Clinical trial NCT03531021: Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes
Official title: Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Cardiovascular Risk Factor
Keywords: type 1 diabetes
cardiovascular risk factor
teenager
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adolescent Food Habits Checklist
timeFrame: 3 months
Secondary outcomes:
measure: Adiposity
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Changes in lipid levels
timeFrame: 3 months
measure: Activity level
timeFrame: 3 months
measure: Exercise Confidence Survey
timeFrame: 3 months
measure: Healthy Eating Self-Efficacy Survey
timeFrame: 3 months
measure: Eating Habits Confidence Survey
timeFrame: 3 months
measure: Acceptance of medication for CVD risk survey
timeFrame: 3 months
measure: Engagement with behavioral challenges
timeFrame: 3 months
measure: Change in weight
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori Laffel
role: PRINCIPAL_INVESTIGATOR
References: