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
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Behavioral: FL3X: Flexible Lifestyle Empowering Change

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: May 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: FL3X

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.

  Eligibility

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286350

Contacts
Contact: Joan M Thomas, MS, RD 919-843-8423 joan_thomas@unc.edu

Locations
United States, Colorado
University of Colorado Barbara Davis Center for Childhood Diabetes Recruiting
Aurora, Colorado, United States, 80045
Contact: Franziska Bishop    303-724-8478    FL3X@ucdenver.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45206
Contact: Debbie Standiford    513-803-9200    Debbie.Standiford@cchmc.org   
Contact: Emily Smith         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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
Investigators
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC-CH
  More Information

Additional Information:
No publications provided

Responsible Party: Elizabeth Mayer-Davis, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01286350     History of Changes
Other Study ID Numbers: 13-2856 (UNC IRB), 1UC4DK101132-01
Study First Received: January 26, 2011
Last Updated: October 17, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Data and Safety Monitoring Board

Keywords provided by University of North Carolina, Chapel Hill:
motivational interviewing
problem solving skills training
family communication
social support
adolescents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014