Evaluation of the Rapid Results Approach to improve childhood nutrition in Nepal

ISRCTN	ISRCTN75175305
DOI	https://doi.org/10.1186/ISRCTN75175305
Protocol serial number	Nepal01
Sponsor	The World Bank (USA)
Funder	The World Bank (USA)

Submission date: 26/08/2013
Registration date: 10/09/2013
Last edited: 19/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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)

Contact information

Dr Marcos Vera-Hernandez
Scientific

Department of Economics
University College London
Gower Street
London
WC1E 6BT
United Kingdom

Email	m.vera@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomized trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Evaluation of the Rapid Results Approach to improve childhood nutrition in Nepal: a cluster randomized trial
Study acronym	RRAN
Study objectives	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(s)	1. Nepal Health Research Council, reg. 79/2013 2. UCL Research Ethics Committee, protocol ID 1827/005
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2015

Eligibility

Participant type(s)	Other
Age group	Mixed
Sex	All
Target sample size at registration	20586
Key inclusion criteria	1. Children aged 0-24 months 2. Pregnant women 3. Women aged between 15 years and 25 years old
Key exclusion criteria	Children who are unable to be measured
Date of first enrolment	30/08/2013
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England
Nepal

Study participating centre

University College London

London
WC1E 6BT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			19/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN75175305_BasicResults.pdf: Basic results

Editorial Notes

19/06/2023: The basic results have been uploaded as an additional file.