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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: FL3X: Flexible Lifestyle Empowering Change


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants randomized control will continue with usual clinical care. | |
| Experimental: Intervention<br>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<br>* 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.<br>* Other names: FL3X;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | 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 | Motivation related to diabetes care will be assessed | 0, 3, 6, 12, 18, 24, 30 months | 
| Problem solving skills | Assess use of problem solving skills relative to diabetes care | 0, 3, 6, 12, 18, 24, 30 months | 
| Hypoglycemia | Monitoring low blood sugar from continuous glucose monitoring | 0, 6, 18 mo | 
| Diabetes self-management behaviors | Assess use of diabetes self-management behaviors | 0, 3, 6, 12, 18, 24, 30 months | 
| Risk factors for diabetes complications | Assess variables related to diabetes complications | 0, 3, 6, 12, 18, 24, 30 months | 
| Health-related quality of life | Assess health-related quality of life | 0, 3, 6, 12, 18, 24, 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motivational interviewing, problem solving skills training, family communication, social support, adolescents