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The INCAP longitudinal study (1969-77)

Objectives and design. The design eventually implemented in the INCAP longitudinal study called for comparison of outcomes in pregnant and lactating women and in their children between two pairs of villages exposed to different supplements. Read and Habicht (1992) state that the major motivation for the INCAP longitudinal study was to assess the impact of intrauterine and preschool malnutrition on behavior. Thus, food supplements were provided and their consumption measured in pregnant women and in children younger than 7 y of age.

Nutritional supplementation was to produce an unambiguous contrast between well and poorly nourished children. Because protein deficiency was perceived to be the major cause of malnutrition at the time the study was being planned (Scrimshaw and Behar 1965), major emphasis was placed on improving protein malnutrition while assuring enough extra energy to allow for protein utilization. The feeding intervention took advantage of INCAP's extensive experience with Incaparina (Bressani and Elias 1968), a nutritious gruel with a high-protein and moderateenergy content that was widely accepted in Guatemala. Thus, the pregnant mothers' and childrens' diets were improved with an Incaparina-based drink, referred to as "Atole", the Guatemalan name for a hot, maize gruel. This drink had to be prepared at the time of ingestion and therefore required a central kitchen and feeding hall.

The centrally located feeding stations precluded random allocation of treatment to individuals within a village; instead, allocation to treatment was by village within pairs chosen to be as similar as possible. One pair was large (~900 people per village) and one was small (~500 people per village).

The comparison beverage to this gruel was a sweet, cool, colored and fruit-flavored drink called "Fresco". Drinks of this type were much appreciated in the area. The Fresco was intended originally to be devoid of any nutritional value, in effect to be a placebo. It was envisaged as a control for the social stimulus and other factors associated with supplementation. The use of cyclamates for sweetening was considered but concern about carcinogenicity led to sugar being used instead, which of course introduced energy. Finally, other nutrients were introduced as discussed below in an attempt to narrow the contrast between the Atole and Fresco groups to differences in energy and above all in protein. Consequently, the Fresco should not be viewed as a placebo control to the Atole because it contained some energy and important concentrations of micronutrients. Instead, both drinks are referred to as "supplements".

Originally, three pairs of supplementation villages were specified, but budgetary constraints reduced the number of pairs to two. A less accessible pair of "large" villages was dropped early in the study with dire consequences for statistical power. As implemented, the effects of improved protein nutrition were to be ascertained through comparisons of results before and after the intervention in the two Atole and two Fresco villages. The before-after comparison was, however, only possible for selected variables collected with adequate sample sizes in 1968, before the intervention began, or for those variables collected in the first months of the study that could not be immediately affected by supplementation (e.g., height of 7y-old children). Issues of statistical power and analytic strategies in the study are discussed extensively by Habicht, Martorell and Rivera (1995).

The effect due to the study activities per se on behavior was to have been estimated by contrasting outcomes before and after the study in the villages not receiving protein (i.e., Fresco villages) to those in villages not visited in the interim, termed "Supercontrol" villages in project documents. However, budgetary constraints curtailed baseline data collection in these "Supercontrol" villages, nor were data collected in these communities in 1977, at the end of the INCAP longitudinal study.

Although the allocation of treatment across villages was random, ingestion of the supplements was voluntary and therefore subject to self-selection. The implication of this combination of random error and selfselection bias for data analysis and interpretation is discussed by Habicht, Martorell and Rivera (1995).

Finally, it is important to consider that conducting the study involved intensive contact between data collectors and villagers. The data-collection activities were designed and implemented to affect all villages equally and therefore cannot be a source of bias in the Fresco versus Atole contrasts. However, the study setting does affect the validity of extrapolations to other populations if its activities impacted on outcomes synergistically with the supplements. These same concerns apply to the medical care that was provided to the study villages; it too may have potentiated or diminished the impact of the supplements.

Village selection and description. Several needs were considered in selecting villages: population size, relatively compact settlements; to allow easy access to the centrally located feeding station and stability and homogeneity among villages. A further limitation was imposed by the psychometric testing. To find a large enough sample of mutually isolated villages speaking the same language, the study had to be located in the Spanish-speaking (i.e., Ladino) region of Guatemala instead of in the more picturesque Maya-speaking area where most previous INCAP research had been done. The selection and matching criteria that were used are presented in Table 1.

TABLE 1 Criteria for selecting and matching villages in the INCAP Longitudinal Study¹

¹ Adapted from Canosa et al. 1972.

Ultimately 10 villages were found to fulfill best these selection criteria from among 300 Ladino villages identified from maps as being within the selection radius and from the Guatemalan Census as having population sizes of 500-1000 inhabitants (Canvass et al. 1972). This was a time-consuming process entailing data collection in as many as 45 villages. Most of these data are lost except for some of the dietary, anthropometric, census and socioeconomic data collected in the four villages finally selected for the study. Some useful baseline information about the four study villages is given by Mejía-Pivaral (1972).

Analyses of baseline data indicated that three pairs of villages were most similar to each other: two pairs of villages within an hour's jeep ride from each other and a third pair of villages much further away. As noted earlier, the study was never fully implemented in the third pair of villages, Tapalapa and Santa Gertrudis. The final two pairs of villages selected were San Juan de las Flores and Espiritu Santo with ~500 inhabitants each and San Miguel de Conacaste and Santo Domingo los Ocotes with ~900 inhabitants each. All were far enough apart from each other to make intervillage contact unlikely.

The four villages selected are located in the Department of El Progreso, a dry, mountainous area northeast of Guatemala City. The large Fresco village (Santo Domingo) is closest to Guatemala City, at 36 km, whereas the small Fresco village (Espíritu Canto) is furthest, at 102 km. The elevation of the large Fresco village is 1250 m above sea level, whereas both Atole villages are at 860 meters, and the small Fresco village is at 275 meters. The average temperature range for the small Fresco village is 24-38°C, and for the other three villages it is ~14-32°C with the rainy season occurring from June to October. Two of the major crops in each village were corn and beans, with tomatoes also being a major crop in the large Atole (Conacaste) and small Fresco villages, sorghum in the large Fresco village, and maniac, locally known as "yuca," in the small Atole village (San Juan).

In 1967, <10% of the families in the four villages had a source of water in their homes. Almost everyone obtained water from open, unprotected hand-dug wells, and in the small Fresco village from a nearby river. Few households had a latrine, and no one had a sewage or drainage system.

In three of the four villages, the typical house had one to two rooms with adobe walls, dirt floors and a tile or metal roof. However, poorer families lived in houses with reed walls and thatched roofs. In the small Fresco village, where the climate is warmest, most houses, even those of better-off families, had thatched roofs, walls made of reeds and mud, and dirt floors. Families usually prepared food in either a separate room or in a separate area located just outside the house. Most people owned their homes, as well as at least some of the land around their homes. About onethird of the families had radios; only a few (<5%) owned a television, record player, refrigerator or bicycle. No homes were equipped with electricity.

The primary income for most villagers was from agricultural production. Almost all were tenant farmers or small-land owners. No one in any of the villages reported being a large landholder, and very few reported being merchants. Wage labor was reported as a principal occupation by 21% of the men in the small Fresco village and by 15% of the men in the small Atole village. Wage labor was not a significant source of income in the large villages. Very few women reported having occupations outside the household except in the small Fresco village, where they had the opportunity to make money independently through basket weaving.

Literacy was self-reported, usually by the mother of the family, for all family members. The percent of mothers at least partially literate in each village ranged from 25 to 40%. The large Fresco village had the highest literacy rate for mothers (40%). Literacy levels of the fathers ranged from 38 to 60% with those in the small Fresco village having the highest literacy rate. Additional data about the social, economic and demographic development of these villages are given by Bergeron (1992) and Engle et al (1992a).

The interventions: supplementation and medical care. Supplementation. The intervention design calls for comparisons of villages in which pregnant and lactating mothers and their children up to 7 y of age received verified and recorded amounts of either Atole or Fresco. Table 2 presents the ingredients and the energy and nutrient concentration of the supplements per one-cup serving (i.e 180 mL) as given elsewhere (División de Desarrollo Humano 1971; Martorell et al. 1982). The Atole contained a high-quality protein mixture whereas the Fresco contained none. The energy concentration of Atole for children older than 4 mo was 2.8 times greater than for Fresco.

TABLE 2 Formula and nutrient content of beverages per cup serving (180 mL)¹

¹ Higher values as of October 1, 1971.
² Values differ slightly for some ingredients and nutrients in project documents. Those given here are from the Manual de Operaciones issued by the División de Desarrollo Humano (1971).

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