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Citation
Mayer, Elizabeth (2021). FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/235v-4k70
Data Availability Statement
Data from FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X) [(Version 1) https://doi.org/10.58020/235v-4k70] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The FL3X study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the FL3X (https://doi.org/10.58020/235v-4k70) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the FL3X study and does not necessarily reflect the opinions or views of the FL3X study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Feb 23, 2021)
Resource Availability
  • Data Available for Request
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General Description

The FL3X Adaptive Intervention was 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 received "FL3X-Basic", which was 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 received usual care.

Outcome Measure

The primary outcome was measurement of glycated haemoglobin A1c (HbA1c) at 18 months. Secondary outcomes included motivation and intention, problem solving skills, self-management behaviors, symptoms of depression, health related quality of life, fear of hypoglycemia, diabetes family conflict, risk factors for T1D complications (BMI, blood pressure, and plasma lipids), and hypoglycemia derived from continuous glucose monitoring (percent time below 3·0 and 3·9 mmol/l [54 and 70 mg/dl]). Intention-to-treat analyses used mixed effects models, with fixed effects including site, timepoint, intervention group, intervention by timepoint, and baseline level of primary (HbA1c) or secondary outcomes (α=0·05).

Eligibility 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)

Outcome

The FLEX intervention did not significantly change HbA1c among these adolescents with elevated HbA1c, but did positively affect several psychosocial outcomes over 18 months. Further analyses will provide information regarding drivers of positive response to the intervention and will point to future directions for improvement in the approach.

Research Area

Diabetes

Study Type

Interventional

Study Start Date

2014-05

Study End Date

2018-01

Condition

Type 1 Diabetes Mellitus

Keywords

T1D Self-Management, Diabetes Mellitus, Type 1 (T1D), Glycated Haemoglobin A1c (HbA1c), Problem-Solving Skills Training (PSST), Flexible Empowering Lifestyle Change

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases

258
Participants

Target Population
Children

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Non-Public Documents (1)
Non-Public Documents Table
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Datasets (41)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
F14 Dataset
Contains data from Form 14 - Diabetes Family Responsibility Participant1462sas7bdat (320 KB); csv (117.57 KB)
F24-E Dataset
Contains data from Form 24-E1200sas7bdat (2.52 MB); csv (371.11 KB)
F29 Dataset
Contains data from Form 29 - CESD Participant1472sas7bdat (384 KB); csv (91.15 KB)
F15 Dataset
Contains data from Form 15 - hypoglycemia fear Parent735sas7bdat (256 KB); csv (69.37 KB)
F12 Dataset
Contains data from Form 12 - Diabetes Family Conflict Participant1464sas7bdat (384 KB); csv (106.98 KB)
HUI Dataset
Captures data on the results of the Health Utilities Index (HUI)752sas7bdat (192 KB); csv (44.01 KB)
OE Raw Dataset
Captures data on participant's outcome expectations for being involved in the FL3X study1443sas7bdat (704 KB); csv (236.77 KB)
F16 Dataset
Contains data from Form 16 - hypoglycemia fear Participant734sas7bdat (792 KB); csv (147.93 KB)
F11 Dataset
Contains data from Form 11 - Diabetes Family Conflict Parent1461sas7bdat (384 KB); csv (111.93 KB)
F17 Dataset
Contains data from Form 17 - PDQ Parent1458sas7bdat (384 KB); csv (88.44 KB)
F10 Dataset
Contains data from Form 10 - Diabetes Knowledge Participant736sas7bdat (320 KB); csv (70.77 KB)
F03 Dataset
Contains data from Form 3 - Intention and Motivation Participant1462sas7bdat (256 KB); csv (62.78 KB)
Age and Disease Duration Dataset
Captures data on the participant's age and duration of related disease (T1D)1494sas7bdat (128 KB); csv (73.67 KB)
Previous Day Physical Activity Recall Dataset
Captures data on the participant's physical activity recall from the prior day341sas7bdat (128 KB); csv (13.69 KB)
F26-Ins Dataset
Contains data from Form 26 - previous day's insulin use741sas7bdat (128 KB); csv (32.06 KB)
F18 Dataset
Contains data from Form 18 - PDQ Participant1461sas7bdat (384 KB); csv (88.53 KB)
Social Problem-Solving inventory Dataset
Captures data on Social Problem-Solving Inventory (SPSI) Questionnaire results1490sas7bdat (256 KB); csv (78.77 KB)
Ibs Child Raw Dataset
Captures data on variables related to the Child's weight and other health status assessments734sas7bdat (760 KB); csv (160.82 KB)
F19 Dataset
Contains data from Form 19 - Health Behaviors Participant733sas7bdat (880 KB); csv (162.99 KB)
F05 Dataset
Contains data from Form 5986sas7bdat (128 KB); csv (55.02 KB)
Ibs Parent Raw Dataset
Captures data on variables related to the Parent's weight and other health status assessments735sas7bdat (320 KB); csv (82.27 KB)
BMI Dataset
Captures data on the participant's Body Mass Index (BMI) Z-score and weight status1248sas7bdat (128 KB); csv (44.97 KB)
F21 Dataset
Contains data from Form 21 - Diabetes Eating Problem Survey Participant735sas7bdat (192 KB); csv (37.43 KB)
F38 Dataset
Contains data from Form 38 - Outcome Expectations Participant1453sas7bdat (448 KB); csv (133.74 KB)
F20 Dataset
Contains data from Form 20 - Household Food Security Parent492sas7bdat (128 KB); csv (19.22 KB)
F09 Dataset
Contains data from Form 9 - DSMP Participant1464sas7bdat (448 KB); csv (100.72 KB)
Lab Dataset
Captures data on all laboratory results and information associated with the FL3X study1472sas7bdat (256 KB); csv (72.21 KB)
F06/07 Dataset
Contains data from Form 6 - PedsQL Parent and Form 7 - PedsQL Participant1470sas7bdat (704 KB); csv (203.12 KB)
F08 Dataset
Contains data from Form 8 - DSMP Parent1460sas7bdat (448 KB); csv (100.18 KB)
24-hour Diet Recall Dataset
Captures data on the participant's diet from the past 24 hours392sas7bdat (1.59 MB); csv (561.58 KB)
Previous Dat Physical Activity Recall Child Raw Dataset
Captures raw data on the child's physical activity recall from the prior day1451sas7bdat (384 KB); csv (113.42 KB)
F39 Dataset
Contains data from Form 39 - Self efficacy Participant1456sas7bdat (256 KB); csv (62.38 KB)
Continuous Glucose Monitoring Dataset
Captures data on the results information related to continuous monitoring of the participant's glucose levels685sas7bdat (960 KB); csv (1.31 MB)
F26 Dataset
Contains data from Form 26741sas7bdat (1012 KB); csv (271.69 KB)
Base Variables Dataset
Dataset that includes variables that were only measured at baseline - participant information and demographics258sas7bdat (128 KB); csv (10.97 KB)
F30 Dataset
Contains data from Form 30 - Tanner Male Participant357sas7bdat (128 KB); csv (6.55 KB)
F28 Dataset
Contains data from Form 28 - Health History Participant735sas7bdat (800 KB); csv (155.52 KB)
Previous Dat Physical Activity Recall Parent Raw Dataset
Captures raw data on the parent's physical activity recall from the prior day1448sas7bdat (384 KB); csv (113.26 KB)
Group Assignment Dataset
Captures data on initial group assignment and re-assignment of group at 18 months258sas7bdat (128 KB); csv (7.26 KB)
F31 Dataset
Contains data from Form 31 - Tanner Female Participant353sas7bdat (128 KB); csv (7.18 KB)
F13 Dataset
Contains data from Form 13 - Diabetes Family Responsibility Parent1462sas7bdat (320 KB); csv (117.63 KB)