The gestational diabetes future diabetes prevention study (GODDESS): A partially randomised feasibility controlled trial

• DOI: 10.1371/journal.pone.0273992
• Publication Date: 2022-12-30T18:51:58Z
• Authors: Judith Parsons; Rita Forde; Anna Brackenridge; Katharine F. Hunt; Khalida Ismail; Trevor Murrells; Anna Reid; Helen Rogers; Rebecca Rogers; Angus Forbes
• Keywords: Weight change

Objectives To assess the feasibility of an ante- and post-natal lifestyle intervention for women with gestational diabetes mellitus (GDM) to reduce type 2 risk. Design A partially randomised patient preference trial. Setting Diabetes antenatal clinics in two inner-London hospitals, UK. Participants Pregnant ≥18 years a GDM diagnosis pre-pregnancy body mass index ≥25kg/m . Intervention group were offered four motivational interview-based sessions (two antenatally postnatally, at 3 6 months postpartum), WhatsApp support group, FitBit electronic self-help resources. Outcome measures Recruitment; retention; dose received; data completion; adaptions; proportion achieving ≥5% weight loss; change, blood glucose; pressure; diet, physical activity, breastfeeding depression. Clinical outcomes measured baseline postpartum. Results 50 participants recruited from 155 eligible (32% recruitment rate). Thirty-four (23 following randomisation (RI-group) 11 based on (PI-group)); 16 control (13 (RC-group) (PC-group)). Attrition was 44% (n = 22/50). Forty-six percent 6) (25% 2) RI-group 80% 4) PI-group) achieved loss compared 8% 1) (95% confidence interval (CI) -0.69 0.07). Mean change -2.1kg±9.0 (0kg±5.4 -5.4kg±13.0 +4.4kg±4.9 (RC +4.4kg ±5.3 PC +4.7kg ±3.1, 95% CI -12.4 0.2). Conclusions Recruitment feasible, but strategies improve retention are needed. The findings suggest can lose weight. observed primarily who preferred intervention. Therefore, future trials may need adopt design consider factors associated preference. Trial registration registration: ISRCTN52675820 https://www.isrctn.com/ISRCTN52675820?q=ISRCTN52675820&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search