Community-based lifestyle intervention using targeted shared care approach versus usual care on pregnancy outcomes in Nigerian women with gestational diabetes mellitus (ALEVIATE GDM): study protocol for a randomized controlled trial v1

Background: The purpose of the study is to evaluate the effectiveness of a targeted shared care approach in the treatment of GDM as well as to increase community awareness for early registration for antenatal care and those of healthcare workers about screening and management of GDM. Methods: The randomized controlled trial will be conducted in the University of Nigeria Teaching Hospital (UNTH), Nigeria and extended to other primary, secondary, and tertiary health care facilities in South-East region and neighbouring communities of Nigeria. Participants will be followed up from baseline to 3 months post-delivery. Questionnaires (WHO-BREF, SF-36, GPAQ, PHQ9, Spielberger STAI, and Edinburgh Postnatal Depression Scale), Clinical (anthropometry, BP), ultrasonography (foetal parameters) and laboratory (urinalysis, glycaemia and lipids) data will be collected at recruitment and at intervals. Data on effects of education/awareness created and training of healthcare workers will be collected. Intervention would include usual care of general health talks on diet and exercise for control group. Shared care involving usual care plus individualized weight optimization counselling; dietary recall and self-monitoring of glucose. Primary outcomes include glycaemic control, birth weight ≥4000grams, registration for antenatal care and awareness of health workers. Secondary outcomes will include incident pregnancy-induced hypertension, perinatal complications, and community awareness. Discussion: GDM screening and care at primary and secondary health facilities are almost non-existent. Hence the significance of this study would be in provide data on the utility of universal GDM screening as well as generate more representative up-to-date data for future planning and advocacy. Study findings shall be disseminated at conferences and peer-reviewed journals. Trial Registration: Pan African Clinical Trial Registry (PACTR201804003328818), Registered April 2018, Protocol Identifier: BR2-R1-GDM1.