Plain English Summary
Background and study aims
This study will assess the impact of Sunaula Hazar Din (SHD), a program implemented by the Government of Nepal. SHD uses the Rapid Results Approach (RRA) to improve nutritional indicators of pregnant women and children 0 to 24 months old, as well as family planning of women aged 15-25 years old. The evaluation will measure its effect on nutritional attitudes and outcomes. RRA is a results-focused learning process aimed at jump-starting major change efforts and enhancing implementation capacity. The approach creates motivation and confidence by defining goals and monitoring results in short periods (usually 100 days) and mobilizing communities to act and coordinate.
Who can participate?
Children 0-24 months and their mothers, pregnant women, and women aged 15-25 years old who live in selected Village Development Committees across 15 districts of Nepal.
What does the study involve?
Over a period of 18 months, SHD will be implemented in randomly selected Village Development Committees. Community members can voluntarily participate in the activities organized by SHD in their Village Development Committee. Interviews and anthropometric measurements (such as height and weight) of children will be carried out at the start of the study and 24 months later to find out the impact of SHD on family planning and nutritional indicators.
What are the possible benefits and risks of participating?
Participants who live in a Village Development Committee which has been randomly chosen to receive the programme will benefit from the activities of SHD in their community. We do not anticipate risks related to participation in the study.
Where is the study run from?
The study is run from Village Development Committees across 15 districts of Nepal.
When is the study starting and how long is it expected to run for?
Initial information will be collected in August 2013 and program implementation is expected to start in December 2013. Final data collection is expected to start in August 2015.
Who is funding the study?
The World Bank, USA.
Who is the main contact?
1. Dr Emla Fitzsimons (emla_f@ifs.org.uk)
2. Dr Marcos Vera-Hernandez (m.vera@ucl.ac.uk)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marcos Vera-Hernandez
ORCID ID
Contact details
Department of Economics
University College London
Gower Street
London
WC1E 6BT
United Kingdom
-
m.vera@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Nepal01
Study information
Scientific title
Evaluation of the Rapid Results Approach to improve childhood nutrition in Nepal: a cluster randomized trial
Acronym
RRAN
Study hypothesis
It is hypothesized that the Rapid Results Approach will improve family planning and nutritional indicators of children and pregnant women in selected districts of Nepal. The null hypothesis is that there will be no difference in donations between treatment groups;
Ethics approval
1. Nepal Health Research Council, reg. 79/2013
2. UCL Research Ethics Committee, protocol ID 1827/005
Study design
Cluster randomized trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Community interventions to improve nutritional and family planning outcomes
Intervention
The Rapid Results Approach (RRA) will be implemented in randomly selected Village Development Committees. The RRA is a results-focused learning process aimed at jump-starting major change efforts and enhancing implementation capacity. It tackles large-scale medium and long term change efforts through a series of small-scale, results-producing and momentum-building initiatives. The approach creates motivation and confidence by defining goals and monitoring results in short periods (usually 100 days) and mobilizing communities to act and coordinate.
The control group are individuals living in randomly selected Village Development Committees which will not benefit from SHD for a two year period
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measures as of 15/12/2015:
1.Height for age z-score for children 0-24 months
2. Percentage of children between 0-24 months that suffered from diarrhoea in the 15 days prior to the interview.
Previous primary outcome measures:
1. Percentage of unmet family planning needs among women 15-25 years of age
2. Percentage of pregnant women taking iron and folic acid supplements for 180 days
3. Percentage of children 0-6 months age who are exclusively breastfed
4. Percentage of children 6-24 months age who consume a minimum acceptable diet
The primary outcomes will be measured using structured questionnaires. They will be measured at baseline to assess the comparability of treatment and control Village Development Committees. They will also be measured 24 months after baseline to assess the impact of the intervention.
Secondary outcome measures
Current secondary outcome measures as of 15/12/2015:
1. Number of instances in which a mother (of children 0-24 months) reports to clean her hands with soap at critical times
2. Percentage of households that report to have human feces in the house, compound, or right outside the compound
3. Percentage of households that report to have animal feces in the house, compound, or right outside the compound
4. Percentage of households using safe sources of water
5. Percentage of children 6-24 months whose mother reported to consume a minimum acceptable diet on the day prior to the interview
6. Percentage of children 6-24 months whose mother reported to consume an animal sourced protein on the day prior to the interview
7. Percentage of pregnant women who report consuming an animal sourced protein on the day prior to the interview
8. Social capital
9. A composite index comprising outcomes related to the goals of SHD
Previous secondary outcome measures:
1. Percentage of children 0-24 months who are stunted (height for age z-score less than -2)
2. Percentage of children 0-24 months who suffer from underweight (weight for age z-score less than -2)
3. Social capital
4. A composite index comprising outcomes related to the 30 goals of SHD
Overall trial start date
30/08/2013
Overall trial end date
31/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 0-24 months
2. Pregnant women
3. Women aged between 15 years and 25 years old
Participant type
Other
Age group
Mixed
Gender
Both
Target number of participants
20586
Participant exclusion criteria
Children who are unable to be measured
Recruitment start date
30/08/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Nepal
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
The World Bank (USA)
Sponsor details
c/o Dan Stein
Development Impact Evaluation Initiative
1818 H Street
NW
Washington
DC
20433
United States of America
-
dstein@worldbank.org
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
The World Bank (USA)
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