Impact of a Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Reproductive Outcomes and Growth in Southern Nepal
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- George Washington University
- Enrollment
- 1,944
- Locations
- 1
- Primary Endpoint
- Small-for-Gestational-Age (<10th centile weight(g) for gestational age)
Study Overview
Brief Summary
This project will test the efficacy of a balanced protein energy supplement for daily use during pregnancy and the first 6 months after delivery on the outcomes of pregnancy and growth of infants during the first 6 months of life. Approximately 1800 pregnant women from a district in southern Nepal will be recruited and randomly assigned to one of 4 groups, control in pregnancy & post-partum, supplementation in pregnancy & control post-partum, control in pregnancy & supplementation post-partum, or supplementation in pregnancy & post-partum. Pregnancies will be followed until delivery and the infants through 6 months of age. Outcomes of interest include birth size (weight and length), gestational age at delivery, maternal weight gain in pregnancy, maternal weight at 6 months post-partum, infant growth, and breast milk composition.
Detailed Description
Background Undernourished women in many low and middle income countries (LMICs) enter pregnancy with low nutritional reserves, and low maternal body mass index (BMI) and short stature are associated with increased risks of a variety of adverse reproductive outcomes (Kozuki et al., 2015; Rahman et al., 2015). Balanced protein-energy (BE-P) supplementation during pregnancy shows moderate evidence than such dietary supplementation can decrease the risk of stillbirth and small-for-gestational-age (SGA) births (Ota et al., 2015; Stevens et al., 2015). The WHO antenatal care guidelines recommend providing pregnant women in undernourished populations with balanced protein energy dietary supplementation (WHO, 2016). The current evidence base for BP-E supplementation draws from a number of studies where BP-E supplements varied widely in composition and form (Imad & Bhutta, 2002). Recent studies using fortified blended foods found that although approximately 800 kcal/d was provided, the net energy intake increased by a much smaller amount (200-300 kcal) (Janmohamed et al., 2016; Saville et al., unpublished trial in Nepal).
Evidence regarding dietary practices and preferences among pregnant women in Nepal is generally limited, however, some studies have shown that intra-household food allocation and specific food beliefs/behaviors do not favor adequate energy or micronutrient intake among adolescent girls and adult women (Gittelsohn, 1991; Gittelsohn et al., 1997). Christian et al showed that staple food intake can be reduced during pregnancy; which could be attributed to an aversion to food, lack of appetite, feeling unwell, or concern regarding having a "large" baby and difficulties with labor and delivery (Christian et al., 2006). Low nutrition knowledge may also play a role in suboptimal intake among women (Jones et al., 2005). Dynamic changes in access and use of services offer the opportunity to nest additional nutritional support services within the antenatal care system, including BP-E supplementation. However, information is limited regarding the impact such supplementation will have on the key birth outcomes that affect child health and development. It is this lack of evidence that this project will address.
Methods This project will be done in three phases. Phase one will identify preferable supplement types for use in pregnancy in the South Asian context. Phase two will use the results of phase one to conduct a medium-term feeding trial to assess acceptability and consumption. Phase three will be a large, community-based randomized trial using at least one of these supplement options for use in pregnancy and through the first 6 months post-partum on birth outcomes and early infant growth.
Specific Aim, Phase 1: Identify preferred product types for the provision of fortified BEP supplements among pregnant women in Southern Nepal.
Specific Aim, Phase 2: Assess the 8-week acceptability and consumption of 2 selected supplements with nutrient content consistent with Bill and Melinda Gates Foundation (BMGF) guidance among pregnant women in Southern Nepal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 30 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •all women who become pregnant during an approximate 6-month period in two cohorts in a set of Nagarpalikas and Gaunpalikas in Sarlahi District, Nepal.
Exclusion Criteria
- •Women who do not intend to deliver their child in the study area.
- •Women who are allergic to milk, nuts or soy.
- •Women who are unwilling to commit to daily consumption of the nutritional supplement if they are randomized to an active treatment arm.
- •Women who refuse to provide consent.
Outcomes
Primary Outcomes
Small-for-Gestational-Age (<10th centile weight(g) for gestational age)
Time Frame: Within 72 hours of birth.
The incidence of SGA (\<10th centile) among live born infants whose birth weight(g) is measured within 72 hours of delivery. Comparison is between those supplemented during pregnancy versus those not.
Length-for-Age Z scores
Time Frame: 6 months of age
Mean Length(cm)-for-age Z score among infants at 6 months of age. Comparison is between women supplemented during post-partum period versus those not.
Secondary Outcomes
- Short-for-Gestational-Age (<10th centile height(cm) for gestational age)(Within 72 hours of birth.)
- Small-for-Gestational-Age (<3rd centile weight(g) for gestational age)(Within 72 hours of birth.)
- Short-for-Gestational-Age (<3rd centile height(cm) for gestational age)(Within 72 hours of birth.)
- Gestational age(Birth)
- Birth weight(Within 72 hours of birth.)
- Birth Length(Within 72 hours of birth.)
- Low birth weight (<2500 g)(Within 72 hours of birth.)
- Proportion preterm (<37 weeks)(Birth)
- Prevalence of wasting(6 & 12 months of age.)
- Gestational Weight Gain(From enrollment to the late pregnancy visit (34-36 weeks gestation).)
- Prevalence of stunting(6 and 12 months of age.)
- Weight-for-age(6 & 12 months of age.)
- Maternal weight (kg).(Late pregnancy visit (~ 36 weeks) & 6 months post-partum.)
- Prevalence of underweight(6 & 12 months of age.)
- Weight-for-length(6 & 12 months of age.)
- Maternal Body Mass Index (BMI)(Late pregnancy visit (~ 36 weeks) & 6 months post-partum.)
- Microbiome Diversity - Mothers(Baseline enrollment, mid-2nd trimester, late pregnancy, 1-2 months post-partum, and 3-4 months post-partum)
- Microbiome Diversity - Infants(1-2 months of age and 3-4 months of age.)
Investigators
James M. Tielsch, PhD
Professor and Chair School of Public Health, PI
George Washington University