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Articles

Food Supplementation with Encouragement to Feed It to Infants from 4 to 12 Months of Age Has a Small Impact on Weight Gain^{1 ,4}

Nita Bhandari^*, Rajiv Bahl^*, Brinda Nayyar^*, Poonam Khokhar^*, Jon E Rohde and M. K. Bhan^*2

^* Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India and United Nations Children’s Fund, United Nations Children’s Fund House, New Delhi, 110003, India.

²To whom correspondence should be addressed. E-mail: community.research{at}cih.uib.no

	ABSTRACT

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
It is unclear whether a substantial decline in malnutrition among infants in developing countries can be achieved by increasing food availability and nutrition counseling without concurrent morbidity-reducing interventions. The study was designed to determine whether provision of generous amounts of a micronutrient-fortified food supplement supported by counseling or nutritional counseling alone would significantly improve physical growth between 4 and 12 mo of age. In a controlled trial, 418 infants 4 mo of age were individually randomized to one of the four groups and followed until 12 mo of age. The first group received a milk-based cereal and nutritional counseling; the second group monthly nutritional counseling alone. To control for the effect of twice-weekly home visits for morbidity ascertainment, similar visits were made in one of the control groups (visitation group); the fourth group received no intervention. The median energy intake from nonbreast milk sources was higher in the food supplementation group than in the visitation group by 1212 kJ at 26 wk (P < 0.001), 1739 kJ at 38 wk (P < 0.001) and 2257 kJ at 52 wk (P < 0.001). The food supplementation infants gained 250 g (95% confidence interval: 20–480 g) more weight than did the visitation group. The difference in the mean increment in length during the study was 0.4 cm (95% confidence interval: -0.1–0.9 cm). The nutritional counseling group had higher energy intakes ranging from 280 to 752 kJ at different ages (P < 0.05 at all ages) but no significant benefit on weight and length increments. Methods to enhance the impact of these interventions need to be identified.

KEY WORDS: • food supplementation • nutritional counseling • feeding advice • infant feeding • infant growth

	INTRODUCTION

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Malnutrition is a major public health problem in south Asia and Africa. In north Indian slums, 50% of children are stunted and 17% wasted by the age of 1 y (1 ,2) . Early growth faltering may be explained by low birth weight, inappropriate feeding practices and high morbidity rates (3) . The low intake of complementary foods after 4 to 6 mo of age is the result of inappropriate family perceptions about the needs of the infant and the complexity of preparing nutritionally adequate complementary foods suitable for infants due to limited access to appropriate ingredients and readily usable fuel. Furthermore, mothers often discontinue use of complementary foods during illness assuming that the illness may be related to the consumed foods. Children may also consume less during illness because of anorexia (4) .

An important question is whether the generous availability of a ready to use nutritionally adequate complementary food supported by intense encouragement to use it in optimal amounts, started at 4 mo and continued through 12 mo of age, will substantially prevent growth faltering during the latter half of infancy in low socioeconomic settings with concurrent high morbidity rates.

Efficacy trials of food supplementation during infancy improved infant dietary intakes by 272-1262 kJ/d and infant growth by 0.04–0.46 SD (5 6 7 8 9 10 11 12) . The small to moderate impact observed may be because increased food availability was not supported with sufficient encouragement to feed the child to achieve the desired energy intakes. In trials in which this constraint was removed, the duration of supplementation was only 3 mo, which may have been too short to have an impact (13) .

This randomized, controlled trial was conducted to determine the growth impact of two interventions. The first was provision of a precooked complementary food appropriate in quality and to be given daily from 4 to 12 mo of age with encouragement to use in optimal amounts. The second intervention was nutritional counseling alone.

	MATERIALS AND METHODS

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Study setting.

The study was conducted in South Delhi, the urban slum of Nehru Place. Most inhabitants are migrants to the city from rural areas in search of employment. The dwellings, 7000 or so in number, are made of mud, concrete or a mixture. The majority of the population (90%) obtains water from public hand pumps, the remainder through taps. Community toilets for defecation are poorly maintained and people often defecate in the open. Of families, 90% are nuclear. Most women (80%) and 40% of men have never been to school. The median family income is 2000 Rupees (United States: $50) per month (1 ,2) . At the prevailing prices, access to milk, legumes and vegetables is limited. Childhood malnutrition is common; 17% of children are wasted and 50% are stunted at 1 y of age. Morbidity rates are exceptionally high with a diarrheal incidence of 6–8 episodes/child each year and pneumonia of 1.6 episodes/child each year (1 ,2) .

Enrollment randomization and interventions.

The study was approved by the All India Institute of Medical Sciences Ethics Committee. In a household survey of the entire slum, we identified all pregnancies and infants under 4 mo of age. Four hundred and eighteen subjects were enrolled as they reached the age of 4 mo if written informed consent was available. Infants of families likely to emigrate during the study or with major congenital malformations were excluded. After a clinical examination, 24-h dietary recalls and weights and lengths were obtained for all children at baseline. Children were stratified by weight for height status ( 80% and > 80% of the National Center for Health Statistics median for that age) and randomly assigned to one of the four study groups.

The food supplementation group received a milk cereal supplement and mothers were advised to add 50 mL of warm water to the contents of one food packet at the time of offering it to the child. Individual packets of 50 g each were prepared by the National Dairy Development Board at Anand, Gujarat; the energy and nutrient content of the mixture is shown in Table 1 . The packets were delivered at home during the twice-weekly visits for morbidity ascertainment. The number of packets advised per day was 2 at 4–5 mo, 3 at 6–7 mo, 4 at 8–9 mo and 5 at 10–11 mo of age. At these advised intakes the children would receive between 1 and 2 recommended daily allowance of micronutrients listed in Table 1 . Mothers were recommended to continue breastfeeding and to give infants the usual home foods. At each twice-weekly visit, day-wise intake of the packet (since the last visit) was ascertained by asking the mother and the empty and partly used wrappers were collected. The study supervisor (a physician) visited the food supplementation children every month, reviewed the use of the supplement, emphasized the optimal amounts to be fed, fed the child in the mother’s presence and demonstrated that the child could consume the advised amounts if the mother reported nonacceptability. Caretakers were asked whether they required supplement for the other siblings and additional packets were given, if requested.

The visitation group children had only twice-weekly home visits for assessment of morbidity; no counseling or advice of any type was provided.

The children assigned to the no intervention group were only contacted at 6, 9 and 12 mo of age for anthropometry and dietary recalls as for the other groups; no other visits were made and no advice was given.

Routine immunization was ensured for all children. Children were encouraged to visit the study clinic when ill and free treatment was provided according to World Health Organization guidelines (15) .

Measurement of outcomes.

Enrolled infants were visited at home at 6, 9 and 12 mo of age for 24-h dietary recalls and weight measurements in duplicate (Seca scale, sensitivity: 10 g) and length in triplicate (infantometers, sensitivity: 0.1 cm).

At the twice-weekly morbidity visits, mothers were queried about cough, fever and diarrhea and the child was examined for respiratory rate (irrespective of cough), lower chest indrawing and signs of dehydration. Dysentery was defined as an episode of diarrhea in which visible blood was reported in stools. In the food supplementation group, supplement intake was also ascertained at these morbidity visits by reported consumption of packets categorized as one-fourth, one-half, three-fourths of packets and so on.

Sample size.

Based on data from an adjacent population (M.K.B., unpublished results), the sample size of 100 per cell was adequate to detect a 20% difference in mean weight or length increment during the 4- to 12-mo period between the food supplementation or nutritional counseling group and the visitation group with 95% confidence and 90% power.

Training, standardization and supervision.

Personnel were trained in anthropometric measurements, morbidity assessment and interview techniques for 3 mo before study initiation. Standardization exercises for inter- and intraobserver variability in weight and length were performed in which each child was measured twice. The study commenced only when all the field workers obtained identical readings in both their weight measurements on a child and were in perfect agreement with the supervisor’s readings. For length, a difference of up to ± 0.5 cm between the two readings of a field worker and between the readings of the supervisor and a field worker was considered acceptable. Exercises were repeated every 3 mo during the study.

The accuracy of the weighing scales was checked daily against known weights.

Data analysis.

The visitation group was chosen a priori as the control group for comparison with intervention groups to eliminate the unintended effects of repeated household visits.

Analyses of anthropometric outcomes (26, 38 and 52 wk) were restricted to infants with measurements within 30 d of the scheduled date. The 24-h dietary recall data were also restricted to the same infants.

To determine median food supplement intakes at 26, 38 and 52 wk through reported consumption of packets, the amount of supplement consumed by each child over a 4-wk period (± 2 wk at that age) was used to obtain intakes per day.

Effect sizes in terms of SD shifts were calculated as the mean change in weight in the intervention group minus the mean change of the visitation group divided by the pooled SD of change for both groups.

Diarrhea was defined as the passage of three or more liquid stools in a 24-h period; two episodes were separated by at least a 72-h diarrhea-free interval. Dysentery was defined as three or more liquid stools in a 24-h period with reported visible blood in any of the stools. Cough with high respiratory rate ( 50/min) or lower chest indrawing defined an episode of acute lower respiratory infections (ALRI)³ . Two episodes of ALRI had to be separated by minimum 2-wk interval and that of fever by 1 wk.

The prevalence was calculated for each infant as the number of days with illness per 100 d of follow-up to obtain an estimate of each group’s mean prevalence.

To estimate the mean incidence per group, the incidence of illness was calculated for each infant as the number of episodes of that illness that had occurred in the follow-up period. Prevalence and incidence estimates were restricted to infants available for at least two-thirds of the follow-up period.

Analysis was done using Epi Info, Version 6.0 (CDC Atlanta, USA and WHO Geneva, Switzerland) and STATA, Version 6.0 software (Stata Corporation, Texas). Means were compared by analysis of variance and Student’s t test was used for individual group comparison. Kruskal-Wallis H test was used when the data were not normally distributed. ² test was used for comparison of categorical variables. Differences with P < 0.05 were considered significant.

	RESULTS

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The trial profile is given in Figure 1 . Four hundred and eighteen children were randomized and end study weight was available in 368 (88%). The common reasons for missing anthropometry were nonavailability of the family (72%), emigration (8%) and refusal to participate in the study after an initial consent (8%). Six infants died during the study, two each in the counseling and no intervention groups and one each in the food supplementation and visitation group. The baseline characteristics of the study children in whom end study anthropometry was available are shown in Table 2 .

View larger version (29K): [in this window] [in a new window]   Figure 1. Trial profile. Reasons for anthropometry not being done were family’s nonavailability (72%), family permanently moved (8%), refusal to participate after enrollment (8%) and death (12%).

Infants in the food supplementation group gained 250 g [95% confidence interval (CI): 20–480 g] more weight during the study than did the visitation group. The difference in the mean increment in length between the food supplementation group and visitation group was 0.4 cm (95% CI: -0.1–0.9 cm). The proportion of infants wasted at end study was not different between the food supplementation and visitation groups; the proportion stunted was reduced in the food supplementation group by;T3\tT4> 6.8% (95% CI: -6%–20%) but this was not significant (P = 0.16) (Tables 3 and 4 ). When compared to the no intervention group, the food supplementation children gained 100 g more in weight (95% CI: -120–320 g) and 0.4 cm (95% CI: -0.07–0.87 cm) in length during the study (Tables 3 and 4) .

There was no significant benefit of nutritional counseling on weight and length increments compared with either visitation or the no intervention groups (Tables 3 and 4) . The nutritional counseling group gained 90 g (95% CI: -96–276) more weight than did the visitation group during the entire study (Table 3) .

Impact on energy intakes.

Table 5 shows the median energy intakes from the supplement and from usual foods based on 24-h dietary recalls at 26, 38 and 52 wk. For the food supplementation group, the energy intakes derived through reported intakes at the twice-weekly household visits for morbidity assessment are also shown as a footnote.

Based on 24-h dietary recalls, the median intake of supplement was similar at 26, 38 and 52 wk. Accordingly, during the study the infants consumed 66% of the recommended daily allowance for vitamin A, 26% for vitamin D, 53% for calcium, 50% for iron and 60% for zinc from the food supplement alone.

Impact on breastfeeding.

The proportion of infants who were breastfed was significantly lower in the food supplementation group compared with the visitation group at 52 wk (difference in proportions: -12.8%; 95% CI: -4 to -21); it was marginally lower at 38 wk (difference in proportions: -5%; 95% CI: -12.3%–0.4%). Compared with the visitation group, the mean breastfeeding frequency was significantly lower at 26 wk (difference in means: -1.7; 95% CI: -2.7 to -0.7) and at 38 wk (difference in means: -1.2; 95% CI: -2.34 to -0.06) in the food supplementation group.

Nutritional counseling and visitation groups did not differ in proportion of infants breastfed or in the mean breastfeeding frequencies at 26, 39 and 52 wk of age.

Impact of morbidity.

The food supplementation group had significantly higher prevalence of fever and dysentery (P < 0.05) compared with the visitation group. Nutritional counseling did not affect morbidity. The incidence and prevalence of diarrhea and ALRI were not significantly affected by either intervention (Table 6 ).

	DISCUSSION

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

Several factors may have limited the growth impact, in spite of the reported high intakes of supplement. First, it is possible that the intakes may have been overreported partly as a result of the intense pressure on mothers to use the supplement and to account for the packets. The overreporting may have been higher for estimates based on use of packets at morbidity visits because the intake reported by mothers was rounded off to the nearest one-fourth of a packet. Second, although average reported intake improved considerably in the food group, energy intakes remained short of ideal requirements in a large proportion. For instance, at 9 mo of age, 42% infants did not consume the recommended 1881 kJ from nonbreast milk sources (16) .

Furthermore, energy intakes did not show the expected increase with progression in age, as was advised to the caretakers. As a result, the shortfall in energy and in nutrient intakes increased progressively until the end of the study. This is reflected in the trends in weight increments during different time intervals. The 250-g additional increment in the food supplementation group observed during the entire study compared with the visitation group occurred almost entirely in the 26- to 38-wk period, corresponding to a SD shift of 0.5. The inability to sustain accelerated growth beyond 38 wk despite availability of appropriate foods indicates that there are barriers related to offering of foods by caretakers or in their consumption by children at the recommended frequency or in desired portion sizes that may have persisted despite the intervention.

Reduction in breastfeeding in the supplemented children seems to be large enough to have potentially limited the growth impact of the intervention. Food supplementation interventions were also found to reduce breast milk intake in several earlier studies (12) . In studies in which such information was available, infants consumed 29–836 kJ/d less energy from breast milk because of being offered complementary foods (12) .

Increased morbidity has usually not been reported in food supplementation trials or programs (5 6 7 8 9 10 11 12 13 ,17) . In this trial, the increased morbidity in the food supplementation group infants may have been due to very high risk of contamination in this population as is evident from high diarrhea rates in all the groups. Contamination may have occurred during preparation of the supplement and while feeding the infant. Although caretakers were instructed to use boiled water for preparation of the food and to wash hands and utensils before feeding the infant, the compliance with these was not monitored. Decreased breastfeeding rates may have partly contributed to the increased morbidity. Exclusive as well as partial breastfeeding has been shown to provide significant protection against dysentery (18 ,19) . Finally, because a physician made additional home visits to encourage use of the supplement, some of the increased morbidity may be due to differential overreporting in this group.

Previous studies have shown reduction in consumption of usual foods as a result of supplementation (12) . In the current study when the visitation group was used for comparison, no reduction was observed in energy intakes from usual foods because of the food supplementation. The nonbreast milk energy intakes from usual foods were, however, reduced by 18%–36% at 26, 38 and 52 wk in the food supplementation group compared with the no intervention group and a possible negative impact of the supplement on usual food intakes, therefore, cannot be excluded.

Nutritional counseling significantly improved nonbreast milk energy intakes in comparison to the visitation group and the average increase ranged from 280 to 752 kJ/d at different measurement points during the study. This is similar to the findings of earlier studies (12) . Although this level of additional intake of energy and specific nutrients is important, there is a need to devise ways to make counseling more successful. It is likely that interventions targeted at the entire community rather than to individual mothers with effective communication support and community participation may improve impact by reducing cultural barriers to achieving optimal intakes.

In conclusion, increasing food intakes from 4 to 12 mo of age through food supplementation and encouragement to feed resulted in substantial increase in weight gain between 6 and 9 mo of age with little additional increment in the 16- to 26-wk and 38- to 52-wk periods. To improve the impact of food supplementation, careful attention must be paid to the possible detrimental effect on breastfeeding, intake of usual foods and morbidity. Nutritional counseling resulted in smaller but significant increases in dietary intake without affecting breastfeeding or morbidity. In addition to providing food and nutritional counseling, interventions are required to overcome other barriers to adoption of optimal feeding practices.

	ACKNOWLEDGMENTS

 
We acknowledge the core support of the Indian Council of Medical Research (ICMR) and the Norwegian Universities’ Committee for Development and Research (NUFU) to our unit. The National Dairy Development Board (NDDB), Anand, Gujarat provided the food supplement and Baljeet Kaur helped with the statistical analysis.

	FOOTNOTES

 
¹ Supported by United Nations Children’s Fund, Delhi.

³ Abbreviations used: ALRI, acute lower respiratory infections; CI, confidence interval.

⁴ For Commentary on this article see: J Nutr. 131: 1879-1880, 2001

Manuscript received November 8, 2000. Initial review completed December 12, 2000. Revision accepted April 5, 2001.

	REFERENCES

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 

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