Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

NCT ID: NCT03531021

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2019-02-08

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.

Conditions

Type1diabetes; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Heart healthy intervention

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. Participants will be placed on teams and encouraged to complete behavioral challenges to earn points towards a cash reward.

Group Type: EXPERIMENTAL

Heart healthy intervention

Intervention Type: BEHAVIORAL

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.

Attention Control

There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the RAs for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Laffel

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

References

Maxwell TK, Charmant CO, Volkening LK, Laffel LM, Katz ML. A Randomized Pilot Trial Using Mobile Health and Financial Incentives to Motivate Heart-Healthy Behaviors in Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 May;17(3):855-856. doi: 10.1177/19322968231155151. Epub 2023 Feb 23. No abstract available.

Reference Type: DERIVED

PMID: 36824050 (View on PubMed)

Other Identifiers

2017-34

Identifier Type: -

Identifier Source: org_study_id