An interventional study of FL3X: Flexible Lifestyle Empowering Change in Type 1 Diabetes, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to participants aged 13 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 258 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized control will continue with usual clinical care.
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.
Also known as: FL3X
Hemoglobin A1c
HbA1c will be measured to determine impact on glucose control
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Motivation
Motivation related to diabetes care will be assessed
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Problem solving skills
Assess use of problem solving skills relative to diabetes care
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Hypoglycemia
Monitoring low blood sugar from continuous glucose monitoring
Time frame: 0, 6, 18 mo
Diabetes self-management behaviors
Assess use of diabetes self-management behaviors
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Risk factors for diabetes complications
Assess variables related to diabetes complications
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Health-related quality of life
Assess health-related quality of life
Time frame: 0, 3, 6, 12, 18, 24, 30 months
Cost of intervention delivery
The study will evaluate cost to deliver intervention compared to usual care.
Time frame: 0-30 months
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill