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The Low Birth Weight in South Asia Trial (LBWSAT): can birth weight in the plains of Nepal be cost-effectively increased using a behaviour change strategy (BSC) involving women?s groups alone or by BCS with either a food or cash transfer?

The Low Birth Weight in South Asia Trial (LBWSAT): a cluster randomised controlled trial to determine the relative cost effectiveness of a participatory behaviour change strategy (BCS) alone, or BCS plus a food or cash transfer for increasing birth weight in plains Nepal compared with current programmes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75964374
Enrollment
17000
Registered
2013-07-12
Start date
2013-12-29
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low birth weight Pregnancy and Childbirth Other low birth weight

Interventions

Behaviour change strategy We will work with women?s groups already organised by the government-supported Female Community Health Volunteers (FCHVs) in each ward of 60 Village Development Committees (V

Sponsors

Department for International Development (DFID) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Individual participant inclusion criteria: 1. All women of reproductive age who are permanent residents of the study areas are eligible for inclusion in menstrual monitoring. 2. All pregnant women identified within the surveillance system before 20 weeks gestation are eligible for inclusion in monitoring of pregnancy weight gain and diet and for receipt of transfers (in transfer areas). 3. All babies born to women permanently resident in the study clusters are eligible for inclusion in birth weight outcomes and 4-6 week interviews, so long as they can be weighed within 72 hours. 4. Any woman residing in behaviour change strategy areas may participate in women?s groups and any family members of pregnant women may participate in groups for men or mother-in-laws. Cluster (or study area) inclusion criteria: 1. Village Development Committee (VDC) in Dhanusha or Mahottari districts of Nepal with 4000 to 9000 estimated population 2. Received not previous women?s group intervention using participatory learning and action approach 3. Does not contain a large town or municipality

Exclusion criteria

Exclusion criteria: Individual participant exclusion criteria: 1. Birth weight obtained more than 72 hours after birth 2. Woman temporarily resident in the study clusters (i.e. not spending most of her pregnancy in the area and/or not planning to be in the area when the baby is born) Cluster (or study area) exclusion criteria: 1. Smaller than 4000, or larger than 9200 population 2. VDC contains a large town or municipality 3. VDC had a previous women?s group implemented by MIRA between 2007 and 2011 4. Cluster has hills, borders the E-W highway in the north of the districts, or has large hills ethnicity population

Design outcomes

Primary

MeasureTime frame
Birth weight accurate to 10g measured within 72 hours

Secondary

MeasureTime frame
1. Prevalence of low birth weight (% < 2500g) 2. Maternal weight gain during pregnancy (difference between first and third trimester weight, adjusted for gestation) 3. Preterm delivery (based on LMP)/gestational age at delivery 4. Miscarriages 5. Stillbirths 6. Neonatal mortality 7. Maternal morbidity during pregnancy 8. Neonatal morbidity 9. Maternal eating behaviour in pregnancy (eating down/less, maternal 24-hour dietary diversity score in early and late pregnancy, consumption of key micronutrient-rich foods, number of eating occasions per day, observance of food taboos and fasting) 10. Exposure to women?s groups by pregnant women and family members (attendance, home visits and awareness-raising activities in the community) 11. Access to food transfer and recall of its use in the household 12. Access to cash transfers and how it was spent 13. Intra-household food allocation

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026