Clinical trial NCT01286350: FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)
Official title: FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: motivational interviewing
problem solving skills training
family communication
social support
adolescents
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's Hospital Medical Center, Cincinnati
name: University of Colorado, Denver
name: University of Washington
name: Nemours Children's Clinic
name: University of Pittsburgh
First posted: 2011-01-31
Enrollment: 258
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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)

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
Secondary outcomes:
measure: Motivation
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
measure: Problem solving skills
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
measure: Hypoglycemia
timeFrame: 0, 6, 18 mo
measure: Diabetes self-management behaviors
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
measure: Risk factors for diabetes complications
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
measure: Health-related quality of life
timeFrame: 0, 3, 6, 12, 18, 24, 30 months
Other outcomes:
measure: Cost of intervention delivery
timeFrame: 0-30 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: UNC-CH
name: Elizabeth Mayer-Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cristello Sarteau A, Crandell J, Seid M, Kichler JC, Maahs DM, Wang J, Mayer-Davis E. Characterization of youth goal setting in the self-management of type 1 diabetes and associations with HbA1c: The Flexible Lifestyle Empowering Change trial. Pediatr Diabetes. 2020 Nov;21(7):1343-1352. doi: 10.1111/pedi.13099. Epub 2020 Sep 1.
citation: Kahkoska AR, Lawson MT, Crandell J, Driscoll KA, Kichler JC, Seid M, Maahs DM, Kosorok MR, Mayer-Davis EJ. Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth: A Post Hoc Analysis of the FLEX Trial. JAMA Netw Open. 2019 May 3;2(5):e195137. doi: 10.1001/jamanetworkopen.2019.5137.
citation: Mayer-Davis EJ, Maahs DM, Seid M, Crandell J, Bishop FK, Driscoll KA, Hunter CM, Kichler JC, Standiford D, Thomas JM; FLEX Study Group. Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial. Lancet Child Adolesc Health. 2018 Sep;2(9):635-646. doi: 10.1016/S2352-4642(18)30208-6. Epub 2018 Jul 30.
citation: Zhong VW, Crandell JL, Shay CM, Gordon-Larsen P, Cole SR, Juhaeri J, Kahkoska AR, Maahs DM, Seid M, Forlenza GP, Mayer-Davis EJ. Dietary intake and risk of non-severe hypoglycemia in adolescents with type 1 diabetes. J Diabetes Complications. 2017 Aug;31(8):1340-1347. doi: 10.1016/j.jdiacomp.2017.04.017. Epub 2017 Apr 20.
citation: Mayer-Davis EJ, Seid M, Crandell J, Dolan L, Lagarde WH, Letourneau L, Maahs DM, Marcovina S, Nachreiner J, Standiford D, Thomas J, Wysocki T. Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial. Diabet Med. 2015 Jun;32(6):829-33. doi: 10.1111/dme.12641. Epub 2014 Dec 30.