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

NCT03136393 | Completed

• 1 other identifier: NFR-220895
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Exposure During Pregnancy

Keywords

nutrition; pregnancy; birth weight

Outcome Measures

Primary Outcomes (1)

• Infant birthweight

  Infant birthweight measured within an hour after birth

  1 hour

Secondary Outcomes (9)

• Infant birth length

  1 hour

• Infant birth head circumference

  1 hour

• Infant birth abdomen circumference

  1 hour

• Pregnancy body mass index

  At 8-22 weeks; 35 weeks of gestation

• Pregnancy blood glucose level

  At 8-22 weeks; 35 weeks of gestation

Study Arms (2)

Control

ACTIVE COMPARATOR

Community based antenatal counselling

Behavioral: Community based antenatal counselling

Intervention

EXPERIMENTAL

Community based dietary counselling

Behavioral: Community based dietary counselling; Behavioral: Community based antenatal counselling

Interventions

Community based dietary counselling BEHAVIORAL

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.

Intervention

Community based antenatal counselling BEHAVIORAL

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

Control; Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe illness, where the mother is bed ridden
• Multiple births

Sponsors & Collaborators

• University of Oslo: lead
• University of Malawi: collaborator
• University of Adelaide: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Monkey bay community hospital

Mangochi, Malawi

Location

Related Publications (4)

• Kamudoni PR, Kaunda L, Tharrey M, Mphande M, Chithambo S, Ferguson E, Shi Z, Mdala I, Maleta K, Munthali A, Holmboe-Ottesen G, Iversen PO. Context-Tailored Food-Based Nutrition Education and Counseling for Pregnant Women to Improve Birth Outcomes: A Cluster-Randomized Controlled Trial in Rural Malawi. Curr Dev Nutr. 2024 Nov 7;8(12):104506. doi: 10.1016/j.cdnut.2024.104506. eCollection 2024 Dec.

  PMID: 39654971 DERIVED

• 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.

  PMID: 35369896 DERIVED

• 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.

  PMID: 34551744 DERIVED

• 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.

  PMID: 32419688 DERIVED

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Penjani R Kamudoni, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: May 2, 2017
• Study Start: November 1, 2015
• Primary Completion: April 12, 2017
• Study Completion: December 31, 2017
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

MA (1)