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Trial record 55 of 110 for:    test | ( Map: Malawi )

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

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ClinicalTrials.gov Identifier: NCT03136393
Recruitment Status : Unknown
Verified April 2017 by Penjani Rhoda Kamudoni, University of Oslo.
Recruitment status was:  Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Collaborators:
University of Malawi
University of Adelaide
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Penjani Rhoda Kamudoni, University of Oslo

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.


Condition or disease Intervention/treatment Phase
Maternal Exposure During Pregnancy Behavioral: Community based dietary counselling Behavioral: Community based antenatal counselling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : April 12, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

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 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.

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




Primary Outcome Measures :
  1. Infant birthweight [ Time Frame: 1 hour ]
    Infant birthweight measured within an hour after birth


Secondary Outcome Measures :
  1. Infant birth length [ Time Frame: 1 hour ]
    Infant birth length measured within an hour after birth

  2. Infant birth head circumference [ Time Frame: 1 hour ]
    Infant head circumference measured within an hour after birth

  3. Infant birth abdomen circumference [ Time Frame: 1 hour ]
    Infant birth abdomen circumference measured within an hour after birth

  4. Pregnancy body mass index [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Weight, Height, during

  5. Pregnancy blood glucose level [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Blood glucose measured in milligram per decilitre

  6. Pregnancy hemoglobin count [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Hemoglobin count in grams per decilitre

  7. Pregnancy skinfold thickness [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Skinfold thicknesses (subscapular, biceps, triceps, suprailiac)

  8. Pregnancy food intake [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Quantified food intake past 24 hours

  9. Knowledge of healthy foods [ Time Frame: At 8-22 weeks; 35 weeks of gestation ]
    Perceptions towards food, eating habits



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136393


Locations
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Malawi
Monkey bay community hospital
Mangochi, Malawi
Sponsors and Collaborators
University of Oslo
University of Malawi
University of Adelaide
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Penjani R Kamudoni, PhD University of Oslo

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Responsible Party: Penjani Rhoda Kamudoni, Dr, University of Oslo
ClinicalTrials.gov Identifier: NCT03136393     History of Changes
Other Study ID Numbers: NFR-220895
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Penjani Rhoda Kamudoni, University of Oslo:
nutrition
pregnancy
birth weight

Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms