This presentation was made by Dr. Sirazul Ameen Sahariah (Centre for the Study of Social Change) in the session on 'Implementation research on delivery of interventions during pre-pregnancy through lactation' at the POSHAN Conference "Delivering for Nutrition in India Learnings from Implementation Research", November 9–10, 2016, New Delhi. For more information about the conference visit our website: www.poshan.ifpri.info

1. Improving women’s diet quality preconceptionally and
during gestation: effects on birth weight and prevalence of
low birth weight—a randomized controlled efficacy trial in
India (Mumbai Maternal Nutrition Project)
Sirazul A Sahariah1, Ramesh D Potdar,1Meera Gandhi1, Monika Dayama1, Nick Brown2, Harshad
Sane1, Patsy J Coakley3, Ella Marley-Zagar3, Harsha Chopra1, Sarah Kehoe3, Devi Shivshankaran1,
Vanessa A Cox3, Vijaya Taskar4, Barrie M Margetts5, Caroline HD Fall3
1Centre for Study of Social Change, Mumbai, India; 2Salisbury District Hospital, UK; 3MRC
Lifecourse Epidemiology Unit, University of Southampton, UK; 4Streehitkarini, Mumbai, India;
5Public Health Nutrition, University of Southampton, UK
neha
www.controlled-trials.com ISRCTN62811278

2. Background:
• Low birth weight (LBW) is common in undernourished
populations in low- and middle-income countries
• One third of Indian babies are born under weight.
• LBW is associated with increased perinatal mortality and
childhood stunting, poorer childhood cognitive function
predominantly because of intrauterine growth restriction.
• It is also associated high risk of adult diseases. (high BP, Heart
disease, Diabetes and other chronic diseases)
• The Pune Maternal Nutrition Study (PMNS)
– Mothers who had higher intakes of green leafy vegetables,
fruit and milk had babies which were larger in all body
measurements at birth.*
*Rao S et al. (2001) Intake of micronutrient-rich foods in rural Indian mothers is associated with the size of their
babies at birth. Pune Maternal Nutrition Study. J. Nutr. 131: 1217–1224.

3. The intervention
• Objective: To test whether improving women’s dietary
micronutrient quality before conception and throughout pregnancy
increases birth weight in a high-risk Indian population.
• We aimed to improve diet quality rather than specific nutrient
intakes by raising intakes of green leafy vegetables, fruit, and milk.
• The intervention was a daily snack made from green leafy
vegetables, fruit and milk, provided for at least three months prior
to conception and throughout pregnancy.
• We created a snack that, when taken 3 d/wk in addition to the
usual diet, increased women’s average intakes of green leafy
vegetables, fruit, and milk above the highest quartile in the Pune
study
• On average, treatment snacks contained 10–23% of the WHO/FAO
recommended Reference Nutrient Intakes for β-carotene,
riboflavin, folate, vitamin B-12, calcium, and iron.

4. Methods
• Period: Jan 2006 to June 2012
• Study settings: Slum areas of
Mumbai.
• Participants: Married non-pregnant
women aged < 40 years, who had not
completed their family.
• Community consent
• Eligible participant were recruited
following written informed consent
– Basic data and anthropometry
– FFQ including physical activity
– ID photograph
• Participants were randomised (by
age and BMI)

5. Methods
• Freshly prepared supplements were
transported to 61 centres daily
between 3 – 6 PM. (110 recepies
developed)
• Women received supplement under
supervision and recorded.
• Women who became pregnant were
followed three times during
pregnancy.
• Babies were measured within 72
hours of birth in hospital or at home.

6. TOTAL WOMEN RECRUITED
N=6513
RANDOMIZED TO
TREATMENT GROUP
N = 3205
RANDOMIZED TO
CONTROL GROUP
N = 3308
PREGNANCIES
FOLLOWED UP
N = 1106
PREGNANCIES
FOLLOWED UP
N = 1185
STARTED SUPPLEMENT >90
DAYS BEFORE LMP DATE
N=857
STARTED SUPPLEMENT <90
DAYS BEFORE LMP DATE
N=249
STARTED SUPPLEMENT >90
DAYS BEFORE LMP DATE
N=969
STARTED SUPPLEMENT <90
DAYS BEFORE LMP DATE
N=216
SINGLETON LIVE
NEWBORNS WITHOUT MAJOR
CONGENITAL ABNORMALITIES
N=736
SINGLETON LIVE
NEWBORNS WITHOUT MAJOR
CONGENITAL ABNORMALITIES
N=221
SINGLETON LIVE
NEWBORNS WITHOUT MAJOR
CONGENITAL ABNORMALITIES
N=826
SINGLETON LIVE
NEWBORNS WITHOUT MAJOR
CONGENITAL ABNORMALITIES
N=179
Natural abortion 17
Termination 11
Twin pregnancy 2
Single stillbirth/IUD 5
Major abnormality 1
Maternal death 0
Unknown outcome 3
Not measured 75
Measured >10 days 2
NEWBORN
ANTHROPOMETRY
N=518
NEWBORN
ANTHROPOMETRY
N=144
NEWBORN
ANTHROPOMETRY
N=576
NEWBORN
ANTHROPOMETRY
N=122
Natural abortion 60
Termination 47
Twin pregnancy 10
Single stillbirth/IUD 10
Major abnormality 6
Maternal death 3
Unknown outcome 8
Natural abortion 48
Termination 39
Twin pregnancy 13
Single stillbirth/IUD 15
Major abnormality 4
Maternal death 0
Unknown outcome 5
Natural abortion 9
Termination 10
Twin pregnancy 1
Single stillbirth/IUD 1
Major abnormality 1
Maternal death 0
Unknown outcome 6
STAYED IN THE STUDY BUT NEVER
BECAME PREGNANT 755
DROPPED OUT OF THE STUDY BEFORE
BECOMING PREGNANT 1108
BECAME PREGNANT TOO EARLY
EXCLUDED AND NOT FOLLOWED
FURTHER 160
STAYED IN THE STUDY BUT NEVER
BECAME PREGNANT 692
DROPPED OUT OF THE STUDY BEFORE
BECOMING PREGNANT 1135
BECAME PREGNANT TOO EARLY
EXCLUDED AND NOT FOLLOWED
FURTHER 272
Not measured 216
Measured >10 days 2
Not measured 247
Measured >10 days 3
Not measured 57
Measured >10 days 0
2291
1826
1562
1094
CONSORT DIAGRAM

7. Results
• LBW: 34% vs. 41%; OR: 0.76; 95%
CI: 0.59, 0.98 (P = 0.03) : 24%
• Small-for-gestational-age: 66% vs.
71%; OR: 0.80; 95% CI: 0.61, 1.04 (P
=0.09) : 20%
• No change in….
• Large-for-gestational-age
infants (0.6% vs. 0.5%; P = 1.0)
• Preterms (12.7% vs. 12.3%; P
= 0.87)
The prevalence of GDM (WHO 1999
criteria): 9.9%.
• 7.5% vs. 13.1%, P = 0.01; OR:
0.54; 95% CI: 0.33, 0.86)
Birthweight(g)
ALL WOMEN
CONTROL
TREATMENT
Mother’s pre-pregnant BMI
(kg/m2)
<18.6 18.6-21.8 >21.8
+ 48g - 7g + 79g + 113g
Mean and 95% confidence intervals
p=0.05 p=0.84 p=0.07 p=0.008
p for interaction=0.001

8. Scaling-up
• Intervention is scalable
– Ways to make GLV, fruits available (rural Maharashtra)
• Barriers to fruit and vegetable consumption
• Barriers to production and supply of fruit and vegetables
– Teach women to cook (individual or with self help
group)
– Using social enterprise (Integration of maternal health
with non-communicable disease surveillance)
– Commercial food companies

9. Summary
• There was modest increase in birthweight
(48gms)
• Higher effect on women with high BMI (113
gms)
• Reduction of LBW (24%) and SGA (20%)
• Reduction of GDM by 46%
• Possibility of scaling up needs more study.

10. Acknowledgement
• Study participants an their families
• Collaborators:
– SNEHA India.
– JJ and Nair Hospital, Mumbai
– KEM Hospital Pune
– Dr Dharap’s Lab Mumbai
– Dr Joshi’s Imaging Clinic, Mumbai
– Municipal Corporation of Greater Mumbai
• Funders:
– ICCHN and ICICI Foundation
– The Wellcome Trust
– DFID, UK
– Medical Research Council, UK,
– Parthenon Trust, Switzerland.
The study is published and available free on line
Am J Clin Nutr doi: 10.3945/ajcn.114.084921. Thank You !