Nutritional StuntingPhase 3NCT05448287
Suaahara Impact Evaluation: End-line Survey
A Phase 3 study testing Health and family planning, Nutrition and Agriculture and homestead food production in people with Nutritional Stunting and Feeding Behavior, run by University of South Carolina at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 0 to 60 months
- Conditions the study is for
- Nutritional Stunting, Feeding Behavior
- What is being tested?
- Health and family planning, Nutrition and Agriculture and homestead food production
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteNepal
- Study dates
- 17 Jun 2022to 30 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Nutritional Stunting, Feeding Behavior
- Being tested
- Health and family planning, Nutrition, Agriculture and homestead food production, Water, sanitation, and hygiene
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and family planningBehavioural
Promotion of health and family planning behaviors
NutritionBehavioural
Promotion of maternal, infant, and young child feeding behaviors and nutrition
Agriculture and homestead food productionBehavioural
Promotion of knowledge and practices about homestead food production
Water, sanitation, and hygieneBehavioural
Promotion of behaviors to improve water, sanitation, and hygiene
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Health and family planning; Behavioral: Nutrition; Behavioral: Agriculture and homestead food production; Behavioral: Water, sanitation, and hygiene |
| Comparison | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices)
Mean score, range 0 to 8, higher is better
Measured: Over the 24 hours of the day before data collection
Maternal dietary diversity (Minimum Dietary Diversity for Women)
Mean score, range 0 to 10, higher is better
Measured: Over the 24 hours of the day before data collection
Stunting
Prevalence of height or length for age zscore < -2
Measured: Over the 24 hours of the day of data collection
Underweight prevalence
Prevalence of weight for age zscore < -2
Measured: Over the 24 hours of the day of data collection
Wasting
Prevalence of weight for length for height zscore < -2
Measured: Over the 24 hours of the day of data collection
Maternal underweight
Prevalence of body mass index < 18.5
Measured: Over the 24 hours of the day of data collection
Maternal anemia
Prevalence < 12 g/dl
Measured: Over the 24 hours of the day of data collection
Anemia among children aged 6-59 months
Prevalence < 11 g/dl
Measured: Over the 24 hours of the day of data collection
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
Measured: Over the 24 hours of the day of data collection
Secondary outcomes (11)
Child minimum dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices)
Prevalence > 4 food groups of 8
Measured: Over the 24 hours of the day before data collection
Maternal minimum dietary diversity (Minimum Dietary Diversity for Women)
Prevalence > 4 food groups of 10
Measured: Over the 24 hours of the day before data collection
Height for age
Mean z-score
Measured: Over the 24 hours of the day of data collection
Weight for age
Mean z-score
Measured: Over the 24 hours of the day of data collection
Weight for height
Mean z-score
Measured: Over the 24 hours of the day of data collection
Maternal body mass index
Mean
Measured: Over the 24 hours of the day of data collection
Maternal hemoglobin
Mean in g/dl
Measured: Over the 24 hours of the day of data collection
Child hemoglobin
Mean in g/dl
Measured: 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
Mean score, range 0 to 15, higher is better
Measured: 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
Mean score, range 0 to 37, higher is better
Measured: 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
Prevalence > 80% correct from 52 items
Measured: Over the 24 hours of the day of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start17 Jun 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm quasi-experimental design with baseline and end-line. The baseline and end-line were collected on different households but in the same clusters.
- Masking
- None (open label)
- Enrolment
- 2,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International
- Responsible party
- Principal investigator, Edward Frongillo, Jr., University of South Carolina
- Investigators
- Edward A Frongillo, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448287
- Sponsor's protocol ID
- 103
- Status last verified
- Jan 2023
- First submitted
- 16 Jun 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frongillo EA, Suresh S, Thapa DK, Cunningham K, Pandey Rana P, Adhikari RP, Kole S, Pun B, Kshetri I, Adhikari DP, Klemm R. Impact of Suaahara, an integrated nutrition programme, on maternal and child nutrition at scale in Nepal. Matern Child Nutr. 2026 Mar;22(1):e13630. doi: 10.1111/mcn.13630. Epub 2024 Feb 11.
PubMed 38342986
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suaahara Impact Evaluation: End-line Survey
- ClinicalTrials.gov ID
- NCT05448287
- Acronym / sponsor ID
- 103
- Conditions
- Nutritional Stunting, Feeding Behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,480 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Helen Keller International
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm quasi-experimental design with baseline and end-line. The baseline and end-line were collected on different households but in the same clusters.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health and family planning, Behavioral: Nutrition, Behavioral: Agriculture and homestead food production, Behavioral: Water, sanitation, and hygieneSuaahara 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. |
| Comparison | No intervention | –Usual care. |
Who may qualify
- Ages
- 0 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health and family planningPromotion of health and family planning behaviors | Behavioural | Intervention |
| NutritionPromotion of maternal, infant, and young child feeding behaviors and nutrition | Behavioural | Intervention |
| Agriculture and homestead food productionPromotion of knowledge and practices about homestead food production | Behavioural | Intervention |
| Water, sanitation, and hygienePromotion of behaviors to improve water, sanitation, and hygiene | Behavioural | Intervention |
Primary outcome
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
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
Stunting
Time frame: Over the 24 hours of the day of data collection
Prevalence of height or length for age zscore < -2
Underweight prevalence
Time frame: Over the 24 hours of the day of data collection
Prevalence of weight for age zscore < -2
Wasting
Time frame: Over the 24 hours of the day of data collection
Prevalence of weight for length for height zscore < -2
Maternal underweight
Time frame: Over the 24 hours of the day of data collection
Prevalence of body mass index < 18.5
Maternal anemia
Time frame: Over the 24 hours of the day of data collection
Prevalence < 12 g/dl
Anemia among children aged 6-59 months
Time frame: Over the 24 hours of the day of data collection
Prevalence < 11 g/dl
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
Prevalence > 80% correct from 52 items
11 secondary outcomes
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
Maternal minimum dietary diversity (Minimum Dietary Diversity for Women)
Time frame: 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
Weight for age
Time frame: Over the 24 hours of the day of data collection
Weight for height
Time frame: Over the 24 hours of the day of data collection
Maternal body mass index
Time frame: Over the 24 hours of the day of data collection
Maternal hemoglobin
Time frame: Over the 24 hours of the day of data collection
Child hemoglobin
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 38342986Frongillo EA, Suresh S, Thapa DK, Cunningham K, Pandey Rana P, Adhikari RP, Kole S, Pun B, Kshetri I, Adhikari DP, Klemm R. Impact of Suaahara, an integrated nutrition programme, on maternal and child nutrition at scale in Nepal. Matern Child Nutr. 2026 Mar;22(1):e13630. doi: 10.1111/mcn.13630. Epub 2024 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward A Frongillo, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Health and family planning, Nutrition and Agriculture and homestead food production in people with Nutritional Stunting and Feeding Behavior, run by University of South Carolina at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child dietary diversity (Indicators for Assessing Infant and Young Child Feeding Practices) (time frame: Over the 24 hours of the day before data collection). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.