239 Trial profile: community enabled readiness for first 1000-days learning ecosystem (CRADLE)

Background The first 1000 days presents a unique opportunity to enhance a child’s ability to grow, learn and thrive which will have a long term impact in a child’s future. Objectives The Community enabled ReAdiness for first 1000-Days Learning Ecosystem (CRADLE) is a trial designed to develop a self-learning eco-community from pregnancy to early-childhood to promote parenting self-efficacy (PSE) and improve health outcomes for first-time families. Here, we describe the trial protocol and provide updates thus far. Methods CRADLE is a parallel, three-arm randomised controlled trial which targets to recruit 750 pregnant women from KK Women’s and Children’s Hospital (KKH), Singapore. Participants are randomly assigned to receive: (1) standard routine care; (2) behavioural nudges and engagement via a social media platform; or (3) midwife-led continuity care involving direct individual engagement with midwives throughout pregnancy, to 6-month post-delivery. We hypothesize that the use of virtual targeted nudging tool in the form of text messages along with social media (arm 2), or face-to-face care from midwives supplemented with individualised teleconferencing sessions (arm 3) in the first 1000 days will lead to a better maternal PSE and health outcomes in both mother-child, compared with those who are receiving standard routine care (arm 1). The primary outcome is PSE, while the secondary outcomes include birth experience, mental wellness, feeding practice and nutritional status of mother-child. Participants are followed-up from recruitment visit (early-mid pregnancy) until child turns two years of age. Intention-to-treat and per-protocol analyses will be performed using general linear models to test the effects of interventions across three arms. Results The trial was launched on 1 July 2020. As of 21 December 2020, a total of 60 participants were recruited with 2 of them withdrawn due to miscarriage. Currently, 14 participants have reached the postnatal stages. Participants’ baseline socio-demographic characteristics were similar across three arms, with the mean age of 31 years old, and the mean gestation of 18.1 weeks, at the time of recruitment. In terms of ethnicity, majority of recruited patients were Chinese (71.7%), followed by Malay (8.3%), Others (11.7%) and Indian (8.3%). 90% of the participants were employed, and over 70% of the participants attained tertiary education qualifications. Conclusions Despite recruitment delay of a few months due to COVID-19, the team was able to recruit 60 participants over 5 months with strict safe distancing measures. Multiple strategies have been established to facilitate the recruitment including extending publicity of the programme within and outside of KKH. The team will initiate preliminary data once 100 participants have been recruited. To engage existing participants, CRADLE will hold its first health education webinar in January 2021. This study may identify a sustainable strategy in the community by helping first-time parents to have a positive experience during the pregnancy, childbirth and parenthood, leading to enhanced PSE and health outcomes for both mother and child.