FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT01286350
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
The purpose of this study is to see if a behavioral intervention for adolescents with type 1 diabetes will improve adherence to T1D self-management activities and improve diabetes outcomes. We expect the intervention to improve diabetes outcomes when compared to usual care.
- Detailed Description
The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.
All FL3X intervention participants will receive "FL3X-Basic", which is the initial 3-month intervention that includes 4 sessions (40-60 min), supplemented with short additional contacts (via text, email, or web-based communication) as needed. Thereafter, applying principles of adaptive interventions, based on a decision rule using A1c values measured at defined intervals, participants are iteratively assigned to "FL3X-Check-in" or "FL3X-Regular", both of which continue with MI and PSST for the underlying counseling strategy. In FL3X-Check-in, participants who are doing well ("responders") will receive minimal ongoing support to reinforce successful strategies through brief monthly "touch-base" contacts. In FL3X-Regular, those who are "Regular-responders" will have a minimum of 3-4 in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief contacts as needed (e.g., text, voice, or internet). FL3X participants randomized to the control group will receive usual care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- type 1 diabetes with duration at least 12 months
- between ages 12-16 years at registration
- poor glycemic control (A1c 8.0-13.0%)
- parent/guardian willing to also participate
- not planning on moving in the following 18 months
- pregnant (if female)
- diabetes type 2 or gestational
- Pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemoglobin A1c 0, 3, 6, 12, 18, 24, 30 months HbA1c will be measured to determine impact on glucose control
- Secondary Outcome Measures
Name Time Method Problem solving skills 0, 3, 6, 12, 18, 24, 30 months Assess use of problem solving skills relative to diabetes care
Diabetes self-management behaviors 0, 3, 6, 12, 18, 24, 30 months Assess use of diabetes self-management behaviors
Motivation 0, 3, 6, 12, 18, 24, 30 months Motivation related to diabetes care will be assessed
Risk factors for diabetes complications 0, 3, 6, 12, 18, 24, 30 months Assess variables related to diabetes complications
Hypoglycemia 0, 6, 18 mo Monitoring low blood sugar from continuous glucose monitoring
Health-related quality of life 0, 3, 6, 12, 18, 24, 30 months Assess health-related quality of life
Trial Locations
- Locations (2)
University of Colorado Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States