NCT03136393

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

Completed NA Last updated 18 June 2023

What this trial tests

NA trial testing Community based dietary counselling in Maternal Exposure During Pregnancy in 300 participants. Completed in 31 December 2017.

Timeline

1 November 2015

Primary endpoint
12 April 2017

31 December 2017

Quick facts

Lead sponsor	University of Oslo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	300
Start date	1 November 2015
Primary completion	12 April 2017
Estimated completion	31 December 2017
Sites	1 location across Malawi

Drugs / interventions tested

• Community based dietary counselling
• Community based antenatal counselling

Conditions studied

• Maternal Exposure During Pregnancy — all drugs for Maternal Exposure During Pregnancy →

Sponsor

University of Oslo

Who can join

Eligibility, female only, with Maternal Exposure During Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing nutrition knowledge and dietary diversity among rural pregnant women in Malawi: a randomized controlled trial.
   Katenga-Kaunda LZ, Kamudoni PR, Holmboe-Ottesen G, Fjeld HE, et al · · 2021 · cited 28× · PMID 34551744 · DOI 10.1186/s12884-021-04117-5
2. Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.
   Ziyenda Katenga-Kaunda L, Iversen PO, Holmboe-Ottesen G, Fjeld H, et al · · 2020 · cited 15× · PMID 32419688 · DOI 10.1017/s1368980020000294
3. 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.
   Katenga-Kaunda LZ, Iversen PO, Kamudoni PR, Holmboe-Ottesen G, et al · · 2022 · cited 9× · PMID 35369896 · DOI 10.1017/s1368980022000593
4. Context-Tailored Food-Based Nutrition Education and Counseling for Pregnant Women to Improve Birth Outcomes: A Cluster-Randomized Controlled Trial in Rural Malawi.
   Kamudoni PR, Kaunda L, Tharrey M, Mphande M, et al · · 2024 · cited 2× · PMID 39654971 · DOI 10.1016/j.cdnut.2024.104506