- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286350
FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X) (FL3X)
FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Barbara Davis Center for Childhood Diabetes
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Ohio
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Cincinnati, Ohio, United States, 45206
- Cincinnati Children's Hospital Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Participants randomized control will continue with usual clinical care.
|
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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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
|
HbA1c will be measured to determine impact on glucose control
|
0, 3, 6, 12, 18, 24, 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
|
Motivation related to diabetes care will be assessed
|
0, 3, 6, 12, 18, 24, 30 months
|
Problem solving skills
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
|
Assess use of problem solving skills relative to diabetes care
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0, 3, 6, 12, 18, 24, 30 months
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Hypoglycemia
Time Frame: 0, 6, 18 mo
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Monitoring low blood sugar from continuous glucose monitoring
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0, 6, 18 mo
|
Diabetes self-management behaviors
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
|
Assess use of diabetes self-management behaviors
|
0, 3, 6, 12, 18, 24, 30 months
|
Risk factors for diabetes complications
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
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Assess variables related to diabetes complications
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0, 3, 6, 12, 18, 24, 30 months
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Health-related quality of life
Time Frame: 0, 3, 6, 12, 18, 24, 30 months
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Assess health-related quality of life
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0, 3, 6, 12, 18, 24, 30 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of intervention delivery
Time Frame: 0-30 months
|
The study will evaluate cost to deliver intervention compared to usual care.
|
0-30 months
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Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-2856 (UNC IRB)
- 1UC4DK101132-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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