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

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.

Study Overview

• Status: Completed
• Conditions: Maternal Exposure During Pregnancy
• Intervention / Treatment: Behavioral: Community based antenatal counselling; Behavioral: Community based dietary counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Mangochi, Malawi
    • Monkey bay community hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: London School of Hygiene and Tropical Medicine; University of Adelaide; University of Malawi
• Investigators: Principal Investigator: Penjani R Kamudoni, PhD, University of Oslo

Publications and helpful links

General Publications

• Katenga-Kaunda LZ, Iversen PO, Kamudoni PR, Holmboe-Ottesen G, Fjeld HE. Food-based nutrition counselling and education intervention for improved diets of pregnant women in rural Malawi: a qualitative study of factors influencing dietary behaviour change. Public Health Nutr. 2022 Sep;25(9):2436-2447. doi: 10.1017/S1368980022000593. Epub 2022 Apr 4.
• Katenga-Kaunda LZ, Kamudoni PR, Holmboe-Ottesen G, Fjeld HE, Mdala I, Shi Z, Iversen PO. Enhancing nutrition knowledge and dietary diversity among rural pregnant women in Malawi: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Sep 22;21(1):644. doi: 10.1186/s12884-021-04117-5.
• Ziyenda Katenga-Kaunda L, Iversen PO, Holmboe-Ottesen G, Fjeld H, Mdala I, Kamudoni PR. Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial. Public Health Nutr. 2020 Sep;23(13):2345-2354. doi: 10.1017/S1368980020000294. Epub 2020 May 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): April 12, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 5, 2016
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: nutrition; pregnancy; birth weight
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: NFR-220895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED