Pilot Randomised Controlled Trial - Nurture Early for Optimal Nutrition (NEON) Study: Community facilitator-led participatory learning and action (PLA) women's groups to improve infant feeding, care and dental hygiene practices in South Asian infants aged < 2 years in East London

Background: The first 1000-days of life are a critical window and can result in adverse-health consequences due to inadequate nutrition. South-Asian (SA) communities face significant health-disparities, particularly in maternal and child-health. Community-based-interventions, often employing Participatory-Learning-and-Action (PLA) approaches, have effectively addressed health-inequalities in lower-income-nations. The aim of this study was to assess the feasibility of implementing a PLA-intervention to improve infant-feeding and care-practices in SA communities in London. Methods: Comprehensive-analyses were conducted to assess the feasibility/fidelity of this pilot-randomised-controlled-trial. Summary-statistics were computed to compare key-metrics (participant consent-rates, attendance, retention, intervention-support, perceived-effectiveness) against predefined-progression-rules guiding towards a definitive-trial. Secondary-outcomes were analysed, drawing insights from sources, such as The-Children's-Eating-Behaviour-Questionnaire (CEBQ), Parental-Feeding-Style-Questionnaires (PFSQ), 4-Day-Food-diary, and the Equality-Impact-Assessment (EIA) tool. Video-analysis of children's mealtime behaviour trends was conducted. Feedback-interviews were collected from participants. Results: Process-outcome measures met predefined-progression-rules for a definitive-trial which deemed the intervention as feasible. The secondary-outcomes analysis revealed no significant changes in children's BMI z-scores. This could be attributed to the abbreviated follow-up period of 6-months, reduced from 12-months, due to COVID-19-related delays. CEBQ analysis showed increased food-responsiveness, along with decreased emotional-over/undereating. A similar trend was observed in PFSQ. The EIA-tool found no potential discrimination areas, and video-analysis revealed a decrease in force-feeding-practices. Participant-feedbacks revealed improved awareness and knowledge-sharing. Conclusion: The study validates the feasibility of a community-oriented, co-adapted Participatory-Learning-and-Action approach for optimising infant-care among South-Asians in high-income countries. It underscores the potential of such interventions in promoting health-equity and improving health-outcomes. Further research is required to evaluate their wider impact. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial IRAS-ID-296259 ([ISRCTN10234623][1]) ### Funding Statement Logan Manikam & Priyanka Patil were funded via a National Institute for Health Research (NIHR) Advanced Fellowship (Ref: NIHR300020) to undertake the Pilot Feasibility Cluster Randomised Controlled Trial of the NEON programme in East London. Prof Monica Lakhanpaul was funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study has obtained ethical approval from UCL Research Ethics Committee [Ethics ID 17269/001], Sponsor reference number: 142600, Funding Reference: NIHR300020 and IRAS number: 296259, Ref: 21/SW/0142. Study protocols and relevant documents were reviewed by UCL Research Ethics Committee, NHS Health Research Authority (HRA) and study partners involved in establishing data sharing agreement for linking participants’ routine data (Tower Hamlets GP Care Group, London Borough of Newham Council). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN10234623