MISAME-3: Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Study Details
Study Description
Brief Summary
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation.
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth.
This research includes 2 phases:
-
Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement;
-
Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.
-
Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fortified BEP supplement Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement. |
Dietary Supplement: Fortified balanced energy-protein (BEP) supplement
The product contains the following target nutrients:
Total energy: 250-500 kcal per daily serving
Fat content: 10-60% of energy intake
Protein content: 16 g (range 14-18 g) with a Digestible Indispensable Amino Acid Score (DIAAS) of ≥ 0.9
Carbohydrate (CHO) Content: no specific recommendations, relative to fat and protein content.
Trans Fats: <1% energy intake Micronutrients include the following: A, D, E, K, B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9 (folate), B12 and C; minerals: iron, zinc, iodine, calcium, phosphorous, copper, and selenium.
The final composition of macro en micronutrients will be available after the acceptability testing (phase 1) and will be determined by 1) the product type and 2) the preferred taste.
|
| Active Comparator: Fe and folic acid Dietary Supplement: Fe and folic acid supplement. |
Dietary Supplement: Fe and folic acid supplement
Routine iron and folic acid supplementation.
|
Outcome Measures
Primary Outcome Measures
- Small-for-Gestational-age (SGA) [within 72h after birth]
Incidence of Small-for-Gestational-age (SGA) defined as <10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
- Length-for-age Z-scores (LAZ) [at 6 months (and 12 months on a subsample)]
Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
Secondary Outcome Measures
- Birth weight [within 72h after birth]
- Birth length [within 72h after birth]
- Chest circumference [within 72h after birth]
- Head circumference [within 72h after birth]
- Mid-upper arm circumference [within 72h after birth]
- Gestational age [at delivery]
- Preterm birth [at delivery]
Incidence of preterm birth at <37 weeks of gestation
- Large-for-gestational age [within 72h after birth]
Defined as a birth weight ≥90th centile intergrowth 21st reference
- Ponderal or Rohrer's index' [within 72 hours after birth]
Defined as birth weight/birth length3
- Fetal loss [during pregnancy]
Fetal death at <24 completed weeks of gestational age
- Stillbirths [during pregnancy]
Fetal death at ≥ 24 weeks gestational age
- Neonatal mortality [between birth and ≤ 28 days of life]
(1) Early neonatal mortality: deaths between birth and ≤ 7 days of life; (2) Neonatal mortality: deaths between birth and ≤28 days of life; (3) Late neonatal mortality deaths between >7 days and ≤28 days of life
- Prenatal weight gain [between study inclusion until just before delivery]
Weight change between study inclusion until just before delivery: total and trimester specific
- Gestational weight change [between study inclusion until 1 month after delivery]
Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
- Probable and possible maternal postnatal depression [(1) at 2 months of child age; (2) at 6 months of child age]
Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS>12. Possible depression is defined as EPDS>9 .
- Women's minimum and mean dietary diversity score [from study inclusion until delivery]
Measured biweekly using the 10 food group indicator as proposed by FAO. Minimum dietary diversity is defined as having consumed at least 5 food groups over the last 24 hours.
- Maternal anemia [at the third antenatal consultation]
Hemoglobin concentration <11g/dL
- Weight-for-Age Z-score [at 6 months of age]
WAZ, calculated using the WHO growth reference
- Weight-for-Length Z-score [at 6 months of age]
WLZ, calculated using the WHO growth reference
- Stunting [at 6 months of age]
Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference
- Wasting [at 6 months of age]
Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference
- Underweight [at 6 months of age]
Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference
- Incidence of child wasting [over first 6 months of life]
- Child weight gain [over first 6 months of life]
Monthly change in child weight
- Monthly change in LAZ [over first 6 months of life]
- Monthly change in WHZ [over first 6 months of life]
- Monthly change in WAZ [over first 6 months of life]
- Monthly change in head circumference [over first 6 months of life]
- Exclusive breastfeeding [during the first 6 months of life]
Duration of exclusive breastfeeding
- Child mortality [between birth and 6 months of age]
- Child morbidity symptoms [over first 6 months of life]
Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
- Child anemia [at 6 months of age]
Hemoglobin concentration <11g/dL
- Hemoglobin concentration [at 6 months of age]
- Infant body composition [first 3 months of life]
Sub-sample
- Maternal body composition [first 3 months after delivery]
Sub-sample
- Breast milk composition [between 1-2 and 3-4 months]
Sub-sample
- Relative average telomere length [At birth]
The umbilical cord blood will be analyzed to verify telomere length using qPCR on a sub-sample. Telomere lengths will be expressed as the ratio of telomere copy number to single-copy gene number (T/S) relative to the mean T/S ratio of the entire sample.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant age (15-40 years).
-
Pregnant as determined by a pregnancy test and confirmed by ultrasound.
-
Women who signed the informed consent form (in case of minors the parents or husband signs)
Exclusion Criteria:
-
Women planning to leave the area before delivery.
-
Women who plan to deliver outside the area.
-
Pregnancies with a gestational age > 20 weeks at study inclusion.
-
Women with multi-fetal gestation (exclusion from analysis).
-
Women who are allergic to peanuts.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Houndé district | Houndé | Tuy | Burkina Faso |
Sponsors and Collaborators
- University Ghent
- Harvard School of Public Health (HSPH)
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- AfricSanté, Burkina Faso
- International Food Policy Research Institute
- University of California, Davis
- Bill and Melinda Gates Foundation
Investigators
- Study Chair: Patrick Kolsteren, Prof. dr., University Ghent
- Study Director: Carl Lachat, Prof. dr., University Ghent
- Principal Investigator: Katrien W Vanslambrouck, MD, University Ghent
- Principal Investigator: Brenda PH de Kok, MSc., University Ghent
- Principal Investigator: Lieven F Huybregts, PhD, IFPRI
- Principal Investigator: Laeticia Celine Toe, MD MSc., IRSS
- Principal Investigator: Sheila Isanaka, Asst. Prof., Harvard School of Public Health (HSPH)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPP1175213