- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05448287
Suaahara Impact Evaluation: End-line Survey
Study Overview
Status
Conditions
Detailed Description
The Government of Nepal and development partners have prioritized multi-sectoral (integrated) nutrition as a key development agenda. The Suaahara program funded by the United States Agency for International Development is one of the programs that support the Government of Nepal's multi-sectoral nutrition plan. It aims to reduce maternal and child under-nutrition over a period of ten years, spanning two phases: Suaahara I (2011-2016) and Suaahara II (2016-2021). Initially launched in 20 of 75 districts, the program has scaled-up to 42 of 77 districts that span across Nepal's three agroecological zones of mountains, hills, and terai.
Suaahara I was led by Save the Children International in partnership with Helen Keller International, Johns Hopkins University Center for Communications Programs, Jhpiego, Nepal Water for Health (NEWAH), the National Promotion and Consultancy Service, and the Nepali Technical Assistance Group (NTAG). Suaahara II was led by Helen Keller International in partnership with Cooperative for Assistance and Relief Everywhere, Inc., Family Health International 360), he Nepali Technical Assistance Group, Digital Broadcast Initiative Equal Access, Environmental and Public Health Organization, and Vijaya Development Resource Center.
Suaahara's primary aim is to reduce the prevalence of stunting, wasting, and underweight among children under 5 years of age and to reduce the prevalence of anemia among women of reproductive age and children 6-59 months of age. For this, the program uses a multi-sectoral approach to achieve four key intermediate results (IRs): 1) improved household nutrition, sanitation, and health behaviors; 2) increased use of quality nutrition and health services by women and children; 3) improved access to diverse and nutrient-rich foods by women and children; and 4) accelerated roll-out of the MSNP through strengthened local governance. Suaahara interventions span health and family planning (FP), nutrition, agriculture/homestead food production (HFP), and water, sanitation and hygiene (WASH). Diverse social and behavior change communication interventions are used, primarily to generate demand for access to improved services and to motivate households to adopt optimal health, nutrition, and WASH practices. All Suaahara interventions are supported by a crosscutting theme of gender equality and social inclusion (GESI), in part by targeting women and disadvantaged groups and conducting activities that address GESI-related barriers to optimal health, nutrition, and WASH behaviors. Suaahara's conceptual framework illustrates the paths by which the program activities linked to desired outcomes achieve Suaahara II objectives.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Kathmandu, Nepal
- Helen Keller International
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At the household level, the primary respondents are mothers of children under 5 years of age from the selected households.
- Other survey respondents include a primary male (or female, if male unavailable) household decision-maker, and a grandmother of children under 5 years of age residing in the household.
- The Female Community Health Volunteer and health workers are also Suaahara beneficiaries, as the program explicitly aims to improve their knowledge and skills.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Suaahara interventions span health and family planning; nutrition; agriculture/homestead food production; and water, sanitation and hygiene (WASH).
Diverse social and behavior change communication interventions are used, primarily to generate demand for access to improved services and to motivate households to adopt optimal health, nutrition, and WASH practices.
All Suaahara interventions are supported by a crosscutting theme of gender equality and social inclusion (GESI), in part by targeting women and disadvantaged groups and conducting activities that address GESI-related barriers to optimal health, nutrition, and WASH behaviors.
|
Promotion of health and family planning behaviors
Promotion of maternal, infant, and young child feeding behaviors and nutrition
Promotion of knowledge and practices about homestead food production
Promotion of behaviors to improve water, sanitation, and hygiene
|
|
No Intervention: Comparison
Usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices)
Time Frame: Over the 24 hours of the day before data collection
|
Mean score, range 0 to 8, higher is better
|
Over the 24 hours of the day before data collection
|
|
Maternal dietary diversity (Minimum Dietary Diversity for Women)
Time Frame: Over the 24 hours of the day before data collection
|
Mean score, range 0 to 10, higher is better
|
Over the 24 hours of the day before data collection
|
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Stunting
Time Frame: Over the 24 hours of the day of data collection
|
Prevalence of height or length for age zscore < -2
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Over the 24 hours of the day of data collection
|
|
Underweight prevalence
Time Frame: Over the 24 hours of the day of data collection
|
Prevalence of weight for age zscore < -2
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Over the 24 hours of the day of data collection
|
|
Wasting
Time Frame: Over the 24 hours of the day of data collection
|
Prevalence of weight for length for height zscore < -2
|
Over the 24 hours of the day of data collection
|
|
Maternal underweight
Time Frame: Over the 24 hours of the day of data collection
|
Prevalence of body mass index < 18.5
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Over the 24 hours of the day of data collection
|
|
Maternal anemia
Time Frame: Over the 24 hours of the day of data collection
|
Prevalence < 12 g/dl
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Over the 24 hours of the day of data collection
|
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Anemia among children aged 6-59 months
Time Frame: Over the 24 hours of the day of data collection
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Prevalence < 11 g/dl
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Over the 24 hours of the day of data collection
|
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Accurate health, nutrition, and water, sanitation, and hygiene knowledge and skills among Female Community Health Volunteers and health workers from 52 items
Time Frame: Over the 24 hours of the day of data collection
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Prevalence > 80% correct from 52 items
|
Over the 24 hours of the day of data collection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child minimum dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices)
Time Frame: Over the 24 hours of the day before data collection
|
Prevalence > 4 food groups of 8
|
Over the 24 hours of the day before data collection
|
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Maternal minimum dietary diversity (Minimum Dietary Diversity for Women)
Time Frame: Over the 24 hours of the day before data collection
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Prevalence > 4 food groups of 10
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Over the 24 hours of the day before data collection
|
|
Height for age
Time Frame: Over the 24 hours of the day of data collection
|
Mean z-score
|
Over the 24 hours of the day of data collection
|
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Weight for age
Time Frame: Over the 24 hours of the day of data collection
|
Mean z-score
|
Over the 24 hours of the day of data collection
|
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Weight for height
Time Frame: Over the 24 hours of the day of data collection
|
Mean z-score
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Over the 24 hours of the day of data collection
|
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Maternal body mass index
Time Frame: Over the 24 hours of the day of data collection
|
Mean
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Over the 24 hours of the day of data collection
|
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Maternal hemoglobin
Time Frame: Over the 24 hours of the day of data collection
|
Mean in g/dl
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Over the 24 hours of the day of data collection
|
|
Child hemoglobin
Time Frame: Over the 24 hours of the day of data collection
|
Mean in g/dl
|
Over the 24 hours of the day of data collection
|
|
Knowledge score on core infant and young child feeding practices among mothers from 15 items
Time Frame: Over the 24 hours of the day of data collection
|
Mean score, range 0 to 15, higher is better
|
Over the 24 hours of the day of data collection
|
|
Knowledge score on health and water, sanitation, and hygiene practices among mothers from 37 items
Time Frame: Over the 24 hours of the day of data collection
|
Mean score, range 0 to 37, higher is better
|
Over the 24 hours of the day of data collection
|
|
Female Community Health Volunteers and health workers with ideal practices related to health, nutrition, and water, sanitation, and health from 52 items
Time Frame: Over the 24 hours of the day of data collection
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Prevalence > 80% correct from 52 items
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Over the 24 hours of the day of data collection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward A Frongillo, PhD, University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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