A cluster randomized controlled trial of small quantity lipid based supplements versus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study.

doi:10.21203/rs.3.rs-2477447/v1

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Study protocol

A cluster randomized controlled trial of small quantity lipid based supplements versus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study.

https://doi.org/10.21203/rs.3.rs-2477447/v1

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published 10 Feb, 2024

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Background: Chronic malnutrition is a condition that can have important negative impacts on subsequent physical and cognitive development. It is multi-causal and can start very early in life, already in utero, thus it is especially challenging to find appropriate interventions to tackle it. The supplementation with small quantity lipid based nutrients (SQ-LNS) and the provision of cash transfers are promising interventions to prevent it but more operational research is needed to gain evidence on their effectiveness.

Methods/Design: The Crescer project aims to evaluate the impact of a SQ-LNS intervention and a cash transfer intervention in the lineal growth of children less than 2 years old in Southern Angola. The three-arm parallel cluster randomised controlled trial is set in four comunas of Huila and Cunene provinces. Pregnant women are recruited, and treatment arms receive unconditional cash or SQ-LNS plus a food family ration for the first 1000 days, from pregnancy through the child reaching 24 months. A comparison group receives “standard of care” provided by the Crescer project to which all groups have the same access. The primary outcome is the prevalence of stunting measured as height-for-age Z-score (HAZ) < -2 in children below 2 years. Impact will be assessed at 3, 6, 12, 18 and 24 months of children’s age. Secondary outcomes include mortality, morbidity, caring, hygiene and nutrition behaviours and practices, and women and children’s dietary diversity. Quantitative data are also collected on women’s empowerment, household food security, expenditure and relevant clinical and social events at base line, end line and intermediate time points.

Discussion: The results of this trial will provide valuable information on the impact of a SQ LNS and an unconditional cash transfer intervention, carried out during the first 1000 days, in the children´s growth up to 2 years, and related outcomes.

Trial registration: Clinical Trials NCT05571280. Registered 7 October 2022.

Stunting

Children

Pregnant women

Cash transfer

Food supplementation

SQ-LNS

Angola

Randomised control trial

Research protocol

Background and rationale

Stunting or low height-for-age among children under five years of age is an indicator of growth faltering associated with chronic malnutrition, a condition that can have important negative impacts on subsequent physical and cognitive development (1).

According to the most recent estimates, there are still 149 million children under five years of age affected by stunting globally (accounting for 22% of all children under five years) and Africa is the region showing the highest prevalence (30.7%)(2).

The determinants of stunting and other forms of malnutrition, as well as the interventions needed to combat them were summarized in the 2008 and 2013 Lancet Series on maternal and child nutrition (3) (4). The most direct determinants or immediate causes are inappropriate dietary intake and diseases that are influenced by the intermediate causes, grouped in caring practices, food security, and access to water, sanitation and health services. These in turn are grounded on the basic or structural causes comprising poverty, education, and lack of basic community resources, among others (5). The Series also outlined several effective interventions mostly tackling immediate causes, the so-called nutrition-specific interventions (6), but also emphasized the need to go beyond and address the intermediate and basic causes through the nutrition-sensitive interventions (7) (8). These latter interventions have a nutrition goal but are implemented from different sectors such education, water and sanitation, agriculture or social safety nets, among others.

In relation to stunting more specifically, the evidence compiled highlighted the need to focus on prevention, with interventions targeting pregnancy and the first two years of children’s lives, known as the “1000 days” period (9). This is related to the fact that stunting begins very early in life (in utero) and generally continues during the first two postnatal years, with most of the decline in length-for-age occurring during the complementary feeding period, between 6 and 24 months of age (10).

In 2021 the evidence of the Lancet Series was expanded by the revision of effectiveness of newer interventions (11). Among the nutrition-specific interventions stood out the supplementation with small-quantity lipid-based nutrients (SQ-LNS) for the improvement of child growth (12), and for stunting reduction among new borns by the provision of SQ-LNS to the pregnant women (13).

In relation to nutrition-sensitive interventions there is emerging interest in the effectiveness of cash-based transfers for preventing malnutrition, as it is a public health strategy that has proven effectiveness on improving household food security (8), child health outcomes (14), and children’s growth (15) .

In Angola, the prevalence of stunting is 38% with large disparities across geographical areas of the country and within diverse agro-ecological zones (16). Moreover, persistent food security and nutritional crisis caused by cyclical phenomena of droughts and floods have affected the southern provinces of Angola in recent years, resulting in around 50% of communes classified as Crisis levels of food insecurity and Very high levels of malnutrition (17).

The goal of this study is to generate evidence on the effectiveness of nutrition specific and nutrition sensitive interventions in the prevention of growth retardation, in Southern Angola.

More specifically, the MuCCUA study (“Mother and Child Chronic Undernutrition in Angola” Study) aims to assess and compare the effectiveness of a SQ-LNS supplementation intervention and a cash transfer intervention on the prevention of growth retardation during the first 1000 days of life in two southern provinces of Angola (Huila and Cunene).

The study is part of the project Crescer, one of the components of the FRESAN (Fortalecimento da Resiliência e da Segurança Alimentar e Nutricional em Angola) program, an EU initiative to strength resilience and food and nutrition security in Southern Angola.

Study participants

The study population are pregnant women over 16 years of age living in the selected clusters, and their new born children. The target population of the interventions are all the members living in the household where the pregnant woman lives. In the study area, a household or agregado familiar is defined as the group of people, with or without kinship relationships, that usually live together under the same roof, and for at least 6 months (or less than 6 months, but with the intention of staying in the residence for the next 6 months), and share food and/or other vital needs, and their house.

All pregnant women living in the selected cluster will be included in the study.

Study clusters

The number of pregnant women to be recruited in each cluster was set at 40, and the size of the cluster defined by the number of women expected to be encountered within the population. We used as pregnancy prevalence the 3,72% provided by local health authorities[1], and thus cluster size was around 1075 people or 215 households (as average family size was 5 people according to the National Institute of Statistics).

Study clusters can consist of one or more villages or neighbourhoods that add up to the cluster size, or be a subdivision (comprising around 1075 people) of a larger neighbourhood or village .

The communities were randomly selected from a comprehensive list of villages and neighbourhoods that fulfilled the inclusion criteria in each of the communes.

Eligibility criteria

Inclusion criteria

For municipalities

Be considered as one of the municipalities prioritized by the FRESAN program;
Have a multidimensional poverty level of 4 or 5 according to the Angola National Statistical Institute classification;
Acceptance by local and traditional authorities.

For communes

Do not have community nutritional interventions in place or forecasted at the time of inclusion.

For communities [Villages (aldeias) and neighbourhoods (bairros)]

Do not have other interventions of monetary or nutritional transfers (specific or sensitive) in place or forecasted at the time of the inclusion in this study;
Acceptance by local authorities through the informed consent form signed by the community leader;
Place accessible by a 4x4 vehicle (especially during the rainy season);
Have a reference health post with reference health personnel.

For participants

Women 16 years and above;
Pregnancy confirmed by pregnancy test;
Acceptance to participate in the study through the free and informed consent form signed by the community leader and confirmed by the potential participants;
Live new borns of the participant pregnant women;

Exclusion criteria

For participants

Women 16 years of age or above, pregnant, who do not belong to pre-selected neighbourhoods/villages;
Women who don´t live in the household in a regularly manner;
Women who have planned to travel or move out of the neighbourhood within the follow-up period of the study;
Women who express the impossibility of attending the follow-up visits;
Women with a history of alcohol abuse (considered as intake of >3 drinks on any day or >7 drinks per week);
Any condition that may affect the intervention/follow-up compliance (at the discretion of the investigator);
Pregnant women with acute malnutrition (arm circumference < 21 cm).

The interventions

The standard of care intervention is provided at cluster level, the cash transfer, and nutrition supplements interventions at the individual level.

Standard of care arm (STANDARD Arm):

The new national policy for community development of the Ministry of Territorial Administration of the Republic of Angola foresees the implementation of a standard of care program to be delivered by a new figure, the ADECOS (Agentes de Desenvolvimento Comunitário e Sanitário) through the Institute of Local Development-Social Support Fund (FAS), included in the Health Community Workers classification. The ADECOS emerged as one of the strategies with more potential to address cost-effectively the scarcity of health human resources in remote areas, as they should be able to provide culturally competent services to improve accessibility to primary health care and community awareness in water, hygiene and sanitation (WASH) , nutrition, and health related good practices.

This policy is in different implementation phases across the country by the Government of Angola, but the Southern provinces have not yet started its implementation at the health care level. Thus, in the study areas of the provinces of Huila and Cunene, the Crescer project financed its implementation through the FAS, one of the partners of the Crescer consortium. This intervention will be used as a comparator as it fulfils the criteria of acceptability, feasibility, relevance and uniformity required to be a good comparator in this type of studies (19).

The activities to be developed by the ADECOS can be summarized in two types:

Health promotion activities: including community activities to promote adequate management of malnutrition and promotion of appropriate caring and feeding practices, and sensitization sessions to promote adequate hygiene and sanitation.

Preventive pharmacological activities: including malaria prophylaxis in pregnant women, deworming in pregnant women and children between 12 and 59 months, and vitamin A supplementation in children 6 to 24 months of age.

Standard of care + Nutritional supplementation (STANDARD + NUT Arm): Communities allocated to this arm receive the Standard of care intervention plus a nutritional supplementation to families with at least one pregnant woman. Nutritional supplementation consists of a daily intake of small quantity lipid based nutrients supplement (SQ-LNS) for the pregnant women and their new born children and a complementary food ration for their families, as described below.

Individual ration of SQ-LNS: for pregnant and lactating women until their new-born turns 6 months and for the new born children after their 6^th month and until the child turns 24 months of age (1 sachet) / day).
Complementary family food ration: basket of locally produced staple foods that complement the usual diet (300 Kcal/person/day). The caloric distribution of the basket will be 45% of cereals (corn meal - carbohydrate), 30% of legumes (beans - vegetable protein) and 25% of oil (soybean oil - fat). In addition, 1 kg of iodized salt will be provided.

Standard of care + Cash transfer (STANDADR + CT Arm): communities allocated to this arm will receive the Standard of care intervention and an unconditional cash transfer to families with at least one pregnant woman as described below. The pregnant woman, as the main participant, is defined as the cash transfer recipient.

A total of 13855 kwanzas per month is delivered to agregados familiares with four or more members living in the household during the study period, and 10855 kwanzas per month to families with less than four members living in the household during the period of study. The amount is delivered in cash with unconditional format.

Outcome measures

The outcomes are measured at individual level, but analysis and interpretation will be made at both cluster and individual levels.

Primary outcome

Mean height for age z score (HAZ) and proportion of children with moderate and severe chronic malnutrition (HAZ< -2 and <-3 z scores below the reference median) at 24 months of age

Secondary outcomes

Mortality rate at 3, 6, 12, 18 and 24 months after enrolment in the study. Mortality will be assessed during all study at selected time frames.
Proportion of neonatal low birth weight, and low birth weight for gestational age
Proportion of children with anaemia (Hb<12g/dL)
Cumulative incidence of morbidity (mainly malaria, diarrhoea and pneumonia) in children below 2 years of age
Primary household caregiver’s knowledge, attitudes and practices related to perinatal and children’s caring practices including breastfeeding and hygiene and sanitation
Women and children minimum dietary diversity

Measurements

Data collection tools

Questionnaires

At baseline and end line, we use self-elaborated questionnaires to collect general information of the household, as well as specific information of the head of the household, the primary household caregiver and the participant pregnant women. Sections in these questionnaires include: sociodemographic data, household assets, food security, knowledge, attitudes and practices related to children’s caring practices as well as hygiene, and sanitation, women’s empowerment, dietary diversity at household, women and children’s level, perinatal care and pregnant women’s morbidity and mental health.

In the follow up visits, data will be collected from study participants with specific self-elaborated questionnaires (mothers and children’s questionnaires).

Original questionnaires are in Portuguese and translation to local languages was conducted during the training with enumerators.

The questionnaires are in digital format, designed with the Ennov Clinical Software, and data is collected with the application Ennov Clinical through smart devices run on apple-based platforms. Data is sent to the data management centre every few days upon internet coverage availability.

Anthropometry

Arm circumference is measured in pregnant women and children using standard MUAC bracelets.

During the survey, women identified with a MUAC below 210 mm are referred to the nearest health facility for standard treatment. Children identified with a MUAC<125 mm are referred to the nearest out-patient therapeutic centre.

Body weight (kg) and height (cm) are measured in children. Weights are measured using the ADE M321600 electronic floor scale with mother and child weighing function.

Height is measured in children (standing or recumbent) using a wooden board suitable for measuring the length of infants and the height of children up to 160 cm.

Biochemical measures

Women identified as pregnant in the community are tested with the DIAGNOS© hCG one-step pregnancy tests to confirm their pregnancy status. If a negative result is obtained the test is repeated, and if a negative result is again obtained, the woman is referred to the health centre for follow up and she is excluded from the study.

Haemoglobin is measured using the Very-Q RED haemoglobin monitoring system (0.1 g/dl accuracy) in the participant women during visits where she is pregnant and in participant new born children at age 6 months, 12 months, 18 months and 24 months. If any participant is identified with an Hb<5 g/dl is referred to the nearest public health facility.

Malaria infection is measured with Abbot Malaria Ag P.f/Pan rapid test in children at 6, 12, 18 and 24 months of age. Children identified with a positive result are referred to the nearest health facility for standard treatment.

Data collection team

There are 12 teams of enumerators supervised by three research investigators and three field supervisors. Each team is composed by one medical or nursing student and one ADECOS and both received previous training for conducting the interviews and entering the data. Enumerators and supervisors were also trained in anthropometric and biochemical measurements according to international recommendations.

Pilot studies were conducted as part of the field work training and to test the tools in both Huila and Cunene provinces.

Data collection timeline

The recruitment and baseline survey has started in 10 October 2022 and will continue in February 2023. The research team makes field visits every 3 months in order to collect baseline measurements on all study households (household questionnaire) and participants (pregnant women), and follow up data on participants (mother and child questionnaires) until the new born child turns 2 years of age (end line survey). Thus, the end line surveys will be conducted at different times, depending on the date and the gestational age of the women at the time of recruitment, with dates for end line surveys ranging between November 2024 and February 2025.

The SQ-LNS Supplementation and the unconditional cash transfers are implemented during the quarterly visits. See Table 1.

Table 1: Data collection and interventions time line

Depending on the gestational age of the pregnant women and the age of the child at the time of the visit different data will be collected. Women will complete one or two questionnaires during pregnancy (around 6^th month of pregnancy and/or around 9^th month of pregnancy). In addition, once the children are born, all women and new born children included in the study will be surveyed (mother and child questionnaires) around 3 months, 6 months, 12 months, 18 months and 24 months of age of the children. Outcomes to be collected at those time points are detailed in Table 2.

Table 2: Data collected and time points according to the women’s gestational age and new born children’s age

Sample size

We used the results from the most recent SMART survey (18) to determine the chronic malnutrition prevalences for the sampling computations. In Huila, stunting prevalence was 50% and in Cunene 37%. We assumed an expected effect of the standard of care intervention to reduce chronic malnutrition by 13%, while all other strategies to reduce it by 18%.

We have assumed an intracluster correlation coefficient (ICC) of 0.006, and computed the design effect and inflation factor as follows:

Inflation factor = 1 + [(m – 1) x ICC]

where m is the size of the participants to be included in each cluster thus,

Inflation factor=1 + [(40 – 1) x 0.006]= 1 + [39x0.006]=1 + 0,234=1.234

The 15% was added as expected follow-up loss rate (estimated based on perinatal mortality, 50.2 per 1000 live births, according to World Bank data^{^[2]}).

The study was conceived as a community trial, controlled, open, non-inferiority, randomized by clusters.

Thus, in order to detect a 10% difference between the outcomes (stunting prevalence) in the non-inferiority margin, with a 80% power, it is necessary to recruit 6 clusters per arm with a fixed number of 40 pregnant women participants by cluster, distributed as described in Table 3 and Figure 2.

Table 3: Participants distribution by province

Intervention	Huíla	Cunene	Total
Standard of care (SoC)	6*40= 240	6*40= 240	480
SoC + Nutritional supplementation	6*40= 240	6*40= 240	480
SoC + Cash transfer	6*40= 240	6*40= 240	480
Total	720	720	1440

Recruitment

The recruitment of the communities is done by sensitisation sessions with the local authorities to whom the study design and planned interventions are explained in detail.

The local authorities (named Sobas and Seculos in Angola) sign an informed consent to allow for the participation of their communities in the study.

The week before the first field visit, local ADECOS conduct an active search to identify the pregnant women in the community. They visit the households to inform and sensitise all members of the family as well as pregnant women about the study to take place and the need of their participation in the upcoming survey visit. If ADECOS feel reluctance or uneasiness in the household about being part of the study, they approach the community leader and request his mediation to sensitise the family to the objectives of the study.

Random allocation

Allocation of interventions was done at cluster level. After signing the informed consent the community leaders had to take a slip of folded paper from a lottery ballot box where the intervention to be implemented in their communities was written. This way allocation concealment was guaranteed. In each commune, three clusters were allocated to each of the intervention arms.

The allocation of participants was done by complete enumeration. Up to 40 women living in the selected cluster are recruited by order of identification by the ADECOS in the previous weeks, and will receive the intervention allocated to their cluster. Women were requested informed consent to participate in the study after informing them of the study and the arm of the study they had been allocated.

Planned statistical methods

The analysis will be done at both cluster and individual level. Descriptive analyses will be carried out in all independent variables at cluster and individual level to characterize groups at baseline and identify potential differences between them.

Categorical variables will be presented as frequencies and percentages and continuous variables as medians (interquartile range) or means (standard deviation) according to data distribution.

Distribution normality will be checked by means of histograms and the Kolmogorov-Smirnov test.

The chi-square test or Fisher's exact test will be performed to compare frequencies between categorical variables and the Mann-Whitney test or Student's t-test will be used to compare continuous variables.

For the analysis of effectiveness, the comparison of the proportion of participants with chronic malnutrition between the clusters will be performed through generalized linear models with log-link and binomial distribution. We will estimate the value of the difference between the experimental interventions (STANDARD + NUT, STANDARD + TM arms) and the comparator intervention (STANDARD arm).

For the individual analysis, we will use longitudinal generalised mixed models.

We will do the analyses in two study populations. The first one, defined per intention to treat (ITT), comprises all randomized participants including those that did not fulfil the inclusion criteria but were randomized, those with an early withdrawal before starting the interventions and those facing major protocol deviations, all of which are considered treatment failures. The second one, obtained per protocol (PP), is the subset of participants belonging to the ITT who do not deviate from the protocol. Thus, it excludes participants facing any deviation from the protocol (do not comply with the instructions of the interventions or interrupt or permanently modify the proposed scheme).

Significance will be set at p<0.05 level.

[1] Municipio da Jamba. Distribuição da população por area sanitaria/2021.

[2] Mortality rate, infant (per 1,000 live births) - Angola | Data [Internet]. [citado 9 de julio de 2021]. Disponible en: https://data.worldbank.org/indicator/SP.DYN.IMRT.IN?locations=

The complex and multi-causal nature of chronic malnutrition makes especially challenging the endeavour of its prevention and reduction. The range of potential interventions and the financial constraints to implement them all, results in decision takers and policy makers facing the difficult task of choosing one strategy over others. The justification of these selections should be based on impact and sustainability of the interventions at hand.

Thus, generating high-level evidence on the effectiveness of different type of interventions on the prevention of chronic malnutrition, and understanding the pathways by which they operate can contribute to the uptake of better-informed decisions, and better design of future strategies.

The difficulties of implementing randomized control trials to test the effectiveness of public health interventions are well known, and mainly relate to the feasibility and ethics during implementation and the complexity of assuring internal and external validity of results obtained.

The Crescer consortium dedicated eighteen months to the preparation of the MuCCUA study. Only remote and difficult to access communities fulfilled inclusion criteria of having no intervention in place so many field trips were necessary to locate the communities, and it was necessary to elaborate timely maps for future visits, as there were no roads or maps to access them. Selected communities were visited several times to conduct sensitisation sessions about the project, obtain informed consent from community leaders and recruit the community agents (ADECOS) to implement the standard of care programme. Having the Angolan Fundo de Apoio Social as partner in the consortium make the recruitment of communities feasible, as they have a long history of community work in the study area.

In relation to the ethical concerns that may arise when implementing RCTs for public health interventions evaluation, the Crescer project assures that an improved standard of care programme is in place in all communities participating in the MuCCUA study, thus providing an overall benefit to all.

In order to preserve as much as possible the internal validity of results, the project collects comprehensive information on baseline characteristics of the interventions and control arms groups during the recruitment and baseline survey. Although external validity is difficult to ensure as context specificities play an important role in the degree of effectiveness obtained, understanding the pathways by which the different interventions effect stunting may provide a starting point framework for evaluating similar interventions in different contexts.

Moreover, one important strength is that the study is targeted to pregnant women and their new borns, and consequently, we expect to obtain valuable information on the impact of the different strategies on stunting prevention when targeting the 1000 days, starting during the pregnancy period.

Furthermore, at the time the study was designed the situation of food and nutrition insecurity in South Angola was not as severe as it is now. Nevertheless, this new scenario will give us the opportunity to assess how severe food insecurity and acute malnutrition interact with stunting progression and the impact of a long run project with a chronic malnutrition objective within humanitarian crises as the one lived today in these regions of Angola.

Collaborating organisations

The MuCCUA study is implemented by the Crescer consortium consisting of five partners and coordinated by the Hospital Universitari Vall d’Hebron Research Institute (VHIR). The four remaining partners are Universidade Mandume Ya Ndemufayo and Fundo de Apoio Social from Angola, and Instituto de Salud Carlos III and Action Against Hunger from Spain.

Ethics approval and consent to participate

The research protocol was approved on August 18^th, 2022 by the National Ethics Committee of República de Angola Ministério da Saúde, reference number 27C.E/MINSA.INIS/2022, and all methods are performed in accordance with the Helsinki Declaration. The trial was registered in clinical trials in October 7^th 2022, NCT05571280.

In order for the selected communities to participate in the study, the local authorities had to give written informed consent. Informative sessions were held with local authorities of communities selected in order to seek for their signed consent.

Before recruitment, informed consent is also sought from individual participants. Field teams inform of the project and the specific intervention allocated to the cluster they belong to before asking for consent. Pregnant women consent for their own participation and for their potential new born children’s. Women are informed that participation in the study is voluntary and that they can drop out at any time without giving explanations. Confidentiality is guaranteed during the study, as participants will receive a study code that will not allow their identification.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the project coordinator on reasonable request.

Data monitoring and auditing

Monitors will conduct regular monitoring visits, during which they will inspect and verify the source data of Informed Consent Forms, medical records, laboratory results, and protocol deviations .

Monitoring visits will be made periodically by VHIR representatives or designated monitors to ensure compliance with Good Clinical Practice (GCP) and all aspects of the protocol. Source documents will be reviewed for consistency with data in the electronic Case Report Forms (CRFs) and any data clarification forms/consultations.

Competing interests

No competing interests
Funding

The Crescer project is funded by the UE EuropeAid contract nº FED/2020/418-106 and co-financed by the Crescer consortium partners.

Authors’ contributions

EC contributed substantially to the conception and design of the trial protocol and to the drafting of the manuscript. ZH contributed substantially to the conception and design of the trial protocol and to the drafting of the manuscript. ET, MRB, FR, IA, EI, ASG, MLF, RMC, TM, AV, AG and IM contributed substantially to the conception and design of the trial protocol. All authors read and approved the final manuscript.

Acknowledgements

We would like to acknowledge the Crescer consortium and the MuCCUA study participants and field teams, local and provincial authorities, supervisors, students and ADECOS.

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No competing interests reported.

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