Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 14 - 19 |
| Updated: | 3/8/2019 |
| Start Date: | May 3, 2018 |
| End Date: | April 30, 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
One Joslin Place
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Michelle L Katz, MD
Phone: 617-732-2603
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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