Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial.
作者： Janani Shanthosh , Deksha Kapoor , Lakshmi K Josyula , Anushka Patel , Yashdeep Gupta
DOI: 10.1136/BMJOPEN-2020-037774
关键词: Gestational diabetes 、 Qualitative property 、 Randomized controlled trial 、 Focus group 、 Family medicine 、 Clinical trial 、 Medicine 、 Public health 、 Nonprobability sampling 、 Thematic analysis
摘要: Introduction The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational (GDM). Lifestyle InterVention IN Gestational (LIVING) Study is a randomised controlled trial low-intensity lifestyle modification programme tailored to previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. aim this process evaluation understand what worked, why, during the LIVING intervention implementation, provide additional data that will assist interpretation results. findings also inform future scale-up efforts if found be effective. Methods analysis Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed framework. Michie’s Behaviour Change Theory Normalisation Process were used guide design our qualitative tools within overall RE-AIM Mixed methods including interviews, focus groups quantitative analyses evaluate from perspectives receiving intervention, facilitators, site investigators project management staff. use datasets, administratively collected accessed monitoring visits, check lists logs, participant surveys, semistructured interviews group discussions. Interview participants recruited using maximum variation purposive sampling. We undertake thematic all data, conducted contemporaneously collection until saturation has been achieved. To triangulate team engage constant iterative comparison among various stakeholders. Ethics dissemination approval obtained respective human research ethics committees All India Institute Medical Sciences, New Delhi, India; University Sydney, Wales, Australia; site-specific each local three countries: Lanka. This includes approvals Institutional Committee King Edwards Memorial Hospital, Maharaja Agrasen Centre for Disease Control Goa College, Jawaharlal Postgraduate Education Research, Madras Diabetes Research Foundation, Christian College Vellore, Fernandez Hospital Castle Street Women, Kelaniya, Topiwala National BYL Nair Charitable Birdem General International Diarrhoeal Research. Findings documented academic publications, presentations scientific meetings stakeholder workshops. Trial registration numbers Clinical Trials Registry (CTRI/2017/06/008744); Lanka (SLCTR/2017/001) ClinicalTrials.gov (NCT03305939); Pre-results.
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