Review on a Research Proposal to the ‘Grand Challenges Program’ on Global Health

Synopsis

This critical review found the proposed work is mildly innovative; there is a clear knowledge gap on which mHealth BCC mode is most effective for improving EBF, however the idea is not new and will contribute to the existing evidence base. The critical review found that the direct and indirect potential for impact is large given that EBF for infants provides protection against infection, breastfeeding reduces number of preventable DALYs for mothers and infants, and the larger flow on effects that contribute to social and economic prosperity. Regarding the quality of the proposed work, the strengths lie in the use of an RCT, the clear methodology, and research questions and objectives, and selection of the study base. However, the limitations stemmed from the discrepancy between the study base and the intended target population (urban vs. rural), the discrepancy between the use of an existing app or development of a new one, and the need to prove the additional insights that formative research could find beyond the existing evidence base. The ethical considerations of the proposed work centred around the need to clearly outline the consent process, the identification of no participant risk, and whether it is fair to ask participants to participate in a study where the authors have not applied existing research.

Innovation

The proposed work will be set in Hanoi, Vietnam. Hanoi is Vietnam’s capital city and is situated in the north of the country. The main outcomes of the proposed work are to assess the cost effectiveness and efficacy of using mobile phones to reduce child undernutrition in rural Vietnam. Specifically, the proposed work claims to help bridge the knowledge gap of the optimal mobile behavioural change communication (BCC) mode to improve infant and young child feeding (IYCF), assessed by measuring the percentage change in number of exclusively breast-fed babies under 6 months of age. 

The proposed work contributes to an important global health concern, as noted in the proposal. Breast feeding supports and improves the health, development, and survival of young children under 2 years [1, 2] and can also provide breast feeding mothers with short- and long-term protection against postpartum depression [3]. This work also supports WHO recommendations [4] and aligns with Sustainable Development Goals 2 and 3 that aim to achieve zero hunger and good health and well-being for all [5], and one of the World Health Assembly’s 2025 Global Nutrition Targets aimed at increasing the rate of infants EBF for the first 6 months of life up to 50% [6]. 

There are a number of other studies not mentioned in the proposal that have looked at increasing exclusive breast feeding (EBF) both in Vietnam and other countries [3, 7, 8, 9, 10, 11], and also the effectiveness of mobile communications to improve EBF in Vietnam and other countries [12, 13, 14, 15]. The main outcomes of note from these studies are that there are several factors that determine the success of EBF for the first 6 months of a child’s life, such as education [7], perceived self-efficacy [3], caesarean sections and neonatal complications [8], early initiation of breast feeding (EIBF) [9], and enforcement of government breast feeding policies [10]. Additionally, the effectiveness of mobile communications to promote EBF have found that it is important to consider the readiness of mothers to accept mobile health information [12, 15], mothers and family trust in mobile health communications [13], and that the mix of in-person and mobile communications is important [14].

There is already a significant evidence base for this work to build upon. In this context, the proposed work and research question is only novel in the sense that it is exploring which combination of mobile health (mHealth) behavioural communication channels is most effective (types) for behaviour change, rather than only asking ‘is mobile communication effective?’. The proposed work will help reform current mHealth approaches by identifying the optimal channel of mobile communications. Upon extensive research, it is currently unclear which mode of mobile communications would be more effective in achieving EBF for infants under 6 months of age. 

Once the outcomes of this study are known, this work can then, theoretically, be used to increase self-efficacy or other health outcomes more efficiently through specific mobile mediums, and better promote behaviour change related to other health information (not IYCF specific) to the same population or other populations of similar characteristics. 

The proposed work has been made in a compelling way as it has clearly highlighted the gap in the research relating to specific mobile health communication channels for improving IYCF practices and the benefits of this outcome. However, the contribution of this proposed work to the existing evidence base was not immediately clear as the authors did not highlight the mHealth and EBF studies that have already been conducted in Vietnam (and Hanoi), nor demonstrate how this work would build upon the studies already conducted. Additionally, the future generalisability of the study results for future use has not been elaborated upon. Overall, there is clearly a need for this study to be conducted to fill the knowledge gap of which mHealth BCC mode is most effective to improve EBF. 

Potential for Impact

The research outlining the benefits of EBF for the first 6 months of life are clear for both mother and child. Exclusive breast feeding, with no other complimentary liquids or solids, is the most effective form of nutrition for an infant in their first months of life [3] as breast milk contains comprehensive nutrients including antibodies that fight inflammation and infection [16]. When comparing infants who are EBF for the first 6 months of life against infants who are not EBF, the longer-term health and economic benefits are also clear. Benefits have been shown to include higher rates of infant survival [17], and higher intelligence quotients [18]. For the mother who EBF’s for at least the first 6 months of life, the short-term benefits include reduced risk of postpartum haemorrhage, infection, and depression, temporary postnatal infertility (termed lactational amenorrhea), increased rates of weight loss, and reduced levels of stress and anxiety [19, 20, 21]. Longer-term benefits for the mother can also include protection against ovarian cancer, breast cancer, hypertension, obesity, and type 2 diabetes [10, 22, 23]. Overall, EBF for the first 6 months of life has been shown to reduce the number of preventable disability adjusted life years (DALYs) for mothers and infants [10]. 

As there have been declining rates of breast feeding in Vietnam, and less than 9% of Vietnam hospitals meet the Baby Friendly Initiative aimed at giving infants the best start at life [24], the proposal will directly address aspects of health inequity by giving children a better chance of survival and improving mothers’ short- and long-term health. The proposal will also identify the best, most effective, mHealth communicate mode to better target communications and achieve the best results of increasing the percentage of EBF infants up to 6 months. 

The proposal has also noted other indirect impacts that could be achieved by improving EBF practices globally. These include preventing >800,000 child deaths, including almost 50% of child deaths resulting from diarrhoea and up to one third of child deaths due to respiratory infection, and preventing up to 20,000 deaths resulting from breast cancer every year. 

Practically, the costs of Vietnamese mothers not breastfeeding would have a significant negative impact on Vietnamese health services and the national economy [25, 26]. 

If successfully implemented, the proposed work will also see broader social, economic, and environmental benefits for Vietnam. Healthy young people are more likely to be productive members of society and can therefore actively contribute to their family’s economic security and livelihood [27]. Further economic benefits can also be shared by the mother and her family by avoiding the expense of infant formula and the necessary bottles and other instruments used to feed infants with complimentary liquids [24]. Health is also directly linked to social benefits, whereby employment status and household income can dictate the level of social inclusion or exclusion [28]. Other social and economic benefits include improving the mother’s education on maternal and infant nutrition, which can lead to long term health benefits for both the immediate family and the wider community if the information is shared. EBF is also beneficial for the environment as breast milk is not manufactured industrially and therefore does not produce waste that the planet cannot breakdown, such as infant formula [29]. 

Quality

The quality of the proposed work has both strengths and limitations. 

In regard to the design of the proposed work, the authors have chosen to use a cluster randomised trial where participants are equally matched on a 1:1:1:1 basis. Randomised controlled trials (RCTs) are considered to provide the highest level of evidence for an original research study [30]. The use of an RCT is a significant strength in this study as it will enable the authors to provide the most reliable evidence for the effectiveness of specific modes of BCC for increasing the percentage of infants EBF for the first 6 months of life in Hanoi. Another strength of an RCT is that the nature of randomisation controls for bias or confounding factors that may influence the results [31]. This ensures that the groups of the study are as similar as possible at the start of the study and any unknown or unmeasured factors between the groups are balanced to allow for equal comparison of the effectiveness of the study exposure. 

Due to the nature of the study, the authors note that it is not possible to blind participants to which intervention they will receive. Instead, the authors have blinded the outcome assessors of both the trial hypotheses and intervention details to reduce any risk of assessor bias. This is a noteworthy adaptation to account for lack of double blinding. 

The methodology of the proposed work is clear in outlining the randomisation method (sequential recruitment from all mothers presenting at antenatal care), the inclusion and exclusion criteria, and analysis by intention to treat. However, the proposed work states the need to request consent yet fails to provide the means of collecting participant consent. This is a weakness in the methodology description and potential ethical issue if consent is not sought properly. 

The selection of the study base is another strength. The Hanoi Obstetric Hospital is the main tertiary hospital in Hanoi for obstetric care, which will enable the authors to claim that they have taken a random sample of women that are representative of Hanoi. This is an important strength of the study and will enable the authors to generalise their results to populations of similar characteristics. 

The research questions and objectives of the study are clear, i.e., identifying which mode of BCC is most effective in achieving an increased rate of EBF in infants for first 6 months of life. The identified primary and secondary outcomes of the study are appropriate to measure the research question between study groups. However, certain secondary outcomes may be prone to recall bias due to the need for investigators to rely on the mother’s memory, leading to a potential weakness of the study, unless controlled for in a way that is not mentioned in the proposal. 

A potential strength of the proposed work is the inclusion of formative research using mixed methods (qualitative and quantitative). The formative research is claimed to assess the cultural appropriateness and clarity of the BCC to participants, as well as identifying behaviour determinants and contributing factors to EBF. This formative research will ensure the effectiveness of the trial intervention and is a strength in this sense, however the authors have failed to note that there is already an abundance of research on those topics already [3, 7, 8, 9, 10, 11, 12, 13, 14, 15] and have not used the existing evidence as a base to build upon. As the authors primary objective and research outcome is not in relation to these factors, the need to conduct formative research will need to be proven further. This is a weakness of the study design and potentially an unnecessary cost of the trial. Additionally, the references used in the proposed work have not included the most recent studies conducted on EBF and BCC in both Vietnam and other LMICs [3, 7, 8, 9, 10, 11, 12, 13, 14, 15].

Additionally, there is a potential discrepancy between the objectives of the study and the study methodology. The authors state that the proposed trial will evaluate the cost effectiveness and efficacy of BCC in reducing child undernutrition in rural Vietnam, however, the study base is located in Hanoi, the capital of Vietnam and an urban city. The methodology and outcomes will answer the research question as it applies in an urban setting, however the authors have not accounted for the different characteristics of rural Vietnamese mothers and therefore cannot generalise the results for rural Vietnam [15]. 

Lastly, the proposed work has given due attention to the technological opportunities provided in this study by outlining the rapid adoption of mobile phones in Vietnam and main user group of mobile phones (ages 18-34) which happens to align with the minimum age for participant eligibility in the study. However, the authors claim that mHealth interventions have not been widely applied for IYCF communications [32], yet the authors also claim to base the study done on a trial of short mobile phone messages to improve EBF and IYCF in Myanmar [33]. Whilst the definition of ‘widely applied’ can be argued, the discrepancy remains of note. Additionally, the proposed work claims to use the formative research as an opportunity to field-test the app, however the authors have failed to note whether the study includes all brands of mobiles or not. Other studies have already conducted similar mHealth BCC to improve EBF in Vietnam and outlined the use of both iOS and Android apps [10]. Lastly, there is a further discrepancy between whether the proposed work will be using the smart app already developed and in use in the Myanmar study [33], or whether the study will develop a smart app similar to the already developed app from Myanmar. The proposed work should clarify the above discrepancies to provide a clearer description of the trial intervention and note how previous work will be leveraged in this study. 

Ethical Considerations

The proposed work has not outlined or mentioned any ethical considerations in relation to the study. Similar studies on improving breastfeeding in Vietnam have outlined their consent process and ability for participants to withdraw from the study at any time or decline to answer any questions without prejudice [10]. The authors have failed to mention both aspects as part of the study design which could lead to ethical concerns if not addressed. 

The reference study [10] also outlined that no participants would be at risk by participating in the study, nor would they miss out on any standard hospital practice of care. Whilst the proposed work states that one study group, the control group, will receive usual healthcare services from Hanoi Obstetric Hospital, it is not explicitly stated that no participants will be at risk by participating in the study.

As previously mentioned, the proposed work fails to build upon the existing data base that may prove the need for formative research obsolete. Whilst it would not be unethical to conduct the formative research, as it was ethical for the other studies to conduct the same research, there remains the question of whether it is fair for Vietnamese mothers to participate in the formative research when the authors have not duly applied all available research in the study design. 

Also previously mentioned, the proposed work aims to improve rural child undernutrition, yet the study design does not include a representative sample of rural mothers. Whilst a study design flaw, this is also an ethical issue if the results are intended to be applied to a population whose characteristics have not been accounted for in the study. 

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