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Background:
Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy and during first two years of child's life in different bundles will cause a shift of 0.4 in mean LAZ score among children at 24 months of age compared to those in comparison arm.
Methods: The investigators propose a community-based randomized trial (cRCT) to evaluate the effectiveness of different combinations of the five selected nutrition-specific interventions and identify the best combination for improving childhood LAZ. Selected interventions include prenatal nutrient supplementation; intensive counselling on prenatal nutrition, exclusive breastfeeding and timely complementary feeding; and nutrient supplementation during 6-23 months of child's age. The proposed study area is Habiganj district, Sylhet division. 125 clusters (each ~2000 population or ~450 households) will be selected from 12 homogeneous unions in 2 adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study arms. Data would be collected at baseline and followed up, including on nutritional intake and anthropometric measurements of mothers and offspring. Primary outcome measure/variable would be mean LAZ of offspring at 24 months. Secondary outcome variables include nutritional intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and birth weight.
Implications: The investigators expect that the results will serve to inform and shape future health policy decisions related to promotion of maternal and child health.
Full description
Research Design and Methods
The investigators propose a community-based cluster randomized trial (cRCT) to evaluate the effectiveness of different combinations of 5 selected prenatal and post-natal nutrition-specific interventions in improving mean LAZ scores among 24 months old children. The interventions to be tested in different combinations are-:
The cohort of pregnant women and their children from that pregnancy will be followed-up over 32 months of the intervention period.
Sample Size Calculation
Power-based sample size estimation procedure was adopted. Assumptions used in sample size calculation include:
Study setting The study will be conducted in the Habiganj district, Sylhet division for the reported highest stunting prevalence in Bangladesh. The investigators will select 12 Unions (population ~300,000) randomly from two adjacent sub-districts. Each Union would be divided into clusters, each cluster comprising of ~450 households or ~2000 population. In selected 125 study clusters, 10 and 20 pregnant women in each intervention and comparison cluster would be enrolled, respectively, and enrolment would be closed accordingly. Considering estimated live births per year at 21/1000 population, expected number of 24 months old children from each cluster by study completion would be 7, after adjusting for 4.5% mortality in postnatal two years and 30% drop-out. Thus, 25 clusters per study arm would yield 175 and 350 children per intervention comparison arms, respectively, reaching their second birthday, the required number of samples for the trial.
Treatment assignment The investigators will randomly select 5 clusters or multiples of 5 clusters per union, 125 clusters in total, by a computer assisted programme. In each union, the selected clusters will be evenly allocated to the 5 study arms, specified by a random allocation sequence generated by a computer assisted programme.
Recruitment of participants Pregnant women in the study area would be listed through a door-to-door surveillance conducted fortnightly. From them, those within 125 gestational age would be voluntarily enrolled into the study upon confirmation by pregnancy strip tests.
Post-enrolment study procedure:
After enrolment, two teams would be active: 1) The intervention team in intervention arms (arms 1, 2, 3 and 4); and 2) The assessment team in all 5 arms. Both teams would be supervised and monitored by two layers of field supervisors.
Project Management Information System (MIS) A comprehensive automated project MIS will be developed through web linked tablet-PC-based pregnancy enrolment, data collection and intervention delivery format. The android-based customised platform will direct the CHWs and enrolment DCs of their intervention and data collection visit schedules, respectively, and will also contain the BCC modules and the questionnaires as required.
Data collection All data collection tools are adopted from standard validated structured questionnaire, especially from BDHS. Key indicators to be reported and tools to be used are showed in table 2.
All measurement equipment would be calibrated before each use.
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2,880 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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