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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01286350

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Children's Hospital Medical Center, Cincinnati (Other), University of Colorado, Denver (Other), University of Washington (Other), Nemours Children's Clinic (Other), University of Pittsburgh (Other)

258

Enrollment

Locations

Arms

44.1

Duration (Months)

129

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Behavioral: FL3X: Flexible Lifestyle Empowering Change	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Participants randomized control will continue with usual clinical care.
Experimental: Intervention 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	Behavioral: FL3X: Flexible Lifestyle Empowering Change 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. Other Names: FL3X

Arm

Intervention/Treatment

No Intervention: Control

Participants randomized control will continue with usual clinical care.

Experimental: Intervention

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

Behavioral: FL3X: Flexible Lifestyle Empowering Change

Other Names:

FL3X

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c [0, 3, 6, 12, 18, 24, 30 months]
HbA1c will be measured to determine impact on glucose control

Secondary Outcome Measures

Motivation [0, 3, 6, 12, 18, 24, 30 months]
Motivation related to diabetes care will be assessed
Problem solving skills [0, 3, 6, 12, 18, 24, 30 months]
Assess use of problem solving skills relative to diabetes care
Hypoglycemia [0, 6, 18 mo]
Monitoring low blood sugar from continuous glucose monitoring
Diabetes self-management behaviors [0, 3, 6, 12, 18, 24, 30 months]
Assess use of diabetes self-management behaviors
Risk factors for diabetes complications [0, 3, 6, 12, 18, 24, 30 months]
Assess variables related to diabetes complications
Health-related quality of life [0, 3, 6, 12, 18, 24, 30 months]
Assess health-related quality of life

Other Outcome Measures

Cost of intervention delivery [0-30 months]
The study will evaluate cost to deliver intervention compared to usual care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Barbara Davis Center for Childhood Diabetes	Aurora	Colorado	United States	80045
2	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45206