frame: 3 months

Eating Habits Confidence Survey

evaluation of how confident participants are that they can eat in a healthy way

Time frame: 3 months

Acceptance of medication for CVD risk survey

brief questions to evaluate willingness to take medication if prescribed

Data from ClinicalTrials.gov

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