Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Heart healthy intervention

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart healthy intervention; 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; 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.
No Intervention: Attention Control; 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?

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

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Investigators: Principal Investigator: Lori Laffel, Joslin Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: type 1 diabetes; cardiovascular risk factor; teenager
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2017-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No