Plain English Summary

Background and study aims
Low birth weight is a major contributor to mortality during infancy. This study was designed to see if supplementing rural African women with a high energy and protein dietary supplement from mid-pregnancy to delivery would improve both low birth weight and infant survival.

Who can participate?
The study enrolled consenting pregnant women living in the West Kiang region of The Gambia.

What does the study involve?
This study is completed, having run between January 1989 and October 1994. Women in 28 villages in rural Gambia were randomly allocated to one of two groups: to receive a biscuit supplement from either mid-pregnancy to delivery (intervention group) or from delivery for 20 weeks (control group). Birth weight, length and head circumference and survival of the infants up to 12 months of age was assessed.

What are the possible benefits and risks of participating?
These are the findings of the study: Supplementation during pregnancy increased birth weight by 136g. The supplement had greatest impact when given during the nutritionally poor 'hungry season (+201g). In addition, the supplement reduced the prevalence of babies born with a low birth weight (<2500g). Supplementation also reduced the risk of stillbirths and deaths during the first week of life. This study showed that giving a high energy and protein supplement to women during pregnancy in rural Gambia can improve birth weight and early neonatal survival.

Where is the study run from?
The study was run from the Medical Research Council (UK) Keneba field station, in Keneba, The Gambia.

When is the study starting and how long is it expected to run for?
The study started in 1989 and field work was completed in 1994. It was published in 1997.

Who is funding the study?
The study was funded by the Medical Research Council (UK), the Overseas Development Administration (UK) and the Nestle Foundation (Switzerland).

Who is the main contact?
Professor Andrew Prentice
Andrew.Prentice@lshtm.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Prentice

ORCID ID

Contact details

MRC International Nutrition Group
Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
andrew.prentice@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial

Acronym

Study hypothesis

Antenatal high-energy supplementation improves birth weight and infant survival in rural Gambia

Ethics approval

Ethical approval given by the joint Gambia Government / MRC Unit The Gambia Ethics Committee.

Study design

5 year cluster randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not provided at time of registration - N/A as study ended in 1994.

Condition

Pregnancy and lactation

Intervention

5 year cluster randomized trial of pregnant women in 28 villages in rural Gambia to daily supplementation with high energy biscuits for 20 weeks pre-delivery (intervention) or post-delivery (control).

Two biscuits daily, made locally from roasted groundnuts, rice flour, sugar and groundnut oil and providing a maximum daily intake of 4250 kJ energy, 22 g protein, 56 g fat, 47 mg calcium and 1.8mg iron. Biscuits were distributed to birth attendants in each village, who issued them to participating women and observed consumption.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Birth weight
2. Neonatal and postneonatal mortality

Secondary outcome measures

1. Prevalence of low birth weight (< 2500g)
2. Head circumference
3. Birth length
4. Gestational age
5. Prevalence of stillbirths

Overall trial start date

01/01/1989

Overall trial end date

31/10/1994

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant, with < 20 weeks gestation
2. Resident in West Kiang region of The Gambia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2047

Participant exclusion criteria

Twin pregnancies

Recruitment start date

01/01/1989

Recruitment end date

31/10/1994

Locations

Countries of recruitment

Gambia

Trial participating centre

MRC International Nutrition Group
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK) - International Nutrition Group (UK)

Sponsor details

Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
andrew.prentice@lshtm.ac.uk

Sponsor type

Research council

Website

http://www.ing.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council, Overseas Development Administration and Nestle Foundation.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1997 results in: http://www.ncbi.nlm.nih.gov/pubmed/9345173
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24132979

Publication citations

  1. Results

    Ceesay SM, Prentice AM, Cole TJ, Foord F, Weaver LT, Poskitt EM, Whitehead RG, Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial ., BMJ, 1997, 315, 7111, 786-790.

  2. Results

    Alderman H, Hawkesworth S, Lundberg M, Tasneem A, Mark H, Moore SE, Supplemental feeding during pregnancy compared with maternal supplementation during lactation does not affect schooling and cognitive development through late adolescence., Am. J. Clin. Nutr., 2014, 99, 1, 122-129, doi: 10.3945/ajcn.113.063404.

Editorial Notes