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

April 28, 2021 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Barbara Davis Center for Childhood Diabetes
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
HbA1c will be measured to determine impact on glucose control
0, 3, 6, 12, 18, 24, 30 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of intervention delivery
Time Frame: 0-30 months
The study will evaluate cost to deliver intervention compared to usual care.
0-30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (ESTIMATE)

January 31, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2856 (UNC IRB)
  • 1UC4DK101132-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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