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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: Food Distribution Program
Participants Location/setting: Farming communities of West Kiang region, Gambia
Population: 15 000
Sample size: 620
Drop outs/withdrawal: The exclusions were due to missing birth weight data (N = 129)
Socio‐demographics
Median (SD) age:
Intervention: 29.8
Control: 30
Age range: 18–45 years
Occupation: Farming
Race: Not specified
Education: Not specified
Family income: Not specified
Inclusion criteria:
Women confirmed as being between 10 and 20 weeks pregnant by ultrasound
Nonpregnant women of reproductive age (18–45 years)
Exclusion criteria:
Women who were
  • (i)

    currently pregnant (beyond 20 weeks on ultrasound assessment),

  • (ii)

    currently enrolled in another MRC study,

  • (iii)

    severely anaemic at booking (haemoglobin (Hb) <7 g/dl), or

  • (iv)

    report the onset of menopause were excluded from entry into the trial

Interventions Intervention (sample size):
Protein Energy (PE) provided with 746 kcal/day of energy from protein and lipids. It was provided to pregnant women between 10‐20th week of gestation. LNS was distributed on a weekly basis to participating women. LNS were supplied in jars, with a single (daily) dose per jar. It was provided through field workers and midwives (n = 151)
Control (sample size):
FeFol (iron 60 mg/day and folic acid 400 μg/day) was given as a prenatal care. It was provided to pregnant women between 10‐20th week of gestation. It was provided through field workers and midwives. Supplementation commenced the following week, receiving daily tablet supplements. Both supplement types (tablets and LNS) were distributed on a weekly basis to participating women. Women were supplied with 14 tablets per week in individual bottles and advised to take two tablets per day, preferably with food (n = 146)
Concomitant interventions: Not specified
Training:
Prior to the start of the study, two sonographers were trained in fetal biometry
Follow‐up:
Subsequent clinic visits were made at 20 and 30 weeks of gestation, and a home visit performed within 72 h of birth
Outcomes Primary outcomes: None
Secondary outcomes:
Low birthweight
Preterm birth
Small for gestational age
Timing of outcome assessment: At birth
Notes Study start date: January 2010
Study end date: February 2014
Time period: 4 years
Study country: Gambia
Study limitations:
This was a post‐hoc analysis with a sample size that was not powered on the outcomes or for the subgroup analyses. Other limitations include not having a maternal weight measure at the very end of gestation, which would have allowed the author to quantify weight gain throughout the final trimester, and not necessarily being able to generalize results to other populations
Funding source:
This trial was supported by the UK Medical Research Council (MRC) (MC‐A760‐5QX00) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement. WJ and SEM are funded by the UK MRC programme MC_UP_1005/1
Conflict of interest: None