NCT03531021

Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 14 Years – 19 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-03
• Primary completion: 2019-02-08
• Completion: 2019-02-08
• First posted: 2018-05-21
• Last updated: 2021-08-10

Locations

1 site across 1 country: United States