FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)

University of North Carolina (UNC)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: FL3X: Flexible Lifestyle Empowering Change

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01286350

1UC4DK101132-01 (U.S. NIH Grant/Contract)

13-2856 (UNC IRB)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• pregnant (if female)
• diabetes type 2 or gestational
• Pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

Control

No Intervention group

Description:

Participants randomized control will continue with usual clinical care.

Intervention

Experimental group

Description:

Participants randomized to intervention will receive the "FL3X Flexible Lifestyle Empowering Change" intervention. Adolescents will be paired with a health coach to help learn strategies for improving diabetes control

Treatment:

Behavioral: FL3X: Flexible Lifestyle Empowering Change