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. 2021 Jun 21;17(2):e1150. doi: 10.1002/cl2.1150
Methods Study design: Quasi‐experimental study
Unit of randomization: Nonrandomized
Type of study: Balanced Energy Protein
Participants Location/Setting: Keneba, The Gambia, West Africa
Population: Not specified
Sample size: 385
Drop outs/withdrawal: Not specified
Socio‐demographics
Mean (SD) age: Not specified
Occupation: Not specified
Race: Not specified
Education: Not specified
Family income: Not specified
Inclusion criteria: All pregnant women in Keneba
Exclusion criteria: Twins were excluded
Interventions Intervention (sample size):
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):
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:
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:
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 Primary outcomes: None
Secondary outcomes:
Low birthweight
Small‐for‐gestational age
Birth weight
Timing of outcome assessment: Birth weights were recorded within 24 h of birth
Notes Study start date: 1976
Study end date: 1984
Time period: 8 years
Study country: The Gambia
Study limitations:
The authors used retrospective controls. Also, the effect on neonatal mortality cannot be assessed directly due to small numbers
Funding source: Not specified
Conflict of interest: Not specified