Produce Prescription: Improving diet and health outcomes of pregnant women with, or at increased risk of, gestational diabetes and with food insecurity in Australia

Background

Gestational diabetes mellitus (GDM) is a condition characterised by higher-than-normal blood glucose concentrations during pregnancy with immediate and long-term health consequences. Gestational diabetes affects more than 1 in 6 Australian pregnant women. Healthy eating advice is the first line treatment for women with, or at high-risk of developing GDM. But for pregnant women with food insecurity (i.e. barriers to affording or accessing nutritious food) following the dietary advice given can be challenging.

‘Food is Medicine’ programs integrate nutrition interventions into healthcare to improve the diet of clinical populations. ‘Produce Prescription’ is one approach, where free or subsidised healthy foods are prescribed to people with a clinical need and who experience food insecurity as part of their healthcare. Our study is the global first randomised controlled trial of ‘Produce Prescription’ versus usual care in pregnancy.

Aim

Our study aims to test whether a ‘Produce Prescription’ intervention can reduce gestational weight gain and prevent pregnancy complications among pregnant women with, or at high-risk of, GDM who are experiencing food insecurity or financial hardship. This study will generate important evidence for the integration of ‘Produce Prescription’ into the healthcare system to support this population.

Research Methodology

316 pregnant women (<16 weeks’ gestation) with food insecurity and/or financial hardship, overweight/obesity and GDM, or at high-risk of GDM, will be recruited from hospitals in Sydney, Australia (Canterbury, St George, Nepean and Campbelltown Hospitals).

Women randomised to the intervention group will receive a weekly ‘Produce Prescription’ delivery to their home including fruit, vegetables, wholegrains and nuts/seeds until birth, accompanied by three dietetic sessions to promote use of the ‘Produce Prescription’ and improve diet quality. Control group participants will receive usual clinical care. Outcome assessment will occur at baseline (<16 weeks’ gestation), midpoint (24-28 weeks’ gestation), pre-delivery (34-38 weeks’ gestation) and post-delivery (prior to hospital discharge).

The primary outcome is change in gestational weight gain from baseline to pre-delivery. Secondary outcomes include a composite of adverse maternal outcomes (GDM, hypertension in pregnancy, weight gain above recommendations, caesarean section) and a composite of adverse neonatal outcome (preterm birth, large-for-gestational age, perinatal mortality). The project will also utilise a mixed-methods process evaluation with key stakeholders, including study participants, food suppliers, healthcare providers, and research staff to assess the implementation process.

Current status

We are currently recruiting for this trial from Sydney hospitals.