NCT01286350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
3.2 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 29, 2021

Status Verified

February 1, 2019

Enrollment Period

3.6 years

First QC Date

January 26, 2011

Last Update Submit

April 28, 2021

Conditions

Type 1 Diabetes

Keywords

motivational interviewingproblem solving skills trainingfamily communicationsocial supportadolescents

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    HbA1c will be measured to determine impact on glucose control

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Cost of intervention delivery

    0-30 months

Study Arms (2)

Control

NO INTERVENTION

Participants randomized control will continue with usual clinical care.

Intervention

EXPERIMENTAL

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

Interventions

FL3X: Flexible Lifestyle Empowering ChangeBEHAVIORAL

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.

Also known as: FL3X
Intervention

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Related Publications (5)

  • 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.

    PMID: 32741045DERIVED

  • 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.

    PMID: 31150087DERIVED

  • 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.

    PMID: 30119757DERIVED

  • 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.

    PMID: 28476567DERIVED

  • 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.

    PMID: 25424501DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Elizabeth Mayer-Davis, PhD

    UNC-CH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 31, 2011

Study Start

May 1, 2014

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 29, 2021

Record last verified: 2019-02

Locations

US(2)