Methods
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Study design: Quasi‐experimental study |
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Unit of randomization: Nonrandomized |
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Type of study: Balanced Energy Protein |
Participants
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Location/Setting: Keneba, The Gambia, West Africa |
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Population: Not specified |
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Sample size: 385 |
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Drop outs/withdrawal: Not specified |
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Socio‐demographics
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Mean (SD) age: Not specified |
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Occupation: Not specified |
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Race: Not specified |
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Education: Not specified |
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Family income: Not specified |
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Inclusion criteria: All pregnant women in Keneba |
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Exclusion criteria: Twins were excluded |
Interventions
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Intervention (sample size):
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Post‐supplementation: Supplementation consisted of locally formulated biscuits and tea. The biscuits were composed of 468 kcal energy, 17.4 g protein, 25.5 g fat,180 mg Calcium, riboflavin 0.23, 0 μg vitamin A, 0 mg vitamin C. The tea was composed of 78 kcal energy, 2.9 g protein, 1.6 g fat, calcium 95 μg, vitamin C 10 mg. Maximum intake of the biscuits was limited to three 65 g biscuit and 380 g tea in the dry season and four 65 g biscuits and 380 g tea in the hungry season. Supplementation was provided every morning besides Sundays and public holidays. In Ramadan, the supplementation was carried out at night. Women were enrolled into the program as soon as their pregnancy was discovered and so the average duration of supplementation was 24 weeks. The supplements in the intervention arm were delivered by villagers (n = 200) |
Control (sample size):
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Pre‐Supplementation group: All subjects had daily access to a sophisticated level of healthcare provided by a resident midwife and paediatrician. All women were provided 6 weekly follow‐up at antenatal and postnatal clinics. This care included: monitoring of vitals, fetal growth, fetal heart rate, fetal presentation, immunization against tetanus, screening urine for infection and screening blood for anaemia and malaria. All women were also provided with 47 mg ferrous sulphate and folate. Major obstetrical difficulties were referred to the hospital for delivery. The supplements were delivered by villagers (n = 185) |
Concomitant interventions:
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All healthcare provided to the control group was also provided to the intervention group as a baseline |
Training: Midwives were trained to assist traditional birth attendants |
Follow‐up:
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All women were provided 6 weekly follow‐up at antenatal and postnatal clinics. This care included: monitoring of vitals, fetal growth, fetal heart rate, fetal presentation, immunization against tetanus, screening urine for infection and screening blood for anaemia and malaria |
Outcomes
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Primary outcomes: None |
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Secondary outcomes:
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Low birthweight |
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Small‐for‐gestational age |
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Birth weight |
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Timing of outcome assessment: Birth weights were recorded within 24 h of birth |
Notes
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Study start date: 1976 |
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Study end date: 1984 |
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Time period: 8 years |
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Study country: The Gambia |
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Study limitations:
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The authors used retrospective controls. Also, the effect on neonatal mortality cannot be assessed directly due to small numbers |
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Funding source: Not specified |
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Conflict of interest: Not specified |