Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes
Condition: Type1diabetes; Cardiovascular Risk Factor
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Heart healthy intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: type 1 diabetes; cardiovascular risk factor; teenager