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Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.
This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.
This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).
Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.
by Claire A. MacGeorge, Matthew Henry, Hannah A. Ford, Lacy Malloch, Emily Fratesi, Shannon Cabaniss, Jaime Baldner, Melody Greer, Kristin Gaffney, Milan Bimali, Preetha Abraham, Linda Y. Fu, P. Songthip Ounpraseuth, Christine B. Turley
BackgroundAttention-deficit/hyperactivity Disorder (ADHD) is the most common neurobehavioral condition of childhood and can be controlled with stimulant medication. Evidence-based guidelines endorse use of standardized ADHD symptom reports to facilitate medication titration to therapeutic dosage. Children living in under-resourced areas experience barriers to receiving this recommended evidence-based care. The Remote ADHD Monitoring Program (RAMP) uses a text-based platform to relay symptom reports from caregivers and teachers to healthcare providers. This pilot study is a feasibility study examining intervention uptake. It compares the submission of structured symptom reports in those children enrolled in RAMP compared to usual care as well as utilization of the RAMP platform by providers.
MethodsThis paper describes the protocol to evaluate the feasibility of deploying RAMP in practices serving rural or underserved children. We will recruit 36 dyads from 4 practices in 2 separate states. Each dyad will include a caregiver and their child aged 5–11 years with a diagnosis of ADHD who is starting or reinitiating stimulants. Dyads will be randomized 1:1 to receive the RAMP intervention or usual care with attention controls. Our primary outcome is number of symptom reports (paper assessments in control arm and RAMP reports in intervention arm) per participant that are completed by caregivers and teachers and returned to providers. Our secondary outcome is proportion of submitted RAMP reports that are reviewed by providers.
DiscussionAs telehealth use increases, it is critical that we improve access to high quality care for children with chronic conditions. Leveraging technology may be a meaningful approach to improve efficiency in optimizing medication management. This pilot study tests a text-based platform designed to improve communication between the caregivers and teachers of children with ADHD and health care providers. If successful, a future trial will examine the effectiveness of the RAMP intervention on improvement in symptoms.
Trial registrationClinicalTrials.gov NCT06743425.
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