Contemporary Clinical Trials Communications (Jun 2023)
A primary care delivered, technology supported lifestyle program for Type 2 Diabetes Management: An evaluation of changes in metabolic health, feasibility, and acceptability – A pilot interventional study protocol
Abstract
Background: Type 2 Diabetes (T2D) is associated with significant health complications and socioeconomic costs. Previous research conducted through an outpatient research facility demonstrated use of a low carbohydrate (LC) diet and exercise plan delivered in the format of an education book combined with use of real-time continuous glucose monitoring (RT-CGM) is an effective self-management intervention to improve weight and blood glucose management in patients with T2D. Primary health care remains the central access point for patient management of T2D, but General Practitioners (GPs) lack access to effective evidenced-based, self-management programs that can be prescribed to improve patient outcomes. Methods: A single-arm, within-participant pilot intervention study will be conducted to evaluate the changes in metabolic health, acceptability and feasibility of a prescriptive LC diet and lifestyle program combined with RT-CGM (LC-RTC) delivered via GP practices. Forty adults with T2D will be recruited from GP practices and prescribed the LC-RTC intervention for 12 weeks. Outcomes will be assessed at baseline and 12-weeks post intervention. Changes in metabolic health will be assessed by changes in glycosylated hemoglobin (primary outcome), body weight, blood pressure, blood lipids, and medication usage. Post-intervention, participants will complete questionnaires and participate in focus groups to explore their experience of the LC-RTC program including acceptance, perceived benefits/barriers, limitations, financial feasibility, intervention drop-out rates, participant and GP engagement with the program (clinic attendance and contacts made to clinic for program support) and RT-CGM use and wear time acceptance. GPs and clinical staff involved will participate focus groups to evaluate the perceived value and feasibility of the LC-RTC program. Discussion: This trial will provide a powered evaluation of the changes in metabolic health, acceptability, and feasibility of the LC-RTC program for patients with T2D delivered via GP practices. Trial registration: ANZCTR: 12622000635763 (Website Link to full registration: ANZCTR - Registration). Registered 29th April 2022. Overall trial status: Commenced; Recruitment Status: Commenced 1st May 2022, with 40 participants recruited as of 2nd May 2023 using a rolling recruitment approach.
