Effectiveness of a complex, pre-conception intervention to reduce the risk of diabetes by reducing adiposity in young adults in Malaysia:The Jom Mama project - A randomised controlled trial

Background: Pre-conception interventions have the potential to lower non-communicable disease risk in prospective parents and reduce transmission of risk factors such as obesity to the next generation. The Jom Mama project in Malaysia investigated the effectiveness of a combined behaviour change communication and e-health intervention in young married couples prior to first pregnancy. This paper reports the evaluation of the effectiveness of this trial. Methods: Jom Mama was a non-blinded, randomised controlled trial (RCT) conducted in Seremban, Malaysia, over a period of 33 weeks, covering six contact points between trained community health workers and newly married couples before the conception of a first child. Out of 2075 eligible nulliparous women, 549 participated and 305 completed the intervention, with 145 women in the intervention and 160 in the control group. The intervention group received a complex behavioural change intervention, combining behaviour change communication provided by community health promoters and access to a habit formation mobile application, while the control group received the standard care provided by public health clinics in Malaysia. The primary outcome was a change in the woman's waist circumference. Secondary outcomes were anthropometric and metabolic measures, dietary intake (Food Frequency Questionnaire, FFQ), physical activity (International Physical Activity Questionnaire, IPAQ) and mental health (Depression Anxiety Stress Scale, DASS 21). An extensive process evaluation was conducted alongside the trial in order to aid the interpretation of the main findings. Results: There were no significant differences of change in the woman's waist circumference between intervention and control groups at the start and end of the intervention. While the weight, waist circumference and Body Mass Index (BMI) of women in both groups increased, there was a significantly lower increase in the intervention vs the control group over the period of the trial among women who are obese (0.1 kg vs 1.7 kg; P = 0.023, in the intervention and control group respectively). In terms of BMI, the obese intervention subgroup showed a slight reduction (0.01) compared to the obese control subgroup whose BMI increased by 0.7 (P = 0.015). There were no changes in the other secondary outcomes. Conclusions: The Jom Mama pre-conception intervention did not lead to a reduction in waist circumference or significant changes in other secondary outcomes over the eight months prior to conception. However, there was a significantly smaller weight gain in the intervention vs the control group, predominantly in women with pre-existing obesity

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

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.</p

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

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.</p

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

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.</p

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

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.</p

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial

BACKGROUND: Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. METHOD/DESIGN: Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. DISCUSSION: This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693

Economic burden of hypoglycemia for type II diabetes mellitus patients in Malaysia.

This study mainly aims to identify the direct cost and economic burden of hypoglycemia for patients with type II diabetes mellitus in Malaysia. A cross-sectional study explored the cost incurred for hypoglycemia among patients admitted to University Kebangsaan Malaysia Medical Centre (UKMMC). The study covered patients aged 20-79 years hospitalized with a primary diagnosis of ICD-10 hypoglycemia and discharged between January 2010 and September 2015 according to the casemix database. A costing analysis was done through a step-down approach from the perspective of health providers. Cost data were collected for three levels of cost centers with the help of a hospital-costing template. The costing data from UKMMC were used to estimate the national burden of hypoglycemia among type II diabetics for the whole country. Of 244 diabetes patients admitted primarily for hypoglycemia to UKMMC, 52% were female and 88% were over 50 years old. The cost increased with severity. Managing a hypoglycemic case requires five days (median) of inpatient stay on average, with a range of 2-26 days, and costs RM 8,949 (USD 2,289). Of the total cost, 30% related to ward (final cost center), 16% to ICU, and 15% to pharmacy (secondary-level cost center) services. Considering that 3.2% of all admissions were hypoglycemia related, the total annual cost of hypoglycemia care for adult diabetics in Malaysia is estimated at RM 117.4 (USD 30.0) million, which translates to 0.5% of the Ministry of Health budget. Hypoglycemia imposes a substantial economic impact even without the direct and indirect cost incurred by patients and other cost of complications. Diabetic management needs to include proper diabetic care and health education to reduce episodes of hypoglycemia

Pre-pregnancy community-based intervention for couples in Malaysia: application of intervention mapping

Abstract Background Malaysia is experiencing a nutrition transition with burgeoning obesity, particularly in women, and a growing prevalence of non-communicable disease. These health burdens have severe implications not only for adult health but also across generations. Pre-conception health promotion could address the intergenerational risk of metabolic disease. This paper describes the development of the “Jom Mama” intervention using Intervention Mapping (IM). The Jom Mama intervention aims to improve the health of young adult couples in Malaysia prior to conception. Methods IM comprises of five steps prior to the last one, which involves the evaluation of the intervention. We used the five steps to develop the Jom Mama intervention. Results Both the process and evidence is documented providing the rationale to the selection of the key objectives of the intervention: (i) increasing healthy dietary practice; (ii) increasing physical activity levels, (iii) reducing sedentary activity; and (iv) improving social support to offset stressful lifestyles. From the IM process, Jom Mama will be health-system centred approach that uniquely combines both community health promoters and an electronic-health platform to deliver the complex intervention. Conclusion IM is an iterative process that systematically gathers “best” evidence, selects appropriate theories of behaviour change, and facilitates formative research so as to develop a complex intervention. Though the IM process is time consuming, complex, and costly, it has enriched the Jom Mama intervention with a number of notable advantages: (i) intervention fashioned on formative work with stakeholders and in the target group; (ii) intervention combines research evidence with theory; (iii) intervention acknowledges multiple dynamics of influence; and (iv) intervention is embedded within health service priorities in Malaysia for greater scale-up possibility