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Completed

NCT Number: NCT01286350

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

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.

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Key information

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FL3X: Flexible Lifestyle Empowering Change

Behavioral

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

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    HbA1c will be measured to determine impact on glucose control

Secondary outcomes

  1. Motivation

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    Motivation related to diabetes care will be assessed

  2. Problem solving skills

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    Assess use of problem solving skills relative to diabetes care

  3. Hypoglycemia

    Time frame: 0, 6, 18 mo

    Monitoring low blood sugar from continuous glucose monitoring

  4. Diabetes self-management behaviors

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    Assess use of diabetes self-management behaviors

  5. Risk factors for diabetes complications

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    Assess variables related to diabetes complications

  6. Health-related quality of life

    Time frame: 0, 3, 6, 12, 18, 24, 30 months

    Assess health-related quality of life

Other outcomes

  1. Cost of intervention delivery

    Time frame: 0-30 months

    The study will evaluate cost to deliver intervention compared to usual care.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FL3X

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 31, 2011
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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