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Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Mangochi , Malawi

A Protocol for a Cluster Randomized Controlled Trial Measuring the Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Nankumba, Mangochi District, Malawi

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03136393
Enrollment
300
Registered
2017-05-02
Start date
2015-11-01
Completion date
2017-12-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Exposure During Pregnancy

Keywords

nutrition, pregnancy, birth weight

Brief summary

High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and has thus been a hindrance for Malawi to eradicate child deaths. From 2000 to 2011, Malawi achieved an overall reduction of 23% in under-five child mortality. The reduction was more substantial between the second and the fifth year of life, being 28%. However, in the neonatal period the reduction was half, at 14%. Neonatal deaths in developing countries are due to prematurity or low birth weight, neonatal infections, birth trauma related conditions and congenital anomalies. Being of low birth weight increases the risk of death four fold in the neonatal period. Even when low birth weight infants survive, their poorly developed immune function exposes them to increased morbidity in early life. Maternal nutrition represents by far the greatest influence among pregnancy environmental on birth weight in low income countries. There is strong evidence that health and dietary counselling is effective in improving child nutrition outcomes. Thus we propose to test the effectiveness in improving birth weight by a low cost intervention, community based health and nutrition counselling delivered to mothers during pregnancy in Malawi. On the other hand, in the Malawian context offering individualized dietetic counselling could be impeded by the healthcare workforce short fall. Currently the health workforce does not include dieticians . The use of lay health workers (LHW) has been identified as one of the effective strategies to meet the health workforce shortage challenges in low resource settings. It is on this basis that a study was planned, aimed at developing lay health worker delivered community based nutrition counselling to mothers during pregnancy and measuring its effectiveness in improving birth weight in the Malawian context. The study was comprised of an initial i) formative study, followed by ii) a cross-sectional survey. Findings of these two sub-studies were utilized to develop a nutrition counselling intervention. Finally iii) a cluster Randomized Controlled Trial (cRCT) aimed at measuring the effect of the intervention on birth size (weight, length, arm and abdominal circumferences) will now be conducted which is being elaborated in this protocol.

Detailed description

High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and has thus been a hindrance for Malawi to eradicate child deaths. From 2000 to 2011, Malawi achieved an overall reduction of 23% in under-five child mortality. The reduction was more substantial between the second and the fifth year of life, being 28%. However, in the neonatal period the reduction was half, at 14%. Neonatal deaths in developing countries are due to prematurity or low birth weight, neonatal infections, birth trauma related conditions and congenital anomalies. Being of low birth weight increases the risk of death four fold in the neonatal period. Even when low birth weight infants survive, their poorly developed immune function exposes them to increased morbidity in early life. Maternal nutrition represents by far the greatest influence among pregnancy environmental on birth weight in low income countries. There is strong evidence that health and dietary counselling is effective in improving child nutrition outcomes. Thus we propose to test the effectiveness in improving birth weight by a low cost intervention, community based health and nutrition counselling delivered to mothers during pregnancy in Malawi. On the other hand, in the Malawian context offering individualized dietetic counselling could be impeded by the healthcare workforce short fall. Currently the health workforce does not include dieticians . The use of lay health workers (LHW) has been identified as one of the effective strategies to meet the health workforce shortage challenges in low resource settings. It is on this basis that a study was planned, aimed at developing lay health worker delivered community based nutrition counselling to mothers during pregnancy and measuring its effectiveness in improving birth weight in the Malawian context. The study was comprised of an initial i) formative study, followed by ii) a cross-sectional survey. Findings of these two sub-studies were utilized to develop a nutrition counselling intervention. Finally iii) a cluster Randomized Controlled Trial (cRCT) aimed at measuring the effect of the intervention on birth size (weight, length, arm and abdominal circumferences) will now be conducted which is being elaborated in this protocol. Three hundred pregnant women, at ≥12 weeks but ≤ 16 weeks of gestation, will be recruited from Nankumba Traditional Authority (TA) area, in Mangochi district. They will be offered community based dietary counselling aiming at improving dietary intake to meet their nutritional needs. Measurement of study outcomes will be as follows: Infant birthweight will be collected at the end of the study while as dietary intake (including dietary perceptions), anthropometric status, and biochemical nutrition status will be assessed at enrollment, and two additional time points before the end point.

Interventions

BEHAVIORALCommunity based dietary counselling

The dietary counseling will be delivered to mothers through group sessions (will include cooking demonstration) and home visits by lay health workers. The counseling will promote foods that are nutritious and locally available and general better food preparation practices. The choices of the foods to be promoted will be based on linear programming results from a preceding survey on dietary intake of pregnant women in the area as well as results of analysis of foods associated with infant birth size (same data). The goal in the linear programming was to find a model of food combinations among the most frequently consumed foods which better meets required intakes during pregnancy. Additionally, adherence to pregnancy iron supplements will also be promoted.

BEHAVIORALCommunity based antenatal counselling

The antenatal counselling will focus on preparations for neonatal care and encouragement for facility based delivery.

Sponsors

University of Malawi
CollaboratorOTHER
University of Adelaide
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

1. Pregnant at ≥ 6 weeks but ≤ 17 weeks of gestation 2. Available during the period of the study. 3. Intention to reside in the study area in the next 6 months 4. Intention to give birth at the health facilities within the study area 5. Consent to participate (indicated by a signature or fingerprint)

Exclusion criteria

1. Severe illness, where the mother is bed ridden 2. Multiple births

Design outcomes

Primary

MeasureTime frameDescription
Infant birthweight1 hourInfant birthweight measured within an hour after birth

Secondary

MeasureTime frameDescription
Infant birth head circumference1 hourInfant head circumference measured within an hour after birth
Infant birth abdomen circumference1 hourInfant birth abdomen circumference measured within an hour after birth
Pregnancy body mass indexAt 8-22 weeks; 35 weeks of gestationWeight, Height, during
Pregnancy blood glucose levelAt 8-22 weeks; 35 weeks of gestationBlood glucose measured in milligram per decilitre
Infant birth length1 hourInfant birth length measured within an hour after birth
Pregnancy skinfold thicknessAt 8-22 weeks; 35 weeks of gestationSkinfold thicknesses (subscapular, biceps, triceps, suprailiac)
Pregnancy food intakeAt 8-22 weeks; 35 weeks of gestationQuantified food intake past 24 hours
Knowledge of healthy foodsAt 8-22 weeks; 35 weeks of gestationPerceptions towards food, eating habits
Pregnancy hemoglobin countAt 8-22 weeks; 35 weeks of gestationHemoglobin count in grams per decilitre

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026