medwireNews: The Flexible Lifestyles Empowering Change (FLEX) intervention has failed to improve glycated hemoglobin (HbA1c) levels in a randomized trial involving adolescents with type 1 diabetes, despite improving some psychosocial outcomes.
As described in The Lancet Child & Adolescent Health, the FLEX intervention used motivational interviewing to generate a desire for change, after which the coach moved on to problem-solving skills. The coaches had access to a “flexible array of tools,” including elements of behavioral family systems therapy and educational materials to support type 1 diabetes self-management, to help them address patients’ specific barriers at particular times.
In a linked commentary, Tonja Nansel (Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA) praises the study, saying that the approach is well supported by previous research, particularly in the enrolled age range (13–16 years), and was “delivered with excellent fidelity” and high study participant completion and retention.
“As such, the null findings of the primary outcome of glycaemic control are unexpected and suggest that further research is needed to establish the most efficacious application of behavioural approaches to improve disease management,” she writes.
The 130 patients assigned to the FLEX group received the core intervention during four sessions delivered over 12 weeks, with intervention periods thereafter ending at 6, 12, and 18 months. The change in their HbA1c during these periods determined subsequent intervention intensity; around 80% of participants had coaching sessions for the whole 18 months, whereas those who had reached the target of 58 mmol/mol (7.5%) or had improved by a prespecified amount switched to monthly 10–15-minute phone calls.
At baseline, the patients had an average HbA1c of 83 mmol/mol (9.7%) and this did not appreciably change during the intervention, being 81 mmol/mol (9.6%) after 3 months and 84 mmol/mol (9.8%) after 18 months. In the control group of 128 patients who received usual care, HbA1c rose from 80 to 82 mmol/mol (9.5 to 9.7%).
This was despite Elizabeth Mayer-Davis (Gillings School of Global Public Health, Chapel Hill, North Carolina, USA) and co-researchers finding significant improvements in motivation, problem-solving, and diabetes self-management among adolescents assigned to the FLEX intervention.
In her commentary, Nansel observes that the “clinical meaningfulness of these findings is uncertain” in the absence of HbA1c improvement, and suggests that participation in FLEX might have prompted the patients “to report behaviour consistent with the intervention targets.”
However, she highlights the significant and clinically meaningful improvements in quality of life, parent–child conflict, and fear of hypoglycemia that also occurred in the FLEX group.
“The adverse psychosocial toll of managing type 1 diabetes is well documented; as such, the application of healthcare approaches that promote psychosocial health is of crucial importance independent of any effect on glycaemic control,” she concludes.
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