Methods
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Study design: Cluster‐randomised controlled trial |
Unit of randomization: Cluster‐randomised |
Type of study: Food Program |
Participants
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Location/setting: 11 rural unions of the Badarganj and Chirirbandar subdistricts of 2 northwest districts of Bangladesh (Rangpur and Dinajpur), 340 km from Dhaka, Bangladesh |
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Population: 279,614 |
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Sample size: 4011 |
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Drop outs/withdrawal: |
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One maternal death during pregnancy (in the IFA group), and 93 mothers were lost to follow‐up (22 in the LNS‐PL group and 71 in the IFA group) |
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Socio‐demographics
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Mean (SD) age:
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Intervention: 21.8 (4.9) |
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Control: 22 (5) |
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Occupation: Transportation, construction and petty trading. |
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Race: Not specified |
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Education:
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Years of formal education (Mean): |
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LNS‐PL: 6.4 |
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IFA: 6.1 |
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Family income: Not specified |
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Inclusion criteria:
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Gestational age to be 20 weeks and no plans to move out of the study area during pregnancy or the following 3 y (i.e., a permanent resident of the study area). |
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Exclusion criteria: Pregnancy identified and registered in the CHDP program before the beginning of enrolment |
Interventions
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Intervention (sample size):
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(1) Comprehensive LNS group (LNS‐PL): |
women received LNS‐PL throughout pregnancy and post partum for 6 months. |
Women received LNS‐PL (LNSs for pregnant and lactating women) during pregnancy and the first 6 months postpartum. Ingredients included soybean oil, powdered milk, peanut paste, sugar, and multiple micronutrients (thiamin, riboflavin, niacin, vitamin B‐6, vitamin B‐12, vitamin D, vitamin E, zinc, copper, and selenium at twice the amount as previously used UNIMAPP formulations), LNS‐PL was produced in individual 20‐g sachets (LNS was 20 g/day 118 kcal per day).The intervention was delivered by LAMB‐CHDP community health workers |
(n = 1047) |
Control (sample size):
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(1) Control group in which women were given IFA once daily during pregnancy and once every other day for 3 months post partum period |
(2) Child‐only LNS group: |
women received 1 tablet of 60 mg Fe and 400 mg folic acid/d during pregnancy and every alternate day during the first 3 months postpartum and their children received LNS‐C from the ages of 6–24 months |
(3) Child‐only micronutrient group: |
Women received IFA daily during pregnancy and every alternate day during the first 3 months postpartum and their children received micronutrient powder from the ages of 6 to 24 months |
The three groups of women who received IFA during pregnancy were combined and compared with the “comprehensive LNS” arm for the analysis of birth outcomes. The supplements in control group were delivered by LAMB‐CHDP community health workers and village health volunteers (VHVs) |
(n = 2964) |
Concomitant interventions:
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Monthly, the CHWs and VHVs would set classes for the discussion of child health and maternal health topics |
Trainings:
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Anthropometrists were trained and methods were standardized at the beginning of data collection and thereafter periodically by using methods described by (WHO MGRS) |
Follow‐up:
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Monthly follow‐up visits by the CHW to the woman's home. Follow‐up during pregnancy included a home visit (at 35 weeks) by the home visit team to collect data on diet and birth preparedness and a subsequent safe delivery unit (SDU) visit at 36 week (wk) for anthropometry and to assess depressive symptoms and collect bio specimens by the SDU visit team |
After delivery, the study protocol required that each woman be visited within 72 h after birth. Each woman was also called at 28 weeks of gestation and every week from 36 weeks of gestation until the delivery occurred. Retrospective data on adherence to supplement use recommendations during pregnancy were collected at a later home visit at 6 week postpartum |
Outcomes
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Primary outcomes:
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Miscarriage |
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Stillbirth |
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Perinatal mortality |
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Secondary outcomes:
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Maternal mortality |
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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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Head circumference |
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Stunting |
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Wasting |
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Underweight |
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Timing of outcome assessment: At delivery |
Notes
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Study start date: October 2011 |
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Study end date: October 2015 |
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Time period: 4 years |
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Study country: Bangladesh |
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Study limitations:
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The disruption of LNS‐PL supply for a period of 10 weeks, compromised the ability to investigate the full potential of LNS‐PL as an intervention. Second, it was not possible to blind the women to the type of supplement provided because the supplements were very different in appearance and taste. Third, they used LMP to estimate the duration of gestation, because it was not feasible to use ultrasonography for all participants. Fourthly, they relied on the women's retrospective recollection of supplement consumption to assess adherence instead of direct observation, so the adherence data could be inaccurate. Finally, they examined effects within several different targeted subgroups, and these exploratory effect modification results need to be interpreted with caution because they examined multiple hypotheses and the study was not powered to test each potential interaction |
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Funding source:
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US Agency for International development's Food and Nutrition Technical Assistance III Project (FANTA), managed by Family Health International 360 |
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Conflict of interest: None |