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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05448287
Other study ID # 103
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 17, 2022
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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: 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 Multi-Sectoral Nutrition Plan (MSNP) through strengthened local governance


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.


Recruitment information / eligibility

Status Completed
Enrollment 2480
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Months to 60 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health and family planning
Promotion of health and family planning behaviors
Nutrition
Promotion of maternal, infant, and young child feeding behaviors and nutrition
Agriculture and homestead food production
Promotion of knowledge and practices about homestead food production
Water, sanitation, and hygiene
Promotion of behaviors to improve water, sanitation, and hygiene

Locations

Country Name City State
Nepal Helen Keller International Kathmandu

Sponsors (2)

Lead Sponsor Collaborator
University of South Carolina Helen Keller International

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices) Mean score, range 0 to 8, higher is better Over the 24 hours of the day before data collection
Primary Maternal dietary diversity (Minimum Dietary Diversity for Women) Mean score, range 0 to 10, higher is better Over the 24 hours of the day before data collection
Primary Stunting Prevalence of height or length for age zscore < -2 Over the 24 hours of the day of data collection
Primary Underweight prevalence Prevalence of weight for age zscore < -2 Over the 24 hours of the day of data collection
Primary Wasting Prevalence of weight for length for height zscore < -2 Over the 24 hours of the day of data collection
Primary Maternal underweight Prevalence of body mass index < 18.5 Over the 24 hours of the day of data collection
Primary Maternal anemia Prevalence < 12 g/dl Over the 24 hours of the day of data collection
Primary Anemia among children aged 6-59 months Prevalence < 11 g/dl Over the 24 hours of the day of data collection
Primary Accurate health, nutrition, and water, sanitation, and hygiene knowledge and skills among Female Community Health Volunteers and health workers from 52 items Prevalence > 80% correct from 52 items Over the 24 hours of the day of data collection
Secondary Child minimum dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices) Prevalence > 4 food groups of 8 Over the 24 hours of the day before data collection
Secondary Maternal minimum dietary diversity (Minimum Dietary Diversity for Women) Prevalence > 4 food groups of 10 Over the 24 hours of the day before data collection
Secondary Height for age Mean z-score Over the 24 hours of the day of data collection
Secondary Weight for age Mean z-score Over the 24 hours of the day of data collection
Secondary Weight for height Mean z-score Over the 24 hours of the day of data collection
Secondary Maternal body mass index Mean Over the 24 hours of the day of data collection
Secondary Maternal hemoglobin Mean in g/dl Over the 24 hours of the day of data collection
Secondary Child hemoglobin Mean in g/dl Over the 24 hours of the day of data collection
Secondary Knowledge score on core infant and young child feeding practices among mothers from 15 items Mean score, range 0 to 15, higher is better Over the 24 hours of the day of data collection
Secondary Knowledge score on health and water, sanitation, and hygiene practices among mothers from 37 items Mean score, range 0 to 37, higher is better Over the 24 hours of the day of data collection
Secondary Female Community Health Volunteers and health workers with ideal practices related to health, nutrition, and water, sanitation, and health from 52 items Prevalence > 80% correct from 52 items Over the 24 hours of the day of data collection
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