Methods | Study design: Randomized controlled trial |
Unit of randomization: Individually randomised | |
Type of study: Food Distibution Program | |
Participants | Location/setting: Matlab, Chandipur district, Bangladesh. |
Population: Not specified | |
Sample size: 1041 | |
Drop outs/withdrawal: 259 | |
Socio‐demographics | |
Mean (SD) age: Total: 26.6 (5.7), Intervention: 26.7 (5.6) Control: 26.5 (5.8) | |
Occupation: Not specified | |
Race: Not specified | |
Education: Not specified | |
Family income: Not specified | |
Inclusion criteria: | |
Women (aged 14–50 years) in the study area (Matlab) with pregnancy confirmed by urine test and ultrasound with gestational age <14 weeks. The sample for this sub study was recruited from all eligible MINIMat participants who gave birth between June 2003 and March 2004 | |
Exclusion criteria: Not specified | |
Interventions | Intervention (sample size): |
Early Supplementation:The supplement contained rice, lentils, molasses and oil, contained 2.5 MJ per day, 6 days a week (29% of recommended energy intake), 25% of which was vegetable protein from 9 weeks of pregnancy to birth to 6 months postpartum. Intervention was delivered by community nutrition educators (n = 533) | |
Control (sample size): | |
Usual start of joining of government food supplementation. The supplement contained rice, lentils, molasses and oil, contained 2.5 MJ per day, 6 days a week (29% of recommended energy intake), 25% of which was vegetable protein. Duration of supplementation was from 20 weeks of pregnancy to birth to 6 months post partum. Intervention was delivered by community nutrition educators (n = 508) | |
Concomitant Interventions: | |
Each participant was also assigned to receive one of two counselling protocols from 30 weeks of gestation until 6 months after giving birth as follows: either usual health messages alone or usual health messages with exclusive breastfeeding counselling. Beginning at 14 weeks of gestation until 3 months post‐partum, each participant received one of three daily micronutrient supplements of either 60 mg or 30 mg of iron with 400 mg folic acid or multiple micronutrients | |
Training: | |
Community nutrition educators were trained by the implementing organisation, BRAC, to deliver nutrition education messages and to encourage women to consume food packets completely on site | |
Follow‐up: | |
Daily follow‐ups were conducted for salivary cortisol level monitoring but that is not relevant to our review. Measured cortisol from 28 to 32 weeks of gestation. Birth weight measured between one day of birth | |
Outcomes | Primary outcomes: None |
Secondary outcomes: | |
Low birthweight | |
Birth weight | |
Birth length | |
Head circumference | |
Timing of outcome assessment: Within one day of birth | |
Notes | Study start date: June 2003 |
Study end date: March 2004 | |
Time period: 9 months | |
Study country: Bangladesh | |
Study limitations: | |
Pregnant women could have partially or fully substituted the food packets for food at home, although the nutritional quality of food supplement may have been better than the food at home | |
Funding source: | |
Supported by the American Institute of Bangladesh Studies, Cornell Einaudi Center for International Studies, and NIH (training grant 5T32DK07158).The Maternal Infant Nutritional Interventions Matlab (MINIMat) research study was funded by United Nations Children's Fund, Swedish International Development Cooperation Agency (SIDA), UK Medical Research Council, Swedish Research Council, Department of International Development (DFID), International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Global Health Research Fund‐Japan, Child Health and Nutrition Research Initiative, Uppsala University and the United States Agency for International Development. Donors who provided unrestricted support to the Centre's research efforts: Australian International Development Agency, Government of Bangladesh, Canadian International Development Agency, Government of Japan, Government of Netherlands, SIDA, Swiss Development Cooperation and DFID |
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Conflict of interest: None |