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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-01-31

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.

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Participants randomized control will continue with usual clinical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

FL3X: Flexible Lifestyle Empowering Change

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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FL3X

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