Background
Rationale and background for the study
Question 1: How do intensive counseling and/or nutritional supplementation affect linear growth faltering and child development?
Question 2: What is the optimal timing and composition of interventions to promote growth and child development?
Question 3: What is the most cost-effective way to promote growth and child development and is it scalable within the existing program structure?
Question 4: What are the synergies and complementarities of integrating nutrition and early stimulation home visits within a large scale program?
Objectives of the MAHAY study
Methods/Design
Overview of the design
Description of the interventions
Study arm | Intensive counseling on nutrition (IC) | IC + LNS for children 6–18 months | IC + LNS for pregnant & lactating women +LNS for children 6-18 months | IC + Early childhood stimulation and development |
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T0) N = 25 Communities | ||||
T1) N = 25 Communities | ✓ | |||
T2) N = 25 Communities | ✓ | ✓ | ||
T3) N = 25 Communities | ✓ | ✓ | ✓ | |
T4) N = 25 Communities | ✓ | ✓ |
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T0) (comparison) program as currently designed (“status quo”): community-based nutrition program with growth monitoring and education.
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T1) Intensive counseling: the existing community-based program enhanced with preventive home visits that focus on personalized counseling.
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T2) Intensive counseling + lipid based supplementation to children 6–18 months (“Kalina Zaza”), delivered in a weekly ration of supplement providing 20 g/day/child.
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T3) Intensive counseling + lipid based supplementation to children 6–18 months + pregnant and lactating women [−6,+6] (“Kalina Reny”), delivered in a weekly ration of supplement providing 20 g/day/child plus 40 g/day/pregnant women and mothers of children who are 0–6 months old.
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T4) Intensive counseling on infant and young child feeding practices + early childhood stimulation for children 6–24 months
T0: The status quo program
T1 Intensive counseling
T2 Intensive counseling + LNS for children
Nutrient | WHO/FAO RNIs for children 1–3 ya
| IOM RDAs for pregnant womenb
| LNS child (Kalina Zaza) | LNS pregnant/Lactating women (Kalina Reny) | ||
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Content | %RNI | Content | %RDA | |||
Daily dose, g | 20 | 40 | ||||
Energy, kcal | 118 | 235 | ||||
Fat, g | 9.9 | 19.7 | ||||
Protein, g | 2.6 | 5.2 | ||||
Vitamins
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Vitamin A, μg | 400 | 750 | 400 | 100 % | 800 | 107 % |
Vitamin Dc, μg | 10 | 15 | 10 | 100 % | 15 | 100 % |
Vitamin E, mg | 5 | 15 | 6 | 120 % | 20 | 133 % |
Vitamin K, μg | 15 | 90 | 30 | 200 % | 45 | 50 % |
Vitamin C, mg | 30 | 85 | 30 | 100 % | 100 | 118 % |
Folic acidd, μg | 150 | 400 | 150 | 100 % | 400 | 100 % |
Thiamine (B1), mg | 0.5 | 1.4 | 0.5 | 100 % | 2.8 | 200 % |
Riboflavin (B2), mg | 0.5 | 1.4 | 0.5 | 100 % | 2.8 | 200 % |
Niacin, mg | 6 | 18 | 6 | 100 % | 36 | 200 % |
Pantothenic acid (B5), mg | 2 | 6 | 2 | 100 % | 7 | 117 % |
Vitamin B6, mg | 0.5 | 1.9 | 0.5 | 100 % | 3.8 | 200 % |
Vitamin B12, μg | 0.9 | 2.6 | 0.9 | 100 % | 5.2 | 200 % |
Minerals
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Calcium, mg | 500 | 1000 | 280 | 56 % | 500 | 50 % |
Copper, mg | 0.56 | 1 | 0.34 | 61 % | 4 | 400 % |
Iodine, μg | 90 | 220 | 90 | 100 % | 250 | 114 % |
Irond, mg | 11.6 | 60 | 6 | 52 % | 30 | 50 % |
Magnesium, mg | 60 | 360 | 40 | 67 % | 150 | 42 % |
Manganese, mg | 1.2 | 11 | 1.2 | 100 % | 2.6 | 24 % |
Phosphorous, mg | 460 | 700 | 190 | 41 % | 400 | 57 % |
Potassium, mg | 700 | 4700 | 200 | 29 % | 1000 | 21 % |
Selenium, μg | 17 | 400 | 20 | 118 % | 130 | 33 % |
Zinc, mg | 8.3 | 11 | 8 | 96 % | 30 | 273 % |
T3 intensive counseling + LNS for pregnant and lactating women + LNS for children
T4: integrated counseling on nutrition and early stimulation/home visiting
Community and participant eligibility criteria, study setting, and enrollment strategy
Outcomes
Outcome
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Instrument
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Notes
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Timing of data collection
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Nutritional outcomes:
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Height/length | Stadiometer (children and caregivers) (locally made, with 1 mm gradations) | Length/height will be measured to the nearest 0.1 cm | Baseline, midline, endline (mothers/caregivers at endline only) |
Weight | Electronic mother-baby weighing scale with reading increments of 10 g (SECA Model 874) | Weight will be measured to the nearest 100 g. Duplicate measures will be repeated if the difference between the measurements is >0.1 kg. | Baseline, midline, endline |
Anemia/Hemoglobin | Hemocue Hb 301 portable photometer | Measurements will be obtained to the nearest 0.1 g/dL | Baseline, midline, endline (subsample) |
Iron and vitamin A status | Enzyme-linked immunoassay (ELISA) method | Capillary blood samples in children 18-24 months | Endline (subsample) |
Child development outcomes:
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Language and cognitive and socio-emotional development | Ages and Stages Questionnaire: Inventory [51] | Combination of primary caregivers report and direct observation of children 0–36 mo [52] | Baseline, midline, endline |
Bayley Scale [53] | Direct assessment (children 28-34 months) | Endline (subsample) | |
Intermediate indicators
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Household food security | Household Food Security Questionnaire (FANTA) | Questions adapted and modified to reflect the cultural context, as needed. | |
Maternal knowledge on nutrition and child development | Questions developed to determine what knowledge is retained from the nutrition education sessions, group activities and/or home visits. | Questions on correct identification of symptoms of illnesses, malnutrition and markers of appropriate child development | Baseline, midline, endline |
Food diversity, maternal and child diet | 24 h food recall and food diversity score for pregnant women, mothers and children (FANTA, FAO, WHO) | Questions adapted and modified to reflect the cultural context, as needed. | Baseline, midline, endline |
Appetite and responsive feeding | Module adapted from Alive and Thrive | Questions adapted and modified to reflect the cultural context, as needed. | Baseline and midline |
Maternal child stimulation | Family Care indicator scale (FCI) [54] | Questions to mothers/caregivers regarding household items for child stimulation (e.g. books and toys), and activities (e.g. reading, singing playing). | Baseline, midline, endline |
Maternal time use and time spent with child | 24 h recall in time spent across different activities, including time spent with target child | Baseline, midline, endline | |
Maternal receptive vocabulary | Peabody Picture Vocabulary Test (PPVT) [55] | Administered to pregnant women, primary caregivers and community nutrition workers | Baseline |
Maternal depressive symptoms | Center for Epidemiologic Studies Depression Scale (CES-D) [56] | Baseline, midline, endline |
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a household questionnaire with detailed sections on demographics, housing/water and sanitation, education, household expenditures, food security, shocks, and anthropometry. The household questionnaire will be administered to the household head, or in his/her absence to the most informed household member.
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a female questionnaire administered to all primary caregivers of the eligible children as well as all pregnant women. Pregnant women will be asked questions on prenatal care, morbidity and a 24 h food recall, knowledge about nutrition, hygiene and stimulation, a depressive symptoms module (based on the Center for Epidemiological Studies-Depression short form, or CESD, but adapted and simplified for use in the survey) and a test of receptive vocabulary (the Peabody Picture Vocabulary Test, or PPVT), which we have used previously in Madagascar [41]. At endline a specific module on LNS will be developed in the LNS treatment arms, with questions about availability, acceptability, and use, as well as perceived benefits from the supplementation.
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a child questionnaire administered to all primary caregivers includes a retrospective report on delivery and birth of the child, breastfeeding history and status, timing of introduction of complementary feeding, a module on appetite and responsive feeding, and a 24 h food recall. Mothers or primary caregivers of the target child will also be administered a questionnaire on stimulation practices (using the Family Care Indicators) and a questionnaire on child development (Ages and Stages Questionnaire: Inventory) while this assessment is primarily administered to the mothers/caregivers, there are also opportunities for the children to demonstrate behaviors for the interviewer.
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a community nutrition worker questionnaire, with key socioeconomic characteristics, a module on their experience and organization of the program activities, a motivation scale, a knowledge module, and a test of receptive vocabulary (PPVT) [41].
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a village questionnaire, with key village infrastructure, village level agro-climatic shocks, and a price questionnaire.