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

Abstract

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 .

Keywords: Complex behavioural change intervention; E-health; Lifestyle intervention; Malaysia; Motivational counselling; Pre-conception; Pre-pregnancy.

Figures

Fig. 1

The flow diagram of the Jom Mama trial

Fig. 2

Screen shot from the web application, showing the couples’ dashboard. Screen shot a Shows the overview of all couples under one community health promoter (CHP). The traffic lights give an indication on how active the couple are in performing their selected challenges. The second column indicates when the couple was last active on the mobile application. The last column informs when the CHP has the next appointment with the couple. Screen shot b Shows the progress over time for one couple. The graphic can shift between wife and husband and, in this example, it is only showing the wife. The upper columns indicate how many times the challenges have been performed per month. The lower columns indicate how many times each challenge has been performed

Fig. 3

Screen shots of mobile application. a The main screen, showing the couple’s process for the particular month. The icons on top illustrate the categories of the different challenges selected (two physical activity challenges and one healthy eating challenge). In the middle, is the progress bar, showing the progress of the user and her spouse for this particular month. Lowest, are the selected challenges listed and how many times they should be performed in one week. b By tapping on the challenges, a description of the different challenge is showing (example of the healthy eating challenge). c When the challenge has been performed, the subject will ‘check-in’, and by doing that be awarded 2 points for performing the challenges. d A timer can be set for each challenge, so a reminder will be send to the subject on the given time to perform the challenge. e The subject is selecting the challenge out of a list set challenges. f The Flash challenge is a bonus challenge, which the subject can select when it becomes available. This occurs randomly during the intervention period. The Flash challenge will give extra points