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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Exposure During Pregnancy

Intervention / Treatment
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* Behavioral: Community based dietary counselling
* Behavioral: Community based antenatal counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant at ≥ 6 weeks but ≤ 17 weeks of gestation Available during the period of the study. Intention to reside in the study area in the next 6 months Intention to give birth at the health facilities within the study area Consent to participate (indicated by a signature or fingerprint) Exclusion Criteria: Severe illness, where the mother is bed ridden Multiple births
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Community based antenatal counselling | Behavioral: Community based antenatal counselling<br>* The antenatal counselling will focus on preparations for neonatal care and encouragement for facility based delivery.<br>|
| Experimental: Intervention<br>Community based dietary counselling | Behavioral: Community based dietary counselling<br>* 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.<br>Behavioral: Community based antenatal counselling<br>* The antenatal counselling will focus on preparations for neonatal care and encouragement for facility based delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birthweight | Infant birthweight measured within an hour after birth | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birth length | Infant birth length measured within an hour after birth | 1 hour | 
| Infant birth head circumference | Infant head circumference measured within an hour after birth | 1 hour | 
| Infant birth abdomen circumference | Infant birth abdomen circumference measured within an hour after birth | 1 hour | 
| Pregnancy body mass index | Weight, Height, during | At 8-22 weeks; 35 weeks of gestation | 
| Pregnancy blood glucose level | Blood glucose measured in milligram per decilitre | At 8-22 weeks; 35 weeks of gestation | 
| Pregnancy hemoglobin count | Hemoglobin count in grams per decilitre | At 8-22 weeks; 35 weeks of gestation | 
| Pregnancy skinfold thickness | Skinfold thicknesses (subscapular, biceps, triceps, suprailiac) | At 8-22 weeks; 35 weeks of gestation | 
| Pregnancy food intake | Quantified food intake past 24 hours | At 8-22 weeks; 35 weeks of gestation | 
| Knowledge of healthy foods | Perceptions towards food, eating habits | At 8-22 weeks; 35 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, pregnancy, birth weight