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

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

Sponsors

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
University of Colorado Denver School of Medicine Barbara Davis Center
University of Washington
Nemours Children's Clinic
University of Pittsburgh

Source 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.

Overall Status Completed
Start Date May 2014
Completion Date January 2018
Primary Completion Date December 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin A1c 0, 3, 6, 12, 18, 24, 30 months
Secondary Outcome
Measure Time Frame
Motivation 0, 3, 6, 12, 18, 24, 30 months
Problem solving skills 0, 3, 6, 12, 18, 24, 30 months
Hypoglycemia 0, 6, 18 mo
Diabetes self-management behaviors 0, 3, 6, 12, 18, 24, 30 months
Risk factors for diabetes complications 0, 3, 6, 12, 18, 24, 30 months
Health-related quality of life 0, 3, 6, 12, 18, 24, 30 months
Enrollment 258
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: FL3X: Flexible Lifestyle Empowering Change

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.

Arm Group Label: Intervention

Other Name: FL3X

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 13 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Elizabeth Mayer-Davis, PhD Principal Investigator UNC-CH
Location
Facility:
University of Colorado Barbara Davis Center for Childhood Diabetes | Aurora, Colorado, 80045, United States
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45206, United States
Location Countries

United States

Verification Date

February 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: No Intervention

Description: Participants randomized control will continue with usual clinical care.

Label: Intervention

Type: Experimental

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

Acronym FL3X
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov