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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
University of Colorado Denver School of Medicine Barbara Davis Center
University of Washington
Nemours Children's Clinic
University of Pittsburgh
Information provided by (Responsible Party):
Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01286350
First received: January 26, 2011
Last updated: October 17, 2014
Last verified: October 2014

January 26, 2011
October 17, 2014
May 2014
August 2017   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 0, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
HbA1c will be measured to determine impact on glucose control
Change from Baseline in HbA1c at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01286350 on ClinicalTrials.gov Archive Site
  • Motivation [ Time Frame: 0, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
    Motivation related to diabetes care will be assessed
  • Problem solving skills [ Time Frame: 0, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
    Assess use of problem solving skills relative to diabetes care
  • Hypoglycemia [ Time Frame: 0, 6, 18 mo ] [ Designated as safety issue: No ]
    Monitoring low blood sugar from continuous glucose monitoring
  • Diabetes self-management behaviors [ Time Frame: 0, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
    Assess use of diabetes self-management behaviors
  • Risk factors for diabetes complications [ Time Frame: 0, 3, 6, 12, 18 ] [ Designated as safety issue: No ]
    Assess variables related to diabetes complications
  • Health-related quality of life [ Time Frame: 0, 3, 6, 12, 18 ] [ Designated as safety issue: No ]
    Assess health-related quality of life
Change from Baseline in Quality of Life measures at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Quality of Life will be assessed via self report questionnaire data.
Cost of intervention delivery [ Time Frame: 0-18 months ] [ Designated as safety issue: No ]
The study will evaluate cost to deliver intervention compared to usual care.
Not Provided
 
FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
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 Name: FL3X
  • 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
    Intervention: Behavioral: FL3X: Flexible Lifestyle Empowering Change
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2017
August 2017   (final data collection date for primary outcome measure)

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)
Both
13 Years to 16 Years
No
Contact: Joan M Thomas, MS, RD 919-843-8423 joan_thomas@unc.edu
United States
 
NCT01286350
13-2856 (UNC IRB), 1UC4DK101132-01
Yes
Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Children's Hospital Medical Center, Cincinnati
  • University of Colorado Denver School of Medicine Barbara Davis Center
  • University of Washington
  • Nemours Children's Clinic
  • University of Pittsburgh
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC-CH
University of North Carolina, Chapel Hill
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP