Learning from the process evaluation of a complex, pre-conception randomised controlled trial in Malaysia: the Jom Mama project

Abstract

Background Seen from a life-course perspective, pre-conception interventions are essential to reduce transmission to the next generation of obesity as a risk factor for later non-communicable diseases. The Malaysian Jom Mama project investigated the effectiveness of a combined behaviour change communication and e-health intervention in young married couples prior to first pregnancy. This paper reports on the extensive process evaluation (PE) that accompanied the Jom Mama trial. Methods In accordance with the realistic evaluation approach, a programme theory was developed for the Jom Mama project, based on key functions selected for six PE sub-studies, namely: recruitment; attrition; behaviour change communication (BCC); e-health (the Jom app); peer-support for community health promoters (CHPs); and contextual factors. The results of the first four sub-studies are reported here. Three cycles of data collection were conducted based on triangulation and a mixed-methods approach. Results The findings permitted distinguishing between theory and implementation challenges in interpreting the outcome of the Jom Mama trial.1 Recruitment and attrition proved to be challenges, and although the PE allowed Jom Mama investigators to improve procedures in order to achieve a sufficient sample size, it also has implications for engaging this age group in future pre-conception interventions. PE sub-studies showed that there were challenges in applying the BCC, and that the uptake of the Jom app varied. In one way this can be seen as an indication of limited fidelity, but it also leads to questions about how best to change the communication culture within the Malaysian health care system. Conclusions The Jom Mama PE highlighted the challenges of recruiting newly-wed couples for a pre-conception intervention. Despite thorough intervention development preparations, the PE revealed the difficulty of lifestyle behaviour change through Malaysian community health wokers who were trained on new communication strategies combined with e-health solutions, and that six intervention sessions of eight months do not constitute a sufficient dose to affect change. <div style=“page-break-after: always;”></div>