Program Impact Pathways and Contexts: A Commentary on Theoretical Issues and Research Applications to Support the EsIAN Component of Mexico's Conditional Cash Transfer Program.

This commentary on the Integrated Strategy for Attention to Nutrition (EsIAN) journal supplement begins with a discussion about the challenges that implementation researchers confront with respect to analyzing complex impact pathways. We note that the research on the implementation of the EsIAN component of Mexico's conditional cash transfer program was based implicitly or explicitly on a program impact pathway approach, which used both quantitative and qualitative methods to examine bottlenecks in program implementation. We then identify 5 categories of contexts that affect the impact, implementation, and survival of intervention programs: 1) biological, 2) social-cultural, 3) delivery modalities and platforms, 4) bureaucratic, and 5) political. Each of these contexts presents theoretical and methodological challenges for investigators. In this commentary, we focus primarily on biological and social-cultural contexts, discussing the theoretical and methodological challenges the investigators faced and the research strategies they used to address them, which have produced a unique compilation of "learning by doing" studies. We also touch briefly on the political context in which the Prospera program research was conducted. We conclude with statements that highlight the exceptional value of the journal supplement, not only with respect to the analysis of the interventions the studies cover and the sustained examination of a long-term program but also as a major contribution to the literature in implementation science in nutrition.

Sociocultural Influences on Poor Nutrition and Program Utilization of Mexico's Conditional Cash Transfer Program.

BACKGROUND: The impact of the Conditional Cash Transfer Program in Mexico was significant but smaller than expected. Several bottlenecks related to program design and implementation have been identified that may have limited its impact; population and other contextual factors may be equally important to analyze. OBJECTIVES: We aimed to explore how sociocultural context contributes to poor nutrition in Mexico and how it shaped the acceptability, fidelity, and penetration of the fortified food and of education sessions provided by the program. METHODS: We carried out qualitative research studies in the central and southern states in urban, rural, and indigenous settings between 2001 and 2014 with different informants and by using interviews, focus group discussions, and nonparticipatory observation. We explored 4 dimensions of the sociocultural context: objective dimension (e.g., food availability and family organization), social norms and symbolic meaning related to child feeding, literacy and communication with the biomedical culture, and knowledge related to child care generally and child feeding. We generated information about the experience of the beneficiaries with fortified food and education sessions. RESULTS: Several sociocultural factors, including patriarchal family organization, high availability of nonnutritious food, social norms promoting the consumption of food in liquid form for young children, sharing of food among family members, traditional knowledge, and communication barriers with the biomedical culture, participated in shaping the poor nutrition situation, the inadequate utilization of fortified foods, and the inappropriateness of the education sessions. CONCLUSIONS: Our studies revealed the importance of local context and culture to understand the acceptance, utilization, and impact of a nutrition program and shed light on infant and child feeding practices. This knowledge is critical to strengthen program designs and ensure adequacy with the diversity of cultural and social contexts in which programs are implemented.

Mixed methods evaluation explains bypassing of vouchers in micronutrient powder trial in Mozambique.

Micronutrient powders (MNP) are recommended by the World Health Organization as an effective intervention to address anaemia in children. A formative process evaluation was conducted to assess the viability of a model using free vouchers in two districts of Mozambique to deliver MNP and motivate adherence to recommendations regarding its use. The evaluation consisted of (a) an examination of programme outcomes using a cross-sectional survey among caregivers of children 6-23 months (n = 1,028) and (b) an ethnographic study to investigate delivery experiences and MNP use from caregiver perspectives (n = 59), programme managers (n = 17), and programme implementers (n = 168). Using a mixed methods approach allowed exploration of unexpected programme outcomes and triangulation of findings. The survey revealed that receiving a voucher was the main implementation bottleneck. Although few caregivers received vouchers (11.5%, CI [9.7, 13.6]), one-fourth received MNP by bypassing the voucher system (26.3%, CI [23.6, 29.0]). Caregivers' narratives indicated that caregivers were motivated to redeem vouchers but encountered obstacles, including not knowing where or how to redeem them or finding MNP were not available at the shop. Observing these challenges, many programme implementers redeemed vouchers and distributed MNP to caregivers. Virtually, all caregivers who received MNP reported ever feeding it to their child. This study's findings are consistent with other studies across a range of contexts suggesting that although programmes are generally effective in motivating initial use, more attention is required to improve access to MNP and support continued use.

Designing an ethnographic interview for evaluation of micronutrient powder trial: Challenges and opportunities for implementation science.

The evidence base for micronutrient powder (MNP) interventions predominantly consists of quantitative studies focused on measuring coverage, utilization, and/or biological outcomes. We need other types of studies to broaden the scope of our knowledge about determinants of MNP programme effectiveness. Addressing this knowledge gap, this paper focuses on the process of designing an ethnographic research protocol to obtain caregivers' perspectives on the factors that influenced their use of intervention delivery services and their adherence to MNP recommendations. The research was undertaken within the context of formative evaluations conducted in Mozambique and Ethiopia. Ethnography provides a means for acquiring and interpreting this knowledge and is an approach particularly well suited for formative evaluation to understand the response of a population to new interventions and programme delivery processes. We describe decisions made and challenges encountered in developing the protocol, and their implications for advancing methodology in implementation research science. In addition to a core team of three investigators, we added an "advisory group" of 10 experts to advise us as we developed the protocol. The advisory group reviewed multiple drafts of the interview protocol and participated in mock interviews. In the protocol development process, we faced the issues and made decisions about concerned gaps in content, cultural adaptations and comprehension, and interview guide structure and format. Differences between the core team and the advisory group in methodological approaches to the structure and content of questions call attention to the importance of establishing greater communication among implementation scientists working in nutrition interventions.

Bottlenecks and predictors of coverage and adherence outcomes for a micronutrient powder program in Ethiopia.

A theory-driven evaluation was conducted to assess performance of a trial to deliver micronutrient powder (MNP) through the Ethiopian Ministry of Health. We adapted an approach to coverage assessment, originally developed to identify bottlenecks in health service delivery, to examine sequential program outcomes and their correlates using cross-sectional survey data of caregivers of children 6-23 months (N = 1915). Separate multivariable Poisson regression models were used to estimate adjusted risk ratios of conceptually relevant determinants of coverage and adherence. Caregivers of children >11 months were more likely to have received MNP than caregivers of younger infants, yet children 12-17 months were 32% (P < 0.001) and children 18-23 months 38% (P < 0.001) less likely to have been fed MNP in the 14 days preceding the survey than children 6-11 months. Among caregivers who initiated feeding MNP, the most frequently reported reasons for discontinuing use were not obtaining additional supply (36.1%) and perceived child rejection of food with MNP (22.9%). For each additional time a caregiver met with frontline workers in the 3 months preceding the survey, they were 13% more likely to have recently fed MNP (P < 0.001). Caregivers' perception that MNP produced positive changes in children was associated with a 14% increase in the likelihood of having recently fed it (P < 0.001). These results emphasize the importance of counselling for MNP and infant and young child feeding for initial use and the importance of multiple contacts with frontline workers for continued use.

Ethiopian mothers' experiences with micronutrient powders: Perspectives from continuing and noncontinuing users.

As part of a formative evaluation of a micronutrient powder (MNP) trial in Ethiopia that was organized according to a programme impact pathway model, we conducted in-depth focused ethnographic interviews with caregivers of children between 6 and 23 months who had accepted to try "Desta," a locally branded MNP. After stratification into two subgroups by child age, respondents were randomly selected from lists of caregivers who had received MNP from government health workers between 1 and 3 months prior to the interview date. Thirty women who were either currently giving Desta to their child ("continuing users," n = 14) or had stopped feeding Desta ("noncontinuing users," n = 16) were purposefully recruited from both urban and rural areas in the two different regions where the trial was conducted. Interviews were recorded, transcribed and translated, and coded for both emerging and prespecified themes. On the basis of identifiable components in the caregiver adherence process, this paper focuses exclusively on factors that facilitated and inhibited "appropriate use" and "continued use." For "appropriate use," defined as the caregiver preparing and child consuming MNP as directed, we identified four common themes in caregiver narratives. With respect to "continued use," the caregiver providing and child consuming the minimum number of MNP sachets over a recommended time period, our interviews spontaneously elicited five themes. We also examined caregivers' perceptions related to problems in obtaining refills. Attention to caregivers' perspectives reflected in their narratives offers opportunities to improve MNP utilization in Ethiopia, with potential application in other social and cultural settings.

Integrating Calcium Supplementation into Facility-Based Antenatal Care Services in Western Kenya: A Qualitative Process Evaluation to Identify Implementation Barriers and Facilitators.

BACKGROUND: In countries with low calcium intake, the WHO recommends integrating calcium supplementation into antenatal care (ANC) to reduce the risk of preeclampsia, a leading cause of maternal mortality. Current WHO guidelines recommend women take 3-4 calcium supplements plus 1 iron-folic acid supplement at separate times daily. There is limited evidence about implementing these guidelines through routine ANC. Through the Micronutrient Initiative-Cornell University Calcium (MICa) trial, we examined the effect of regimen on supplement consumption among ANC clients in western Kenya. A nested process evaluation examined factors that influence calcium supplementation delivery and uptake. OBJECTIVES: This process evaluation assessed ANC providers', pregnant women's, and family members' experiences with calcium supplementation, and investigated the feasibility and acceptability of engaging family members to support adherence. METHODS: We conducted semistructured interviews with 7 ANC providers, 32 pregnant women, and 20 adherence partners (family members who provide reminders and support), and 200 observations of ANC consultations. Interviews were transcribed, translated, and analyzed thematically. Observational data were summarized. RESULTS: ANC providers reported positive feelings about calcium supplementation, the training received, and counseling materials, but reported increased workloads. Women reported that providers counseled them on supplement benefits and managing side effects, offered reminder strategies, and provided supplements and behavior change materials. Women explained that reminder materials and adherence partners improved adherence. Most adherence partners reported providing reminders and other instrumental support to help with pill taking, which women confirmed and appreciated. Some women reported that comorbidities, concerns about being perceived as HIV positive, pill burden, unfavorable organoleptic properties, and lack of food were adherence barriers. CONCLUSIONS: Although integrating calcium into antenatal iron-folic acid supplementation was generally acceptable to ANC providers, pregnant women, and their families, calcium supplementation presents unique challenges that must be considered to successfully implement these guidelines.This trial was registered at clinicaltrials.gov as NCT02238704.

Adherence-Specific Social Support Enhances Adherence to Calcium Supplementation Regimens among Pregnant Women.

Background: WHO guidelines recommend integrating calcium supplementation into antenatal care (ANC) alongside iron and folic acid (IFA) to reduce maternal mortality. However, supplementation programs face multiple barriers, and strategies to improve adherence are needed. An adherence partner is someone whom pregnant women ask to support adherence at home.Objectives: This study 1) assessed adherence partner acceptability, feasibility, and associations with calcium and IFA supplement adherence and 2) examined relations between social support and adherence.Methods: This secondary analysis is from a trial integrating calcium supplementation into ANC in Kenya. ANC providers were trained on calcium and IFA supplementation and counseling, provided with behavior change materials, and given adequate supplement supplies. Pregnant women from 16 government health facilities were recruited (n = 1036); sociodemographic and adherence data were collected at baseline and at 4- to 6-wk follow-up visits. Adherence was measured with pill counts and self-reports. Culturally adapted scales measured social support in general and specific to adherence. Mixed-effects regression analyses were used to examine factors associated with adherence partners, social support, and adherence.Results: Most participants received information about adherence partners (91%) and had a partner at follow-up (89%). Participants with adherence partners reported higher adherence support (OR: 2.10; 95% CI: 1.32, 3.34). Mean ± SD adherence was high for calcium (88.3% ± 20.7%) and IFA (86.1% ± 20.9%). Adherence support was positively associated with calcium adherence at follow-up by using pill counts (OR: 2.2; 95% CI: 1.1, 2.6) and self-report data (OR: 1.9; 95% CI: 1.2, 2.9), but there was not a direct relation between adherence partners and adherence.Conclusions: Adherence support enhanced adherence to calcium supplements. The adherence partner strategy was highly acceptable and feasible but warrants further study. This research demonstrates the importance of adherence support and suggests that interventions to increase household-level support for antenatal micronutrient supplementation may be needed to implement the WHO guidelines. This trial was registered at clinicaltrials.gov as NCT02238704.

Toward a Better Understanding of Adherence to Micronutrient Powders: Generating Theories to Guide Program Design and Evaluation Based on a Review of Published Results.

Background: The Global Alliance for Improved Nutrition is conducting theory-driven process evaluations of micronutrient powder (MNP) programs. Objective: The aim was to generate preliminary theories about factors affecting adherence to recommendations with regard to point-of-use fortification of foods with MNPs. Methods: A literature search was conducted to identify documents with content related to adherence to MNPs as an intervention provided at home to children 6-59 mo of age. Thirty-five studies and 6 program descriptions were identified. We used thematic analyses to generate a comprehensive list of factors that could influence adherence, followed by content analysis to quantify the results. We developed a Program Impact Pathway to concretize the points at which the factors identified affect the process of adherence. Results: In the set of documents reviewed (n = 41), the most influential factors, measured by number of documents reporting the factor having effect, were 1) caregivers' perception of positive changes as a result of MNP use (n = 14), 2) caregivers' perceived child acceptance of food with MNPs (n = 12), and 3) caregivers' forgetfulness (n = 11). Behavior change communication channels (n = 13) and messages (n = 12) were the most frequently reported program design features influencing caregiver knowledge and subsequent adherence. Administration regimen (n = 10), which may be related to caregivers' capacity to remember to give MNPs, was also a frequently cited program design feature affecting adherence. Conclusions: The preponderance of knowledge and perception factors may reflect an underlying theoretical bias among researchers as to what they measure. To achieve programs that support greater adherence, we need to adopt a cultural-ecological perspective to inform program design in order to address a broader set of determinants. Studies that assess progress across the impact pathway, particularly from adherence to biological outcomes, would also provide guidance for evaluation studies, particularly when time or other constraints limit the potential to measure biological outcomes.

Adherence partners are an acceptable behaviour change strategy to support calcium and iron-folic acid supplementation among pregnant women in Ethiopia and Kenya.

Antenatal calcium and iron-folic acid (IFA) supplementation can reduce maternal mortality and morbidity. Yet, even when pregnant women have a stable supply of supplements, forgetting is often a barrier to adherence. We assessed the acceptability of adherence partners to support calcium and IFA supplementation among pregnant women in Kenya and Ethiopia. Adherence partners are a behaviour change strategy to improve adherence, where pregnant women are counselled to select a partner (e.g. spouse, relative) to remind them to take their supplements. We conducted trials of improved practices, a formative research method that follows participants over time as they try a new behaviour. We provided pregnant women in Ethiopia (n = 50) and Kenya (n = 35) with calcium and IFA supplements and counselling, and suggested selecting an adherence partner. For each participant, we conducted semi-structured interviews about acceptability and adherence during four interviews over six weeks. We analysed interview transcripts thematically and tallied numerical data. In Kenya, 28 of 35 women agreed to try an adherence partner; almost all selected their husbands. In Ethiopia, 42 of 50 women agreed to try an adherence partner; half asked their husbands, others asked children or relatives. Most women who did not select adherence partners reported not needing help or not having anyone to ask. Participants reported adherence partners reminded and encouraged them, brought supplements, provided food and helped address side-effects. Almost all women with adherence partners would recommend this strategy to others. Adherence partners are an acceptable, low-cost strategy with the potential to support antenatal micronutrient supplementation adherence.

Using ethnography in implementation research to improve nutrition interventions in populations.

'Implementation research in nutrition' is an emerging area of study aimed at building evidence-based knowledge and sound theory to design and implement programs that will effectively deliver nutrition interventions. This paper describes some of the basic features of ethnography and illustrates its applications in components of the implementation process. We review the central purpose of ethnography, which is to obtain the emic view--the insider's perspective--and how ethnography has historically interfaced with nutrition. We present examples of ethnographic studies in relation to an analytic framework of the implementation process, situating them with respect to landscape analysis, formative research, process evaluation and impact evaluation. These examples, conducted in various parts of the world by different investigators, demonstrate how ethnography provided important, often essential, insights that influenced programming decisions or explained programme outcomes. Key messages Designing, implementing and evaluating interventions requires knowledge about the populations and communities in which interventions are situated, including knowledge from the 'emic' (insider's) perspective. Obtaining emic perspectives and analysing them in relation to cultural, economic and structural features of social organisation in societies is a central purpose of ethnography. Ethnography is an essential aspect of implementation research in nutrition, as it provides important insights for making decisions about appropriate interventions and delivery platforms; determining how best to fit aspects of programme design and implementation into different environmental and cultural contexts; opening the 'black box' in interventions to understand how delivery and utilisation processes affect programme outcomes or impacts; and understanding how programme impacts were achieved, or not.

The focused ethnographic study 'assessing the behavioral and local market environment for improving the diets of infants and young children 6 to 23 months old' and its use in three countries.

The concept of a focused ethnographic study (FES) emerged as a new methodology to answer specific sets of questions that are required by agencies, policymakers, programme planners or by project implementation teams in order to make decisions about future actions with respect to social, public health or nutrition interventions, and for public-private partnership activities. This paper describes the FES on complementary feeding that was commissioned by the Global Alliance for Improved Nutrition and highlights findings from studies conducted in three very different country contexts (Ghana, South Africa and Afghanistan) burdened by high levels of malnutrition in older infants and young children (IYC). The findings are analysed from the perspective of decision-making for future interventions. In Ghana, a primary finding was that in urban areas the fortified, but not instant cereal, which was being proposed, would not be an appropriate intervention, given the complex balancing of time, costs and health concerns of caregivers. In both urban and rural South Africa, home fortification products such as micronutrient powders and small quantity, lipid-based nutrient supplements (LNS) are potentially feasible interventions, and would require thoughtful behaviour change communication programmes to support their adoption. Among the important results for future decision-making for interventions in Afghanistan are the findings that there is little cultural recognition of the concept of special foods for infants, and that within households food procurement for IYC are in the hands of men, whereas food preparation and feeding are women's responsibilities.

Multiple micronutrient interventions are efficacious, but research on adequacy, plausibility, and implementation needs attention.

Evidence for the efficacy of multiple micronutrient (MMN) supplementation has been established by state-of-the-art randomized controlled trials (RCT). These efficacy trials have also provided strong evidence of the widespread occurrence of deficiencies. Trials intended to demonstrate a public health benefit must show that the magnitude of benefit is adequate for policy considerations. In the MMN efficacy studies the magnitude of impact was generally inadequate. The extent to which this was due to various factors that affect individuals' potential to respond to MMN supplementation has not been examined, and trials have not been designed to provide insights into why impact is below expectation. For instance, when birth weight was the outcome of concern, impact was not related to presumed need, judged by baseline birth-weight values. Also, contrary to expectations, the impacts were greater among the heavier mothers. Our inability to examine issues of adequacy, plausibility, and implementation with efficacy trial approaches as they are currently conducted, calls into question the present standards for designing and interpreting community RCT in nutrition. Improving the capacity of efficacy studies to yield more meaningful data requires a number of modifications to current practices, such as including measures of the intermediary behavioral and biological steps between intervention and biological outcomes to assess the adequacy and plausibility of the findings. The progression from RCT to program interventions must also extend research to program delivery and uptake to ascertain the full program impact pathway. This in turn requires novel organizations of relationships between research and program development and implementation.

Responsive feeding: implications for policy and program implementation.

In this article, we examine responsive feeding as a nutrition intervention, with an emphasis on the development and incorporation of responsive feeding into policies and programs over the last 2 decades and recommendations for increasing the effectiveness of responsive feeding interventions. A review of policy documents from international agencies and high-income countries reveals that responsive feeding has been incorporated into nutrition policies. Official guidelines from international agencies, nongovernmental organizations, and professional organizations often include best practice recommendations for responsive feeding. Four potential explanations are offered for the rapid development of policies related to responsive feeding that have occurred despite the relatively recent recognition that responsive feeding plays a critical role in child nutrition and growth and the paucity of effectiveness trials to determine strategies to promote responsive feeding. Looking to the future, 3 issues related to program implementation are highlighted: 1) improving intervention specificity relative to responsive feeding; 2) developing protocols that facilitate efficient adaptation of generic guidelines to national contexts and local conditions; and 3) development of program support materials, including training, monitoring, and operational evaluation.

Organoleptic properties, ease of use, and perceived health effects are determinants of acceptability of micronutrient supplements among poor Mexican women.

We assessed the acceptability of 3 micronutrient supplements for pregnant and lactating women: micronutrient powder (Sprinkles), a fortified food (Nutrivida), and tablets. Pregnant or lactating beneficiaries of the Oportunidades program participating in a cluster randomized supplementation trial in urban Mexico were surveyed about the acceptability of 1 of 3 supplements (n = 268). Semistructured interviews (n = 40) were also conducted with a subset of women in the trial and from adjacent rural areas. Acceptability of the supplements was evaluated based on women's perceptions and experiences with organoleptic qualities, ease of use, and perceived health effects (positive and negative). The median Likert scale ranking of organoleptic and use qualities for all 3 supplements was "I liked it" (2 on a scale of 1-5). However, responses to open-ended survey questions and semistructured interviews indicated decided preferences. Tablets and Sprinkles were strongly preferred over Nutrivida. In interviews, women expressed dislike of the smell, taste, and texture of Nutrivida; they found it cumbersome to store and prepare and reported the most negative effects with it. Between tablets and Sprinkles, tablets were preferred because of the absence of perceptible taste or smell and the simplicity of use. This study provides valuable insights into our currently limited understanding of women's perceptions and preferences among supplements by broadening the concept of acceptability beyond organoleptic properties. Such an analytical approach is useful for identifying both appropriate nutritional supplements within a given sociocultural context as well as the information that should be included in nutrition education to improve adherence.

Maternal knowledge and use of a micronutrient supplement was improved with a programmatically feasible intervention in Mexico.

In Mexico, the potential impact on child malnutrition from a nutritional supplement (papilla) delivered through a conditional transfer program (Oportunidades) was attenuated by problems of household utilization. A behavioral change through communication intervention was developed to improve supplement utilization. Our study assessed the efficacy of this intervention through the results of a randomized trial. In 2 states (Veracruz and Chiapas) 2 clusters of communities were randomly assigned to intervention or control groups. Data were obtained from 176-198 mothers in intervention and control communities using a survey questionnaire at preintervention baseline and at a 5-mo follow-up. Concordance between reported and observed behaviors was examined through an observational substudy. The 4 behavioral recommendations were: 1) prepare papilla as a pap; 2) administer the preparation every day; 3) administer it between breakfast and dinner; and 4) administer it only to target children. The intervention resulted in a significant increase (P<0.05) in the prevalence of reported correct behaviors in the intervention group compared with the control for 3 of the behaviors: a mean increase of 42.5% for preparing papilla as pap, 64.4% for daily administration, and 61.5% for giving papilla between breakfast and dinner. Administering to a target child increased significantly in Veracruz (from 51.5% to 90.6%), but not in Chiapas (20.6% to 33.3%). Reported behaviors agreed with observed behaviors in the substudy. With the exception of the target-child administration in Chiapas, adopting the recommendations was culturally acceptable and feasible. The results indicate that improvements in household utilization of the supplement can be achieved with a communication intervention that is potentially feasible for implementation on a large scale within the Oportunidades Program.

Coping with a nutrient deficiency: cultural models of vitamin A deficiency in northern Niger.

Cultural explanations and management strategies for specific signs and symptoms of vitamin A deficiency are explored in a Hausa-speaking community in northern Niger. Their interpretations of the etiology of nightblindness in young children and pregnant women focus on food-related causes, in which "lack of good food" is central. In parallel with the significance of food in the etiology of nightblindness, the recommended treatments are home food remedies, primarily involving liver, meat, or green leaves. The locally attributed etiology for the more severe manifestation of vitamin A deficiency, xerophthalmia, stands in sharp contrast to this. People believe the primary cause is "heat" produced by acute infectious disease (particularly measles). A trip to the medical dispensary or a reliance upon home remedies are the preferred treatment options for this condition. We explore the striking correspondence between local interpretations of nightblindness and contemporary medical knowledge and treatment in relation to the very different explanations and curative measures offered for more serious manifestations of vitamin A deficiency.