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

Maternal Exposure During Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136393
• Other study ID #: NFR-220895
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Maternal Exposure During Pregnancy

Intervention

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

Locations

Country	Name	City	State
Malawi	Monkey bay community hospital	Mangochi

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	London School of Hygiene and Tropical Medicine, University of Adelaide, University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

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