Methods
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Study design: Randomized controlled trial |
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Unit of randomization: Individually randomised |
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Type of study: Balanced Energy Protein |
Participants
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Location/setting: Metabolic ward of St. John's Research Institute, Bangalore, India |
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Population: Not specified |
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Sample size: 24 |
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Drop outs/withdrawal: None |
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Socio‐demographics
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Mean (SD) age: Total: 22.9 (3.24), Intervention: 23.7 (4.1), Control: 22.2 (1.99) |
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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:
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Only pregnant women from the same dwelling area and similar socioeconomic background were invited to join the study. Pregnant women at <13 weeks of gestation with low BMIs (≤18.5) and normal plasma folate and vitamin B‐12 status were identified and invited |
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Exclusion criteria:
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Women with multiple pregnancies, those with a clinical diagnosis of chronic illness (e.g., diabetes mellitus, hypertension, cardiac disease, thyroid disease, or epilepsy), and those who tested positive for hepatitis B surface antigen, HIV, or syphilis were excluded |
Interventions
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Intervention (sample size):
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In addition to their normal habitual diet, the supplemented group received a daily dietary supplement of 300 kcal/day energy and 15 g protein/day (i.e., 20% of energy from protein), provided as 3 small, round granola‐type treats, called “ladoos“ in the local language, and made of crushed roasted peanuts, puffed rice, skimmed milk, clarified butter, and unrefined sugar from 1st trimester till delivery. Intervention was delivered by a social worker (n = 12) |
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Control (sample size):
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No supplementation. The control group continued to consume their habitual diet. It was delivered by a social worker |
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(n = 12) |
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Training: Not specified |
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Follow‐up:
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Protein kinetics and serine and glycine fluxes were measured by using standard stable isotope tracer methods in the fasting and postprandial state at end of 1st and beginning of 3rd trimester. 24‐h food recalls were obtained three times during each trimester of pregnancy |
Outcomes
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Primary outcomes: Miscarriage |
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Secondary outcomes:
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Low birthweight |
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Preterm birth |
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Small‐for‐gestational age |
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Birth weight |
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Birth length |
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Timing of outcome assessment: At birth |
Notes
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Study start date: Not specified |
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Study end date: Not specified |
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Time period: Not specified |
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Study country: India |
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Study limitations: The sample size was relatively small. |
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Funding source:
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Supported by federal funds from the USDA, Agricultural Research Service, under Cooperative Agreement 58‐6250‐6001 |
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Conflict of interest: None |