Nutritional Supplement Adherence among Women of Reproductive age Participating in a Randomized Controlled Trial in Northern Vietnam.

Objectives: Identify factors that influence adherence to consumption of micronutrient supplements before and during pregnancy among participants of a double-blind randomized controlled trial (PRECONCEPT) assessing the impact of weekly preconceptional multiple micronutrient supplements on maternal and child health outcomes in 20 rural communes in northern Vietnam. Methods: In-depth interviews were conducted with PRECONCEPT participants, including 15 prepregnant women receiving weekly micronutrient supplements, 8 pregnant women receiving daily iron-folate supplements, 8 women who had delivered and 8 drop-outs. Domains of interest included participants' experiences with supplements and knowledge about nutritional needs, micronutrient deficiencies, and the study. Four focus groups (one per participating district) were also conducted with Village Health Workers who distributed the supplements. Data were transcribed, translated, and coded and analyzed using MAXQDA software, applying the principles of grounded theory. Results: Knowledge about iron's value for maternal health was more widespread compared to other micronutrients. The importance of ensuring adequate "nutrient" levels during pregnancy for proper fetal development was also recognized, but supplements were considered as curative rather than preventive for maternal health. Functional support, positive reinforcement from health workers and family members, and perceived health benefits for mother and child were associated with improved adherence to supplement consumption, whereas misinformation and poor management of side effects may be associated with reduced adherence. Conclusions: Programs that distribute micronutrient supplements should include counseling materials that emphasize the preventive value of supplements for maternal health. Additional efforts that incorporate strategies to improve social support will also help improve community trust, increase adherence, and reduce dropout rates.

A Formative Research Study to Integrate Home Fortification of Complementary Foods into a Family Health Program in Bihar: Process and Methodology.

Objectives: The objective of this formative research was to develop a locally appropriate home fortification program for children (6-24mo) and to explore feasibility and acceptability within an integrated family health program in Bihar. Methods: The study consisted of three phases over a six month period. In Phase 1, we tested the acceptability of multiple micronutrient powders and developed contextualized packaging and counseling materials integrated with existing complementary feeding messages. We used focus group discussions (FGD, n=11) with frontline workers (FLWs), community members, mothers, mothers-in-law, and fathers to obtain feedback on product and supportive tools. In Phase 2, we explored community acceptability in 27 households (HHs) with children 6-24mo using a Trials of Improved Practices methodology. In-depth interviews (IDI) were held with HHs at baseline, midline and endline (day 10). Phase 3 was designed to evaluate the implementation process using existing program delivery platforms with FLWS in 3 health sub-centers (HSC). FLWs were trained to distribute products and counsel HHs on home fortification and complementary feeding. 5 FGDs and 3 IDIs were held with FLWs in addition to monthly HH monitoring data (n=20/HSC). Results: As a result of this formative work, counseling materials, FLW trainings and delivery approach were substantially revised to better reflect local context and program realities. Preliminary data suggest home fortification is well-accepted by community members and FLWs are willing to incorporate into existing work activities. Conclusions: This formative research methodology was vital for developing an integrated and locally acceptable home fortification program and informing future scale-up activities.

An Implementation Study to Assess a Health Worker-based Platform for a Home Fortification Program in Bihar.

Objectives: The main objectives of the study were to explore the feasibility of using Frontline health Workers (FLW) as a platform to deliver Multiple Micronutrient Powders (MMP) to the target population (children of 6-18 months) and to assess the acceptability of MMP among the community. This work was part of a multi-phase formative research study for contextualizing a home fortification strategy in Bihar. Methods: The program was implemented in three Health Sub Centers (HSCs) in West Champaran over a two-month duration. Key programmatic activities included FLW training for MMP distribution and counseling on complementary feeding; and community sensitization events to increase MMP acceptability. We conducted 5 focus group discussions and 3 in-depth interviews with FLWs along with monthly monitoring at the household level (n=20/HSC) to assess the program implementation. Results: Important implementation findings emerged through the soft roll-out. Firstly, the HSC meetings were found to be suitable as a FLW training platform but not for MMP distribution to FLWs due to logistical constraints. Secondly, the counseling brochures and community sensitization meetings were perceived to be important facilitators for MMP uptake by the community. Thirdly, FLWs reported positive levels of engagement, low perceptions of work burden and adopted diverse strategies for program delivery. Lastly, community uptake was found to be positive and primary barriers to compliance were mainly associated with supply issues rather than user preferences. Conclusions: The implementation study proved to be a valuable step in identifying critical operational and programmatic factors to inform future large-scale program activities.

Compliance to micronutrient supplementation in children 3 to 24 months of age from a semi-rural community in Mexico

OBJECTIVE: To identify associated factors to compliance for multiple micronutrient (MM) or iron and vitamin A (IVITA) supplementation, in children (3 to 24 months old). MATERIALS AND METHODS: A database (n=465 children) from a randomized, controlled, clinical trial, carried out in a semi-rural setting in Mexico, was analyzed. The compliance rate of MM and IVITA supplements was calculated. Adequate compliance rate (AC>80%), and its association with children and households characteristics, was determined. RESULTS: The compliance mean was high (MM:78.2%, IVITA:80.1%; p<0.05). The odds of AC were 59% greater in the children of IVITA than with MM group, although the estimate was only marginally significant (p=0.052). Maternal education (p<0.001), child birth weight (p=0.003), and children with cough (p<0.001) or fever (p=0.024) were significantly associated with AC and significantly marginal was maternal indigenous (p=0.071). CONCLUSION: The high AC was consistent with others efficacy studies. More research is needed to document physiological, cultural, social and operative factors affecting compliance with supplementation.

OBJETIVO: Identificar factores asociados con el cumplimiento del consumo de suplementos con micronutrimentos múltiples (MM) o con hierro y vitamina A (FEVITA) en niños (<24 meses de edad). MATERIAL Y MÉTODOS: Información de un ensayo clínico aleatorizado, doble ciego en una localidad semirrural en México. Se calculó el porcentaje de cumplimiento (n=465 niños), cumplimiento adecuado (CA: >80%) y su asociación con varias características. RESULTADOS: El cumplimiento fue alto (MM: 78.2%, FEVITA: 80.1%; p<0.05). Los momios de CA fueron 59% mayores en niños del grupo FEVITA que en MM (p=0.052). Escolaridad materna (p<0.001), peso al nacer del niño (p=0.003), porcentaje de tiempo con tos (p<0.001) y con fiebre (p=0.024) y marginalmente, la condición indígena materna (p=0.071) se asociaron con el CA. CONCLUSIONES: La alta tasa de cumplimiento fue consistente con otros estudios. Es necesaria mayor investigación sobre factores fisiológicos, culturales, sociales y operativos relacionados con el cumplimiento del consumo de suplementos.

Prenatal multiple micronutrient supplementation impact on biochemical indicators during pregnancy and postpartum / Efecto de la suplementación prenatal con micronutrimentos múltiples en indicadores bioquímicos durante el embarazo y el posparto

Objective. The objective of this analysis was to test the impact of daily supplementation with multiple micronutrients (MM) during pregnancy on Zn, vitamin A and folate status compared to iron only (Fe). Material and Methods. The study was carried out during 1997-2000 in a semi-urban community in Morelos state, Mexico. Women were randomly assigned to MM (n= 249) or Fe (n= 258) and received supplements daily (6 d/wk) under supervision by the field team from recruitment (approximately 9 weeks pregnancy) until delivery. Blood samples were collected on a sub-sample of women at baseline, 32 weeks pregnancy and one month postpartum (1PP) and assessed for serum zinc, retinol and whole blood folate (baseline and 1PP only). A breast milk sample was extracted at 1PP and assessed for retinol content. Result. At baseline there was no significant difference between supplementation groups in mean Zn, retinol or folate concentrations or the prevalence of deficiencies (Zn 12.2%, vitamin A 2.8%, folate 5.3%). Mean change in Zn and retinol concentrations from baseline to 32 weeks pregnancy did not differ between groups or between baseline and 1PP for Zn, retinol or folate. At 1PP, there was a tendency (p= 0.09) towards a lower prevalence of folate deficiency/depletion in the MM group (10.0%) than the Fe group (18.5%). Conclusions. MM supplementation during pregnancy did not improve zinc or vitamin A status compared to Fe only. There is some indication that folate status may have improved with MM supplementation despite low prevalence of deficiency. While lack of response in serum retinol may be explained by generally adequate status, the lack of impact on zinc status requires further exploration.

Objetivo. Evaluar el efecto de la suplementación diaria con múltiples micronutrimentos (MM) durante el embarazo en el estado de zinc, vitamina A y folato comparado con la suplementación sólo con hierro (Fe). Material y métodos. El estudio se realizó en una comunidad semiurbana en el estado de Morelos, México, entre 1997 y 2000. Las mujeres fueron asignadas aleatoriamente a recibir un suplemento de MM (n= 249) o Fe (n= 258) diariamente (6 días/semana), cuyo consumo fue supervisado por personal de campo, desde la evaluación basal (aproximadamente 9 semanas de gestación) hasta el parto. En una submuestra de mujeres participantes, se tomaron muestras de sangre venosa, a las 9 y 32 semanas de embarazo y al mes posparto (1PP). Se midieron las concentraciones séricas de zinc y retinol y la concentración de folato en sangre total, esta última sólo en la evaluación basal y al 1PP. Además se colectó una muestra de leche materna al 1PP, en donde se midió la concentración de retinol. Resultados. En la evaluación basal no hubo diferencias significativas entre grupos en las concentraciones promedio de zinc y retinol, ni en la concentración de folato o en la prevalencia de deficiencias (Zn 12.2%, vitamina A 2.8%, folato 5.3%). El cambio promedio en zinc y retinol de la evaluación basal a la semana 32 de embarazo, no fue diferente entre grupos, tampoco entre la evaluación basal y al 1PP en zinc, retinol o folato. Al 1PP hubo una tendencia (p= 0.09) a menor prevalencia de deficiencia/depleción de folato en el grupo de MM (10.0%) que en el grupo Fe (18.5%). Conclusiones. La suplementación con MM durante el embarazo no mejoró el estado de zinc y vitamina A comparada con la suplementación sólo con Fe. Sin embargo, el estado de folato puede haber mejorado con la suplementación con MM, a pesar de la baja prevalencia de deficiencia de folato. La falta de efecto...

Multiple micronutrient supplementation and dietary energy intake in pregnant women

OBJECTIVE: To compare dietary intake of women supplemented with multiple micronutrients (MM) or iron only during pregnancy. MATERIALS AND METHODS: Design: Randomized, double-blind, controlled community-based trial. Setting: One semi-urban community in Central Mexico. Subjects: Pregnant women identified before week 13 of pregnancy, willing to provide informed consent. Interventions: Women were randomly assigned to receive daily supplementation with MM or iron only from recruitment until delivery. Supplements were delivered to the participants' home and compliance observed daily. Dietary intake was assessed by repeat 24-hr recall. Data were analyzed using non-parametric tests and multiple regression analysis to determine the impact of MM supplementation on dietary intake of energy and select micronutrients. RESULTS: During the third trimester, women in the MM group consumed more energy and iron from dietary sources than women in the iron only group. After adjustment for differences between the groups at baseline, women in the MM group consumed 111.3 kcal/day more (p<0.05) energy. The difference in iron intake was not significant after adjusting for the increase in energy intake. CONCLUSIONS: Women consuming MM supplements during pregnancy increased energy intake from dietary sources without a concurrent increase in micronutrient density. Future studies should include measures of appetite and physical activity during pregnancy to determine the implications of additional energy intake for weight gain and retention.

OBJETIVO: Comparar la dieta de mujeres suplementada con múltiples micronutrimentos (MM) o sólo con hierro durante el embarazo. MATERIAL Y MÉTODOS: Diseño: ensayo comunitario, aleatorizado, controlado, doble ciego. Lugar: una comunidad semiurbana en el México central. Participantes: mujeres embarazadas identificadas antes de la semana 13 de embarazo, dispuestas a entregar el consentimiento informado. Actividades: las mujeres fueron asignadas en forma aleatoria a recibir suplementación diaria con MM o exclusivamente hierro desde el reclutamiento hasta el parto. Los suplementos se entregaron en la casa de las participantes y se observó su cumplimiento con frecuencia diaria. El consumo dietético fue valorado por mediciones repetidas de recordatorio de alimentos de 24 h. Los datos se analizaron mediante pruebas no paramétricas y análisis de regresión múltiple, para determinar el impacto de la suplementación MM en el consumo dietético de energía y micronutrimentos seleccionados. RESULTADOS: durante el tercer trimestre, la mujer asignada al grupo MM consumió más energía y hierro de fuentes dietéticas que la mujer asignada al grupo de sólo hierro. Después de los ajustes para las diferencias entre grupos en la línea basal, la mujer del grupo MM consumió 111.3 kcal/día más (p< 0.05) de energía. La diferencia en el consumo de hierro no fue significante después de los ajustes para el incremento en el consumo de energía. CONCLUSIONES: la mujer que consume suplementos MM durante el embarazo aumenta el consumo de energía a partir de fuentes dietéticas sin un incremento concurrente en la densidad de micronutrimentos. Estudios futuros deberían incluir mediciones del apetito y de la actividad física durante el embarazo para determinar las consecuencias del consumo de energía adicional en la ganancia de peso y la retención.