Development, Implementation, and Process Evaluation of Bukhali: An Intervention from Preconception to Early Childhood

Abstract

The Healthy Life Trajectories Initiative, an international consortium developed in partnership with the World Health Organization, is addressing childhood obesity from a life-course perspective. It hypothesises that an integrated complex intervention from preconception, through pregnancy, infancy and early childhood, will reduce childhood adiposity and non-communicable disease risk, and improve child development. As part of the Healthy Life Trajectories Initiative in South Africa, the Bukhali randomised controlled trial is being conducted with 18–28-year-old women in Soweto, where young women face numerous challenges to their physical and mental health. The aims of this paper were to describe the intervention development process (including adaptations), intervention components, and process evaluation; and to highlight key lessons learned. Intervention materials have been developed according to the life-course stages: preconception (Bukhali), pregnancy (Bukhali Baby), infancy (Bukhali Nana; birth—2 years), and early childhood (Bukhali Mntwana, 2–5 years). The intervention is delivered by community health workers, and includes the provision of health literacy resources, multi-micronutrient supplementation, in-person health screening, services and referral, nutrition risk support, SMS-reminders and telephonic contacts to assist with behaviour change goals. A key adaption is the incorporation of principles of trauma-information care, given the mental health challenges faced by participants. The Bukhali process evaluation is focussing on context, implementation and mechanisms of impact, using a mixed methods approach. Although the completion of the trial is still a number of years away, the documentation of the intervention development process and process evaluation of the trial can provide lessons for the development, implementation, and evaluation of such complex life-course trials.

Navigating relationship dynamics, pregnancy and fatherhood in the Bukhali trial: a qualitative study with men in Soweto, South Africa

“…The intervention is delivered by trained community health workers, and is described in detail elsewhere. 22 The Bukhali process evaluation is focussing on context, implementation and mechanisms of impact, aligning with guidance from the UK MRC on process evaluation. 23 This context includes participants' lived experiences, as well as their family, community, and social environment, 22 of which their partner and father of their baby (if they fall pregnant) are a critical component.…”

“…22 The Bukhali process evaluation is focussing on context, implementation and mechanisms of impact, aligning with guidance from the UK MRC on process evaluation. 23 This context includes participants' lived experiences, as well as their family, community, and social environment, 22 of which their partner and father of their baby (if they fall pregnant) are a critical component. Qualitative research methods are predominantly used in the Bukhali process evaluation in order to explore the complexities of context, implementation and mechanisms of impact.…”

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of theBukhalirandomised controlled trial

“…Bukhali was developed with the goal of functioning within and complementing the realities of the South African public healthcare sector, and within Soweto, an urban, predominantly low-income setting in Johannesburg. Young women living in Soweto have been found to face a number of challenges in terms of their physical and mental health (9,10). In order to maximise the applicability and relevance of the intervention, a pragmatic approach has been adopted to the trial design (10,11), allowing for the incorporation of new learnings as the trial is implemented, and for adaptability in the face of challenges inherent to the trial context (8).…”

“…Young women living in Soweto have been found to face a number of challenges in terms of their physical and mental health (9,10). In order to maximise the applicability and relevance of the intervention, a pragmatic approach has been adopted to the trial design (10,11), allowing for the incorporation of new learnings as the trial is implemented, and for adaptability in the face of challenges inherent to the trial context (8).…”

“…Intervention development was guided by formative work conducted with community members (5,8,10,14,15). Engagement with trial stakeholders (e.g.…”