Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531021
• Other study ID #: 2017-34
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: February 8, 2019

Study information

• Verified date: August 2021
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

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