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The gestational diabetes future diabetes prevention study (GODDESS): A partially randomised feasibility controlled
Judith Parsons1, Rita Forde1, Anna Brackenridge2
1Care in Long Term Conditions Research Division, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, United Kingdom.
Objectives:
To assess the feasibility of an ante- and post-natal lifestyle intervention for women with gestational diabetes mellitus (GDM) to reduce type 2 diabetes risk.
Design:
A partially randomised patient preference feasibility trial.
Setting:
Diabetes antenatal clinics in two inner-London hospitals, UK.
Participants:
Pregnant women ≥18 years with a GDM diagnosis and pre-pregnancy body mass index of ≥25kg/m2.
Intervention:
Participants in the intervention group were offered four motivational interview-based sessions (two antenatally and two postnatally, at 3 and 6 months postpartum), a WhatsApp support group, a FitBit and electronic self-help resources.
Outcome Measures:
Recruitment; retention; intervention dose received; data completion; adaptions; proportion achieving ≥5% weight loss; weight change, blood glucose; blood pressure; diet, physical activity, breastfeeding and depression. Clinical outcomes were measured at baseline and 6 months postpartum.
Results:
50 participants were recruited from 155 eligible women (32% recruitment rate). Thirty-four were recruited to the intervention group (23 following randomisation (RI-group) and 11 based on preference (PI-group)); and 16 to the control group (13 randomised (RC-group) and 3 preference (PC-group)). Attrition was 44% (n = 22/50). Forty-six percent (n = 6) of the intervention group (25% (n = 2) of the RI-group and 80% (n = 4) of the PI-group) achieved ≥5% weight loss compared to 8% (n = 1) in the control group (95% confidence interval (CI) -0.69 to 0.07). Mean weight change was -2.1kg±9.0 in the intervention group (0kg±5.4 in the RI-group and -5.4kg±13.0 in the PI-group) compared to +4.4kg±4.9 in the control group (RC +4.4kg ±5.3 and PC +4.7kg ±3.1, 95% CI -12.4 to 0.2).
Conclusions:
Recruitment was feasible, but strategies to improve retention are needed. The findings suggest the intervention can support women with GDM to lose weight. The observed weight loss was primarily in women who preferred the intervention. Therefore, future trials may need to adopt a preference design and consider factors associated with preference.
Trial Registration:
Trial registration: ISRCTN52675820 https://www.isrctn.com/ISRCTN52675820?q=ISRCTN52675820&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.
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