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. 2021 Jun 21;17(2):e1150. doi: 10.1002/cl2.1150
Methods Study design: Randomized controlled trial
Unit of randomization: Individually randomised
Type of study: Balanced Energy Program
Participants Location/setting: Health care centres of Ghaemieh and Baghfayz, Iran
Population: Not specified
Sample size: 53
Drop outs/withdrawal: Not specified
Socio‐demographics
Mean (SD) age:
Supplemented: 26.3 (6)
Control: 25.5 (7)
Occupation: Not specified
Race: Not specified
Education: Not specified
Family income: Not specified
Inclusion criteria:
Healthy pregnant women who were free from systemic and genetic disorders and without a history of stillbirth, premature birth, or low birth weight infants
Exclusion criteria: Using medication or addicted to illicit drugs were excluded
Interventions Intervention (sample size):
Traditional Food Supplementation: The experimental group received traditional food supplementation everyday, supplying an extra 400 kcal and 15 g protein through the Ghaemiah health care centre. Food supplementation which included rice‐milk porridge, lentils, pottage, cheese, yogurt, eggs and milk with bread, was given five days during the week. It was provided from 4th month of pregnancy until childbirth (n = 28)
Control (sample size): Unsupplemented (n = 25)
Concomitant interventions: Prenatal care
Training: Not specified
Follow‐up:
Mothers were weighed once a month throughout pregnancy and 24‐h recall was used to estimate food intake. Infants were followed monthly until 4 months of age
Outcomes Primary outcomes: None
Secondary outcomes: Birth weight
Timing of outcome assessment: At birth
Notes Study start date: Not specified
Study end date: Not specified
Time period: Not specified
Study country: Iran
Study limitations: Not specified
Funding source: Not specified
Conflict of interest: Not specified