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There were two formulations of Atole depending on age: one for children <4 mo of age made up of powdered skim milk and sugar (28,8 and 3.6 g, respectively, per 180 mL) and one for older children and mothers containing Incaparina, skim milk and sugar (13,5 ▒ 21.6 and 9.0 g, respectively, per 180 mL). Very little of the milk supplement was consumed by children <4 mo of age. The Atole for older children was pale gray-green, and tasted smooth but slightly gritty and sweet; it was served hot. The energy, protein and micronutrient contents of the Atole are shown in Table 2.

In October of 1971, the riboflavin content of the Atole for children >4 mon was raised from 0.5 mg to 1.5 mg per serving after noting that the biochemical indices of riboflavin were not satisfactory in 2-y-old children consuming Atole (Habicht et al. 1973). Iron and a small amount of ascorbic acid to facilitate iron absorption also were added because anemia was common in pregnant mothers; however, anemia was not found in unsupplemented 2-y-old children (Habicht et al.1973). The thiamin and niacin contents increased because they were present in the iron-vitamin mix. On the basis of calculations from knowledge about water fluoridation (Infante 1975), fluoride was also added at this time because the drinking water had a low fluoride content at the end of the dry season 0.166-0.384 ppm compared with the recommended 1 ppm) when the concentrations should be highest and because of the high incidence of dental caries in the communities (Infante and Gillespie 1976; Infante and Gillespie 1977).

The comparison beverage, Fresco, was a low-calorie supplement containing 247 kJ (59 kcal) and no protein per serving. It was a cool, clear-colored, fruit-flavored drink similar to KoolAid™ (sold in the USA. The ingredients and nutrient content of the Fresco are given in Table 2. Previous to 1971, it contained only flavoring, color and sugar. In October 1, 1971 other nutrients were added to make it more similar to the Atole. Many of these nutrients had been found to be marginal after review of biochemical indicators in blood and urine in children who drank the Fresco regularly (Habicht et al. 1973).

In all villages, the supplements were distributed and consumed in a centrally located, feeding hall for 2-3 h during midmorning and midafternoon, including weekends. These times were chosen because they were easiest for mothers and children to attend and because they did not interfere with usual meal times.

Medical care. Curative medical care was available on week days and free of charge throughout the duration of the study at a clinic adjacent to the beverage feeding halls. These services were available for all residents and were not tied to participation in any aspect of the study. The medical care program was justified not only on ethical grounds but on design considerations as well. For example, immunizations would prevent an epidemic from striking one village and not another as had happened in a previous INCAP nutrition field trial, with dire consequences for data interpretation.

The new system of curative care was implemented in the fall of 1969 (Working Group 1973). Effective but affordable medical care was provided through auxiliary nurses instead of physicians and by streamlining the purchasing and use of medicines. It featured continuous supervision of adequacy of the quality of history taking, diagnosis and treatment (Habicht 1979). Cases that could not be diagnosed by the auxiliary nurses were referred to the supervisory physician (<1% of cases). Furthermore, arrangements were made with Hospital Roosevelt, a teaching hospital in Guatemala City, to honor referrals (0.4% of cases) and keep INCAP informed of patients' progress and discharge. By early 1971, the quality of care had stabilized and >99% of cases were managed correctly (Working Group 1973).

The local traditional midwives were funded to attend midwifery courses given by the Guatemalan public health authorities. Their care complemented that given on demand by the nurses.

All children were examined 15 d after birth by a well trained pediatrician for diagnosis and treatment of any neonatal ills. The pediatrician also examined the children at 3 mo and at 1, 3 and 7 y to detect any remediable pathology that had escaped the clinic's attention. Pregnant mothers were immunized against tetanus and children against tuberculosis, diphtheria, whooping cough, tetanus, measles and poliomyelitis (Habicht et al. 1979). Deworming medicines were offered twice a year, but the medical program did not give health or nutrition education, except to encourage attendance to the supplementation feeding stations and to participate in immunization campaigns. The curative and preventive health care services were the same in all the villages, and any preventive campaigns such as deworming or immunization were done simultaneously in all the villages.

Compared with rates for the period previous to 1969, infant mortality had declined by 1970-72 from 139 to 55 deaths per 1000 births and preschool mortality had decreased from 28 to 6 deaths per 1000 children at risk, at a total cost for primary health care of<$5 per villager per year. National death rates in Guatemala remained constant during this comparison period. Data collected in 1988-89 confirmed these declines in mortality rates (Rose et al. 1992).

Other influences of the study team. The intensity of data collection and the supplementation and medical interventions required the continuous presence of four to eight well-educated persons in each village. Although they did not live in the villages, at least one of them visited each family twice a month. The influence of these contacts could be variable depending upon the personalities of the personnel and therefore could have affected the outcomes of the study differentially across villages. Therefore all personnel were rotated through all the villages for equal durations of time.

Sample persons, data collection and data availability. All women who were pregnant or lactating and all children from birth to 7 y of age were included in the original design of the INCAP longitudinal study if they lived in the study villages from January 1,1969 to February 28, 1977. Absence from the village was the most common cause for missing data. Refusal to participate in the study was rare; <2% of all families declined participation. Anthropometric data are available for 517 different women for one or more of their pregnancies and corresponding lactation periods. The distribution by birth date cohort of the children with one anthropometric examination or more (n = 1992) is presented in Table 3 by village type. The cohorts identify children with different exposure to supplementation during the critical periods of gestation and the first 3 y of life.

TABLE 3 Children with anthropometry╣ by birth cohort in Atole and Fresco villages

Cohort number

Birth cohorts

Exposure period

Atole

Fresco

Total

I

│1 March 1974

Gestation, partial birth to 3 y

260

280

540

II

1 March 1969-28 February 1974

Partial during gestation,2, all birth to 3 y

374

395

769

III

1 January 1966-28 February 1969

Partial birth to 3 y

185

194

379

IV

│1 January 1966

No exposure during gestation or birth to 3 y

151

153

304

Total

970

1022

1992

╣ With data for birthweight or for any of the anthropometric postnatal examinations.
▓ Some cases in the early part of the study may not have had full exposure to supplement during pregnancy.

Details of data collection are shown in Table 4. Most data collection began January 1, 1969 in the large villages and somewhat later (range March to May) in the small villages. All data collection ceased in September 1977 but cessation occurred as early as March 1977 for some types of information. Data-collection methods are described in detail in a manual of standard operating procedures in which the forms used are also presented (Division de Desarrollo Humano 1971). Table 4 also lists data collected in cross-sectional surveys conducted in collaboration with the Rand Corporation in 1974-76; additional details are given elsewhere (Corona 1980). Short descriptions of the type of data collected in key areas are presented below.

Census and socioeconomic data. A census was conducted in the four villages at the end of 1968. This was updated whenever the dietary-morbidity interviewers in their fortnightly home visits identified changes in household composition, new families (new marriages/unions or in-migrants), changes in residency within the village and out-migration. This updating of the census was verified by a cross-sectional census in 1974.

TABLE 4 Data collected in the INCAP longitudinal study, 1969-1977

Type of data

For whom (Target)

When collected

Where collected

By-whom

Collection dates

Supplement intake

Children 0-7 y and pregnant and lactating women

Everyday

Feeding Centers

Supplementation supervisors

1969-77

Morbidity, breastfeeding and menstruation recall

Children 0-7 y and pregnant and lactating women

every 15 days

Home

Dietary and Morbidity Interviewers

1969-77

Diet: 24-h recall in large villages and 72-h recall in small villages

Children 0-12 mo

Monthly

Home

Dietary

1973-77


Children 15-36 mo

Every 3 mo

Home

Morbidity

1969-77


Children 42-60 ma

Every 6 mo

Home

Interviewers

1969-77


All pregnant women

Every trimester

Home

Dietary and morbidity interviewers

1969-77


Lactating mothers






0-12 mo

Every 3 mo

Home

Dietary

1969-77


15-36 ma

Every 3 mo

Home

Morbidity interviewers

1973-77


Other mothers

3, 6, 9 & 18 mo post partum

Home

Dietary and morbidity interviewers

1973-77

Birth weight, birth process and Apgar anthropometric indicators of nutritional status

Children 0-7 y

At birth

Home

Perinatologist

1969-77


Children 15 d-24 mo

Every 3 mo

Clinic

Child Anthrop.

1969-77


Children 30-48 mo

Every 6 mo

Clinic

Child Anthrop.

1969-77


Children 60-84 ma

Every year

Clinic

Child Anthrop.

1969-77


Pregnant and lactating women

During each trimester of pregnancy or lactation

Clinic

Maternal anthropometrist

1971-77

Hand-wrist x-rays

All children

At 3 mo. From 6 to 48 mo every 6 mo At 60, 72 and 84 mo

Clinic

Child anthropometrist

1969-77

Mental development Cognitive infant scale

Children 6-24 mo

At 6, 15 and 24 months

Test room in village

Psychometrist

1969-77

Preschool battery

Children 36-84 mo

Every year

Test room in village

Psychometrist

1969-77

Physicalexamination

Children 0-7y

15 d; 3 mo;1,3 and y

Clinic

Pediatrician

1971_77

Prenatal examinations

Pregnant women

Each trimester of pregnancy

Clinic

Auxiliary nurses

1969-77

Reproductive histories

Pregnant women

First prenatal examination

Clinic

Auxiliary nurses

1969-77

Records of visits to outpatient clinics

Children 0-7 y and pregnant and lactating women attending the medical clinic for any reason

For all visits for therapeutic care; Monday through Friday

Medical clinic

Auxiliary nurses

1971-77

Census and socioeconomic information

Families in community

Twice

Home

Census interviewers

1968-1969

Changes in household composition through census updates

Families in community

Every 15 days

Home

Dietary and morbidity interviewers

1968-1969

Father's anthropometry

Fathers of children in study

Once (cross-sectional)

Home

Child anthropometrist

1973-75

Retrospective life history of women (fertility, infant mortality and maternal employment)

Women 15-49 y ever in a marriage/union or ever a mother

Once (cross-sectional)

Home

Interviewer

1974-75

Income and wealth

Heads of household

Once (cross-sectional)

Home

Interviewer

1974-75

Attitudes and expectations of women

Women 15-49 y ever in a marriage/union or ever a mother

Once (cross-sectional)

Home

Interviewer

1975-76

Attitudes and expectations of men and retropective life history of men

One-half of the husbands of respondents to the "retrospective life history of women" and one-half of all single men

Once (cross-sectional)

Home

Interviewer

1975-76

The informant was the mother or other primary caretaker. Data collected included information about family structure, marital status, religion, number of pregnancies, number of children alive and relation of the nuclear family to the head of the extended family, and about ownership of items such as radios, sewing machines, refrigerators, bicycles and motor vehicles. Information about parental literacy was obtained through interviews and also through tests. Status (e.g., alive, dead, immigrated), birth order, kinship (e.g., father, son, adopted), parity (for mothers), schooling and occupation (for those older than 10 y) were recorded for each household member. Observations were noted about the house such as the types of walls, floor and roof, availability of electricity, type of water source and of grey water and feces disposal. Whenever a change occurred in the location of the home or in the status or kinship of a family member, the date of the change was noted.

Psychometric data. Full descriptions of the psychometric tests are given by Klein et al.(1977) and by Engle et al. (1992b). Neonates were tested within 10 d of birth. with the Brazelton Neonatal Scale and then at 6, 15 and 24 mo with an infant scale composed of items compiled from the Bayley, Cattell, Gesell and Merrill-Palmer Infant Scales. From 3-7 y of age the children were tested annually on a battery of 24 tests chosen to tap memory, language, perceptual reasoning, learning and abstract reasoning ability.

Supplementation. Supplementation and measurement of attendance and consumption began on January 1, 1969 in the large villages and on May 1, 1969 in the small villages. Attendance at the supplementation feeding station was recorded for all sample persons. The supplement was poured into cups calibrated to 180 ml. Cups were filled as often as requested. Individual intake was measured by recording the number of cups given and subtracting any leftover supplement measured to the nearest 10 mL.

All leftovers were poured into a large vessel. At the end of the serving period, the total amount recorded as ingested and the total amount served minus the volume of leftovers were compared. Calculations based on these data showed that reliability for supplement ingested was better than 99% per cup served. The reliability of concern in this study is of intakes during a week or longer periods; that reliability is almost perfect.

Home diet. Information on the home diets of children, pregnant and lactating women was collected according to the schedule indicated in Table 4. Daily home diet was estimated from 24-h recall surveys in the large villages and from 3-d recall surveys in the small villages. The amounts of food ingested were recorded in grams according to the usual INCAP recall method (Flores et al. 1970) and then converted to energy and nutrients using the INCAP food composition tables (Flores et al. 1960; Flores et al. 1971). The reliability of the dietary data was, however, found to be equally poor for both recall methods (División de Desarrollo Humano 1971, Habicht et al. 1974; Klein et al. 1973; Lechtig et al. 1976). Energy and protein had the highest reliabilities of all nutrients but these were only of the order of 0.15-0.30.

Medical care. Records of the presenting complaints, diagnoses and treatments were kept for all visits for use in the quality control system but, unfortunately, are no longer available. As of 1971, the symptomatology was recorded for each visit on the same form as the fortnightly morbidity data collected in the home and those data are available.

Morbidity, breast feeding and menstruation. Morbidity data were gathered every 14 d through retrospective interviews of mothers in the home by four home visitors, one for each village. The home visitors were rotated periodically among the four villages to offset interviewer bias. Interviews took place Monday through Friday, the families being so divided that routinely the entire population of each village was interviewed every 2 wk. During the interview, the mother was asked to recall any symptoms that she and any of her children younger than 7 years might have had in the previous 2 wk. Each subject's information was recorded in a separate questionnaire. The beginning and ending dates of a symptom were always noted. A routine quality-control system was applied allowing the method to be standardized, using a supervisor, and validated, using a physician. Information on menstruation in the mother (beginning and ending dates) were recorded or noted as absent in the morbidity questionnaire for the youngest child. Also noted was whether or not the child was breast fed.

To validate the morbidity survey, a physician examined children half a day after the morbidity visit without previously informing the morbidity interviewer. This study generally showed satisfactory sensitivities and specificities for the symptoms recorded. Sensitivity and specificity were 66% and 99%, respectively for diarrhea and 75% and 99% for fever (Martorell et al. 1975b).

A study of the prevalence of recalled symptoms over the 14 d between periodic surveys showed a fall in prevalence with respect to the day of interview indicating memory loss over the 2-wk period (Martorell et al. 1976). In spite of an average underreporting of 22%, diarrhea was nevertheless reported reliably enough to reveal statistically significant associations between percent of time ill with diarrhea and growth Martorell et al. 1975b; Schroeder et al. 1995).

Anthropometry. Body measurements were taken at specific ages by trained and standardized anthropometrists. A single person measured mothers throughout the study but three persons measured children at different times. All changes in personnel were preceded by rigorous standardization sessions.

The techniques of measurement are given in Martorell et al. (1982) and the quality control procedures used are described in Martorell et al. (1975a). Each week the data collected in the field were brought to the INCAP headquarters, computerized and analyzed. All children with values beyond two standard deviations from the agespecific means were remeasured for all variables to determine whether or not there had been an error in measurement, recording or punching. There was a weekly calibration of instruments, frequent standardization exercises for the anthropometrist at an urban orphanage and field replications. These exercises permitted the monitoring of precision and reliability; results of these exercises are given in Martorell et al. (1975a).

The anthropometry standardization method (Habicht 1974) is widely used today. Comparison of the reliability and precision achieved during the longitudinal study to results from others (Lehman et al. 1988; Marks et al. 1989;) speak favorably of the quality of the INCAP data.

Hand-wrist roentgenograms. The anthropometrist also took an X-ray of the left hand and wrist of children using a General Electric X-ray machine (model 100-15) set at 15 mA and 65 kV and using power from a gasoline generator. The X-ray head was set at 76 cm above the third metacarpal of the left hand with the fingers moderately splayed and the forearm placed at a right angle to the X-ray beam. Exposure was 48/60 of a second for children <2 y, and one second for older children. X-rays were taken at the ages specified in Table 4 concurrently with anthropometry.

Great care was taken to protect the children from stray X-rays. The X-ray film was placed in a lead lined box attached to the head of the X-ray machine. The seated child placed the hand into the box through a lead curtain. A film was placed on the child's seat and developed every month to be sure that there was no stray radiation.

The films were read for the number of ossification centers and the thickness of compact bone. Initially bone age also was determined according to the Tanner Whitehouse and the Greulich and Pyle methods. These detailed assessments were discontinued when analyses showed that the simple counting of ossification centers provided as much information (Yarbrough et al. 1973).

Physical examination. A pediatrician examined children at 15 d and at 3, 12, 36 and 84 mo of age to identify developmental and other problems and gave special attention to neurological function and minor anomalies indicative of congenital mental retardation or neurological impairment. This information would permit one to identify children whose association between less adequate nutrition and impaired mental development was probably due to the latter - impaired behavior leading to inadequate bonding and poor coping, both of which might result in malnutrition. It was also thought that the neurological data might reflect improved nutrition from the supplement. None of these data have been analyzed and published.


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