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

Primary Purpose

Maternal Exposure During Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Community based dietary counselling
Community based antenatal counselling
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Exposure During Pregnancy focused on measuring nutrition, pregnancy, birth weight

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Monkey bay community hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Community based antenatal counselling

Community based dietary counselling

Outcomes

Primary Outcome Measures

Infant birthweight
Infant birthweight measured within an hour after birth

Secondary Outcome Measures

Infant birth length
Infant birth length measured within an hour after birth
Infant birth head circumference
Infant head circumference measured within an hour after birth
Infant birth abdomen circumference
Infant birth abdomen circumference measured within an hour after birth
Pregnancy body mass index
Weight, Height, during
Pregnancy blood glucose level
Blood glucose measured in milligram per decilitre
Pregnancy hemoglobin count
Hemoglobin count in grams per decilitre
Pregnancy skinfold thickness
Skinfold thicknesses (subscapular, biceps, triceps, suprailiac)
Pregnancy food intake
Quantified food intake past 24 hours
Knowledge of healthy foods
Perceptions towards food, eating habits

Full Information

First Posted
March 5, 2016
Last Updated
June 15, 2023
Sponsor
University of Oslo
Collaborators
University of Malawi, University of Adelaide, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03136393
Brief Title
Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Mangochi , Malawi
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
University of Malawi, University of Adelaide, London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Exposure During Pregnancy
Keywords
nutrition, pregnancy, birth weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Community based antenatal counselling
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Community based dietary counselling
Intervention Type
Behavioral
Intervention Name(s)
Community based dietary counselling
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Community based antenatal counselling
Intervention Description
The antenatal counselling will focus on preparations for neonatal care and encouragement for facility based delivery.
Primary Outcome Measure Information:
Title
Infant birthweight
Description
Infant birthweight measured within an hour after birth
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Infant birth length
Description
Infant birth length measured within an hour after birth
Time Frame
1 hour
Title
Infant birth head circumference
Description
Infant head circumference measured within an hour after birth
Time Frame
1 hour
Title
Infant birth abdomen circumference
Description
Infant birth abdomen circumference measured within an hour after birth
Time Frame
1 hour
Title
Pregnancy body mass index
Description
Weight, Height, during
Time Frame
At 8-22 weeks; 35 weeks of gestation
Title
Pregnancy blood glucose level
Description
Blood glucose measured in milligram per decilitre
Time Frame
At 8-22 weeks; 35 weeks of gestation
Title
Pregnancy hemoglobin count
Description
Hemoglobin count in grams per decilitre
Time Frame
At 8-22 weeks; 35 weeks of gestation
Title
Pregnancy skinfold thickness
Description
Skinfold thicknesses (subscapular, biceps, triceps, suprailiac)
Time Frame
At 8-22 weeks; 35 weeks of gestation
Title
Pregnancy food intake
Description
Quantified food intake past 24 hours
Time Frame
At 8-22 weeks; 35 weeks of gestation
Title
Knowledge of healthy foods
Description
Perceptions towards food, eating habits
Time Frame
At 8-22 weeks; 35 weeks of gestation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penjani R Kamudoni, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monkey bay community hospital
City
Mangochi
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35369896
Citation
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.
Results Reference
derived
PubMed Identifier
34551744
Citation
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.
Results Reference
derived
PubMed Identifier
32419688
Citation
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.
Results Reference
derived

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

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