{
  "abstract": "Introduction 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.Methods and analysis This will be a multicentre, randomised, open-label interventional pilot study. Using a 2×2 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.Ethics and dissemination 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).Trial registration number Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.",
  "authors": [
    {
      "affiliations": [
        "Cardiovascular Programme, The George Institute for Global Health, Sydney, New South Wales, Australia",
        "Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, New South Wales, Australia"
      ],
      "name": "Angela Xun-Nan Chen"
    },
    {
      "affiliations": [
        "Cardiovascular Programme, The George Institute for Global Health, Barangaroo, New South Wales, Australia"
      ],
      "name": "Vivian Y Lee"
    },
    {
      "affiliations": [
        "Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Katherine Donges"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, Barangaroo, New South Wales, Australia"
      ],
      "name": "Chris Giancas"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, Barangaroo, New South Wales, Australia"
      ],
      "name": "Blake Angell"
    },
    {
      "affiliations": [
        "UNSW Medicine and Health Lifestyle Clinic, University of New South Wales, Sydney, New South Wales, Australia",
        "Discipline of Sport and Exercise Science, School of Health, University of the Sunshine Coast - Sunshine Coast Campus, Sippy Downs, Queensland, Australia"
      ],
      "name": "Belinda Parmenter"
    },
    {
      "affiliations": [
        "Obstetric Medicine, Royal Hospital for Women, Randwick, New South Wales, Australia",
        "Discipline of Women’s Health, School of Clinical Medicine, University of New South Wales Medicine and Health, Sydney, New South Wales, Australia"
      ],
      "name": "Helen L Barrett"
    },
    {
      "affiliations": [
        "Discipline of Women’s Health, School of Clinical Medicine, University of New South Wales Medicine and Health, Sydney, New South Wales, Australia",
        "Women’s Health Programme, The George Institute for Global Health, Barangaroo, New South Wales, Australia",
        "Department of Obstetrics and Gynaecology, St George Hospital, Kogarah, New South Wales, Australia"
      ],
      "name": "Amanda Henry"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, Barangaroo, New South Wales, Australia"
      ],
      "name": "Anushka Patel"
    },
    {
      "affiliations": [
        "Cardiovascular Programme, The George Institute for Global Health, Barangaroo, New South Wales, Australia",
        "Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia",
        "Department of Cardiology, St Vincent’s Hospital Sydney, Darlinghurst, New South Wales, Australia"
      ],
      "name": "Clare Arnott"
    }
  ],
  "title": "DIVINE–pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in Australia",
  "uid": "72f8add4-8656-58dd-a4aa-2aa0708c3e3d"
}