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

Not Applicable
Completed
Conditions
Maternal Exposure During Pregnancy
Interventions
Behavioral: Community based dietary counselling
Behavioral: Community based antenatal counselling
Registration Number
NCT03136393
Lead Sponsor
University of Oslo
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
300
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionCommunity based dietary counsellingCommunity based dietary counselling
ControlCommunity based antenatal counsellingCommunity based antenatal counselling
InterventionCommunity based antenatal counsellingCommunity based dietary counselling
Primary Outcome Measures
NameTimeMethod
Infant birthweight1 hour

Infant birthweight measured within an hour after birth

Secondary Outcome Measures
NameTimeMethod
Knowledge of healthy foodsAt 8-22 weeks; 35 weeks of gestation

Perceptions towards food, eating habits

Infant birth length1 hour

Infant birth length measured within an hour after birth

Infant birth abdomen circumference1 hour

Infant birth abdomen circumference measured within an hour after birth

Pregnancy skinfold thicknessAt 8-22 weeks; 35 weeks of gestation

Skinfold thicknesses (subscapular, biceps, triceps, suprailiac)

Pregnancy food intakeAt 8-22 weeks; 35 weeks of gestation

Quantified food intake past 24 hours

Pregnancy hemoglobin countAt 8-22 weeks; 35 weeks of gestation

Hemoglobin count in grams per decilitre

Infant birth head circumference1 hour

Infant head circumference measured within an hour after birth

Pregnancy body mass indexAt 8-22 weeks; 35 weeks of gestation

Weight, Height, during

Pregnancy blood glucose levelAt 8-22 weeks; 35 weeks of gestation

Blood glucose measured in milligram per decilitre

Trial Locations

Locations (1)

Monkey bay community hospital

🇲🇼

Mangochi, Malawi

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