Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

NCT03531021 | Completed

• 1 other identifier: 2017-34
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes; Cardiovascular Risk Factor

Keywords

type 1 diabetes; cardiovascular risk factor; teenager

Outcome Measures

Primary Outcomes (1)

• Adolescent Food Habits Checklist

  healthy eating questionnaire, 23 question true/false survey, score range from 0-23, higher scores indicate healthier habits, no subscales.

  3 months

Secondary Outcomes (10)

• Adiposity

  3 months

• Blood pressure

  3 months

• Changes in lipid levels

  3 months

• Activity level

  3 months

• Exercise Confidence Survey

  3 months

Study Arms (2)

Heart healthy intervention

EXPERIMENTAL

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.

Behavioral: Heart healthy intervention

Attention Control

NO INTERVENTION

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.

Interventions

Heart healthy intervention 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.

Heart healthy intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 36824050 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lori Laffel

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 26, 2018
• First Posted: May 21, 2018
• Study Start: May 3, 2018
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)