The Flexible Lifestyle Empowering Change (FLEX) intervention for self-management in adolescents with type 1 diabetes: Trial design and baseline characteristics

Abstract

The Flexible Lifestyle Empowering Change (FLEX) Intervention Study is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management for youth with type 1 diabetes mellitus (T1D). This paper details FLEX design, demographic characteristics of the sample, and outcome variables at baseline. Participants were randomized to either an intervention or control arm after their baseline standardized measurement visit. Baseline data for the primary (glycemic levels) and secondary outcome variables (e.g., motivation and problem-solving, health-related quality of life, risk factors associated with T1D complications) as well as the potential mediator variables (e.g., self-management behavior, family conflict and responsibility) suggest that the study sample was representative of the general population of adolescents with T1D and their parents. The FLEX adaptive intervention is an innovative application of a tailored treatment intervention designed to be readily adopted in real-world practice to meet each adolescent's individualized T1D self-management goals.

Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth

“…This randomized clinical trial tested an adaptive, 18-month intervention that included interventions to improve behavioral skills and problem solving for adolescents with type 1 diabetes, with respect to HbA 1c percentage of total hemoglobin (primary outcome), glycemic variability, cardiovascular disease risk factors, health-related QOL, and cost-effectiveness. 1 , 9 Eligible participants were adolescents aged 13 to 16 years with type 1 diabetes for 1 or more years with literacy in English, HbA 1c percentage of total hemoglobin of 8.0% to 13.0% (to convert to proportion of total hemoglobin, multiply by 0.01), at least 1 primary caregiver available to participate, and no other serious medical conditions or pregnancy. 9 Those randomized to the control arm received usual diabetes care.…”

“…Detailed considerations of the FLEX design and baseline participant characteristics have been described elsewhere. 9 As a randomized clinical trial, all reporting was standardized to the Consolidated Standards of Reporting Trials ( CONSORT ) reporting guideline. The present study was not prespecified in the FLEX trial protocol.…”

“…The full set of study measurements was obtained at baseline, 6 months, and 18 months postrandomization; a limited set of measurements was obtained at 3 months and 12 months postrandomization. 9 Standardized measurements, laboratory data, clinical measures, and questionnaires from the FLEX study are described in detail in eAppendix 1 in Supplement 2 . Standardized questionnaires were used to collect self-reported race/ethnicity, which was classified as non-Hispanic white, non-Hispanic black, Hispanic, and other, including Asian/Pacific Islander, Native American, or unknown.…”

Characterization of youth goal setting in the self‐management of type 1 diabetes and associations with HbA1c: The Flexible Lifestyle Empowering Change trial

“…Extended detail about intervention design, recruitment, delivery, measurements collected, and outcomes are described elsewhere. 25 In the sample used to conduct the present analysis, one participant who experienced a change in Hba1c of 9.3% (>4 SE from the mean) between first and last measurement visit was excluded. An additional four participants were excluded due to only having a baseline HbA1c measurement (and thus no coaching session data) which precluded the examination of associations between goal setting behavior and HbA1c that was of interest to this analysis.…”

“…Further rationale for and detail about the trial design is discussed in previous work summarizing the protocol. 25 Subsequent-coaching sessions followed the same format of the first four sessions and were scheduled three to four times over each 6 month period. Because FLEX was a SMART trial designed to be cost-effective and provide the least restrictive intervention for easier integration into existing medical care teams, a priori rules (based on change in HbA1c between standardized measurement sessions) governed the length of these subsequent sessions.…”