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Type 1 DiabetesFL3XNCT01286350

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

A study testing FL3X: Flexible Lifestyle Empowering Change in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 16 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
FL3X: Flexible Lifestyle Empowering Change
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
2 sitesUnited States
Study dates
May 2014to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45206

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
FL3X: Flexible Lifestyle Empowering Change
Keywords
motivational interviewing, problem solving skills training, family communication, social support, adolescents
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FL3X: Flexible Lifestyle Empowering ChangeBehavioural

    Also called FL3X

    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.

Study groups in NCT01286350
Study groupRoleWhat they receive
ControlNo interventionParticipants randomized control will continue with usual clinical care.
InterventionExperimentalParticipants 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
Receives: Behavioral: FL3X: Flexible Lifestyle Empowering Change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c

    HbA1c will be measured to determine impact on glucose control

    Measured: 0, 3, 6, 12, 18, 24, 30 months

Secondary outcomes (6)

  1. Motivation

    Motivation related to diabetes care will be assessed

    Measured: 0, 3, 6, 12, 18, 24, 30 months

  2. Problem solving skills

    Assess use of problem solving skills relative to diabetes care

    Measured: 0, 3, 6, 12, 18, 24, 30 months

  3. Hypoglycemia

    Monitoring low blood sugar from continuous glucose monitoring

    Measured: 0, 6, 18 mo

  4. Diabetes self-management behaviors

    Assess use of diabetes self-management behaviors

    Measured: 0, 3, 6, 12, 18, 24, 30 months

  5. Risk factors for diabetes complications

    Assess variables related to diabetes complications

    Measured: 0, 3, 6, 12, 18, 24, 30 months

  6. Health-related quality of life

    Assess health-related quality of life

    Measured: 0, 3, 6, 12, 18, 24, 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2011 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01286350
Sponsor's protocol ID
13-2856 (UNC IRB)
Other IDs
1UC4DK101132-01
Acronym
FL3X
Status last verified
Feb 2019
First submitted
26 Jan 2011
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Cristello Sarteau A, Crandell J, Seid M, Kichler JC, Maahs DM, Wang J, Mayer-Davis E. Characterization of youth goal setting in the self-management of type 1 diabetes and associations with HbA1c: The Flexible Lifestyle Empowering Change trial. Pediatr Diabetes. 2020 Nov;21(7):1343-1352. doi: 10.1111/pedi.13099. Epub 2020 Sep 1.

    PubMed 32741045

  • Kahkoska AR, Lawson MT, Crandell J, Driscoll KA, Kichler JC, Seid M, Maahs DM, Kosorok MR, Mayer-Davis EJ. Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth: A Post Hoc Analysis of the FLEX Trial. JAMA Netw Open. 2019 May 3;2(5):e195137. doi: 10.1001/jamanetworkopen.2019.5137.

    PubMed 31150087

  • Mayer-Davis EJ, Maahs DM, Seid M, Crandell J, Bishop FK, Driscoll KA, Hunter CM, Kichler JC, Standiford D, Thomas JM; FLEX Study Group. Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial. Lancet Child Adolesc Health. 2018 Sep;2(9):635-646. doi: 10.1016/S2352-4642(18)30208-6. Epub 2018 Jul 30.

    PubMed 30119757

  • Zhong VW, Crandell JL, Shay CM, Gordon-Larsen P, Cole SR, Juhaeri J, Kahkoska AR, Maahs DM, Seid M, Forlenza GP, Mayer-Davis EJ. Dietary intake and risk of non-severe hypoglycemia in adolescents with type 1 diabetes. J Diabetes Complications. 2017 Aug;31(8):1340-1347. doi: 10.1016/j.jdiacomp.2017.04.017. Epub 2017 Apr 20.

    PubMed 28476567

  • Mayer-Davis EJ, Seid M, Crandell J, Dolan L, Lagarde WH, Letourneau L, Maahs DM, Marcovina S, Nachreiner J, Standiford D, Thomas J, Wysocki T. Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial. Diabet Med. 2015 Jun;32(6):829-33. doi: 10.1111/dme.12641. Epub 2014 Dec 30.

    PubMed 25424501

Questions about this trial

What is this clinical trial studying?

A study testing FL3X: Flexible Lifestyle Empowering Change in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (time frame: 0, 3, 6, 12, 18, 24, 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286350, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

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