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.
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).
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)
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.
Diabetes
Interventional
2014-05
2018-01
Type 1 Diabetes Mellitus
T1D Self-Management, Diabetes Mellitus, Type 1 (T1D), Glycated Haemoglobin A1c (HbA1c), Problem-Solving Skills Training (PSST), Flexible Empowering Lifestyle Change
Division of Diabetes, Endocrinology, and Metabolic Diseases
Document Name | Description | Document Type | File Format | Compliance | Download |
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Document Name | Description | Document Type | File Format |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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F14 Dataset | Contains data from Form 14 - Diabetes Family Responsibility Participant | 1462 | sas7bdat (320 KB); csv (117.57 KB) | |
F24-E Dataset | Contains data from Form 24-E | 1200 | sas7bdat (2.52 MB); csv (371.11 KB) | |
F29 Dataset | Contains data from Form 29 - CESD Participant | 1472 | sas7bdat (384 KB); csv (91.15 KB) | |
F15 Dataset | Contains data from Form 15 - hypoglycemia fear Parent | 735 | sas7bdat (256 KB); csv (69.37 KB) | |
F12 Dataset | Contains data from Form 12 - Diabetes Family Conflict Participant | 1464 | sas7bdat (384 KB); csv (106.98 KB) | |
HUI Dataset | Captures data on the results of the Health Utilities Index (HUI) | 752 | sas7bdat (192 KB); csv (44.01 KB) | |
OE Raw Dataset | Captures data on participant's outcome expectations for being involved in the FL3X study | 1443 | sas7bdat (704 KB); csv (236.77 KB) | |
F16 Dataset | Contains data from Form 16 - hypoglycemia fear Participant | 734 | sas7bdat (792 KB); csv (147.93 KB) | |
F11 Dataset | Contains data from Form 11 - Diabetes Family Conflict Parent | 1461 | sas7bdat (384 KB); csv (111.93 KB) | |
F17 Dataset | Contains data from Form 17 - PDQ Parent | 1458 | sas7bdat (384 KB); csv (88.44 KB) | |
F10 Dataset | Contains data from Form 10 - Diabetes Knowledge Participant | 736 | sas7bdat (320 KB); csv (70.77 KB) | |
F03 Dataset | Contains data from Form 3 - Intention and Motivation Participant | 1462 | sas7bdat (256 KB); csv (62.78 KB) | |
Age and Disease Duration Dataset | Captures data on the participant's age and duration of related disease (T1D) | 1494 | sas7bdat (128 KB); csv (73.67 KB) | |
Previous Day Physical Activity Recall Dataset | Captures data on the participant's physical activity recall from the prior day | 341 | sas7bdat (128 KB); csv (13.69 KB) | |
F26-Ins Dataset | Contains data from Form 26 - previous day's insulin use | 741 | sas7bdat (128 KB); csv (32.06 KB) | |
F18 Dataset | Contains data from Form 18 - PDQ Participant | 1461 | sas7bdat (384 KB); csv (88.53 KB) | |
Social Problem-Solving inventory Dataset | Captures data on Social Problem-Solving Inventory (SPSI) Questionnaire results | 1490 | sas7bdat (256 KB); csv (78.77 KB) | |
Ibs Child Raw Dataset | Captures data on variables related to the Child's weight and other health status assessments | 734 | sas7bdat (760 KB); csv (160.82 KB) | |
F19 Dataset | Contains data from Form 19 - Health Behaviors Participant | 733 | sas7bdat (880 KB); csv (162.99 KB) | |
F05 Dataset | Contains data from Form 5 | 986 | sas7bdat (128 KB); csv (55.02 KB) | |
Ibs Parent Raw Dataset | Captures data on variables related to the Parent's weight and other health status assessments | 735 | sas7bdat (320 KB); csv (82.27 KB) | |
BMI Dataset | Captures data on the participant's Body Mass Index (BMI) Z-score and weight status | 1248 | sas7bdat (128 KB); csv (44.97 KB) | |
F21 Dataset | Contains data from Form 21 - Diabetes Eating Problem Survey Participant | 735 | sas7bdat (192 KB); csv (37.43 KB) | |
F38 Dataset | Contains data from Form 38 - Outcome Expectations Participant | 1453 | sas7bdat (448 KB); csv (133.74 KB) | |
F20 Dataset | Contains data from Form 20 - Household Food Security Parent | 492 | sas7bdat (128 KB); csv (19.22 KB) | |
F09 Dataset | Contains data from Form 9 - DSMP Participant | 1464 | sas7bdat (448 KB); csv (100.72 KB) | |
Lab Dataset | Captures data on all laboratory results and information associated with the FL3X study | 1472 | sas7bdat (256 KB); csv (72.21 KB) | |
F06/07 Dataset | Contains data from Form 6 - PedsQL Parent and Form 7 - PedsQL Participant | 1470 | sas7bdat (704 KB); csv (203.12 KB) | |
F08 Dataset | Contains data from Form 8 - DSMP Parent | 1460 | sas7bdat (448 KB); csv (100.18 KB) | |
24-hour Diet Recall Dataset | Captures data on the participant's diet from the past 24 hours | 392 | sas7bdat (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 day | 1451 | sas7bdat (384 KB); csv (113.42 KB) | |
F39 Dataset | Contains data from Form 39 - Self efficacy Participant | 1456 | sas7bdat (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 levels | 685 | sas7bdat (960 KB); csv (1.31 MB) | |
F26 Dataset | Contains data from Form 26 | 741 | sas7bdat (1012 KB); csv (271.69 KB) | |
Base Variables Dataset | Dataset that includes variables that were only measured at baseline - participant information and demographics | 258 | sas7bdat (128 KB); csv (10.97 KB) | |
F30 Dataset | Contains data from Form 30 - Tanner Male Participant | 357 | sas7bdat (128 KB); csv (6.55 KB) | |
F28 Dataset | Contains data from Form 28 - Health History Participant | 735 | sas7bdat (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 day | 1448 | sas7bdat (384 KB); csv (113.26 KB) | |
Group Assignment Dataset | Captures data on initial group assignment and re-assignment of group at 18 months | 258 | sas7bdat (128 KB); csv (7.26 KB) | |
F31 Dataset | Contains data from Form 31 - Tanner Female Participant | 353 | sas7bdat (128 KB); csv (7.18 KB) | |
F13 Dataset | Contains data from Form 13 - Diabetes Family Responsibility Parent | 1462 | sas7bdat (320 KB); csv (117.63 KB) |