Maternal NutritionNCT05443997
Systems Strengthening Interventions to Improve Quality and Co-coverage of Nutrition Services in Gujarat, India
A study testing MIYCN capacity building in people with Maternal Nutrition, run by International Food Policy Research Institute at 1 site in United States.
Trial summary
Progress on child growth outcomes such as stunting requires both direct and indirect actions across multiple sectors. Recognizing the importance of multisector approaches in reducing child undernutrition, Alive \& Thrive (A\&T) India aims to improve the quality of health and nutrition services, as well as their… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Nutrition
- What is being tested?
- MIYCN capacity building
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 30 Jul 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers with children <2 years of age who are registered with the Anganwadi Center to receive services under the ICDS
- Pregnant women in first, second and third trimester who are registered with the Anganwadi Center to receive services under the ICDS
- Frontline health workers in the areas
- Supervisors/managers in the areas
- Key informants from the Panchayati Raj Institutions (PRI)
Who cannot join
- Women who are not currently registered with the local Anganwadi center to receive ICDS services
- Age <18
- Pregnant women with severe illness or complications
- Mothers with severely ill children
- Mental health problems that make it difficult for the respondent to answer the questions
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20006
About this study
Official title: To What Extent do Systems Strengthening Interventions and Engagement With Local Governance Improve the Quality and Co-coverage of Nutrition Services in Gujarat, India? A Cluster-randomized Evaluation
Progress on child growth outcomes such as stunting requires both direct and indirect actions across multiple sectors. Recognizing the importance of multisector approaches in reducing child undernutrition, Alive \& Thrive (A\&T) India aims to improve the quality of health and nutrition services, as well as their convergence at the household level with other available nutrition-sensitive services, in order to improve MIYCN behaviors, and ultimately decrease malnutrition in Gujarat. In line with government priorities, A\&T designed a suite of system strengthening interventions including capacity building, supportive supervision, strategic use of data, improved food supplementation and engagement with local governance to improve the quality and co-coverage of nutrition-relevant services in three districts in Gujarat. This proposed evaluation aims to assess the feasibility of integrating multi-sectoral interventions using a cluster-randomized design with cross-sectional baseline and endline surveys.
Read the detailed description
This study uses a cluster-randomized design with cross-sectional baseline and endline surveys to generate a proof-of-concept around an implementation model that aims to strengthen systems for delivery of individual interventions and to strengthen convergence of multiple interventions on the same households/families. The primary objectives of the study are to answer the following questions:
- To what extent and through which pathways can overall system strengthening approaches improve quality of delivery of health and ICDS services?
- To what extent and through which pathways do system strengthening approaches and focused local efforts to engage multiple sectors improve coverage of individual interventions and co-coverage of multiple interventions in the first 1,000-days?
- Can efforts to improve the nutritional value and palatability of take-home rations within the ICDS increase acceptability and use?
This study will also measure a range of secondary outcomes, for each research question as well as outcomes that pertain to the pathways of impact of the five intervention components. These include
- MIYCN capacity building
- Strengthening Supportive Supervision (SS) of the ICDS \& Health Supervisory Cadre
- Strategic Use of Data (SUD) \& Convergent Action Plan
- Involving Panchayati Raj Members (PRIs) for improved Co-Coverage of nutrition services
- THR offering refinement
Prior to the baseline survey, 13 out of 26 blocks from three districts randomly allocated to receive interventions. Another 13 blocks from the same three districts were randomly allocated to the comparison groups which received standard government services. The selection of three districts was based on the discussion between A\&T team and the Government of Gujarat. A team comprising of representatives from A\&T, IFPRI and local government worked closely to ensure matching and comparability between the intervention and comparison blocks using a propensity score matching method prior to randomization to intervention or comparison groups.
At baseline, information related to primary and secondary outcomes will be collected, along with indicators along the pathway from program inputs to outcomes. Insights on implementation will be documented throughout the evaluation period through routine meetings with the implementation teams, field visits by the research team, review of monitoring data collected by the implementation team, and backend data from the supervisory and PRI apps. Endline will be collected after approximately one year from baseline and will use mixed methods approach wherein surveys will be conducted at the sector, village, and household levels and semi-structured interviews will be conducted with the block and district staff. In addition, observations will be conducted of interactions between supervisors and FLWs at the village level. Finally, an assessment of child growth outcomes will be conducted after exploring the availability and data quality of longitudinal data being gathered at AWCs by IIPH-G, contingent on data access and approval from the state government.
- Conditions
- Maternal Nutrition
- Being tested
- MIYCN capacity building
- Keywords
- Maternal Nutrition, Supportive supervision, MIYCN behaviors, System strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIYCN capacity buildingBehavioural
Also called Strengthening Supportive Supervision (SS) of the ICDS & Health Supervisory Cadre, Strategic Use of Data (SUD) & Convergent Action Plan, Involving Panchayati Raj Members (PRIs) for improved Co-Coverage of nutrition services, THR offering refinement
- MIYCN knowledge, skills, and motivation of FLWs
- Supportive supervision
- Decentralized programmatic decision-making using data
- PRI member involvement
- Availability of THR
- IYCF knowledge and practices
| Study group | Role | What they receive |
|---|---|---|
| A&T- intensive | Experimental | 1. Capacity building will involve offsite training conducted by Vitamin Angels and short capsule trainings delivered by government staff
2. Supportive supervision will involve training and handholding of supervisors on use of job aids and mobile application
3. Strategic use of data will involve setting up processes to review key data, review meetings and short trainings on gap areas.
4. Engagement of Panchayati Raj Institutions (PRI) around convergence where PRI members will be equipped with job aids, including an App
5. Improved food supplements where THR offering for pregnant and lactating women and children 6 months and older will be revisited and improved solutions will be explored. Receives: Behavioral: MIYCN capacity building |
| A&T-non intensive | No intervention | Only receives standard government services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of delivery of health and nutrition interventions
Proportion of beneficiaries receiving all ANC care items (weigh, blood sample taken, blood pressure measured, urine sample taken, abdomen checked),THR supplements and counseling.
Measured: During pregnancy (about 9 months)
Acceptability of reformulated take home ration by pregnant, lactating women and children
Total standardized scores of acceptability to five THR organoleptic properties (taste, smell, texture, color, difficulty of eating), with higher scores representing higher acceptability.
Measured: During pregnancy (about 9 months) and up to 24 months postpartum
Use of reformulated take home ration by pregnant, lactating women and children
Proportion of beneficiaries who consumed THR during pregnancy, lactation or early childhood
Measured: During pregnancy (about 9 months) and up to 24 months postpartum
Co-coverage of multiple interventions from across sectors
- For pregnant women: Proportion of pregnant women receiving at least 7 out of 14 interventions (>=4 ANC, received IFA, tetanus, weighed during ANC, breast feeding and cord counselling, received THR, health \& nutrition education, mosquito net, improved sanitation, clean cooking fuel, met ASHA worker at home, met AWW at home)
- For mothers with children <2y: Proportion of mother-child pairs receiving at least 12 out of 24 interventions (≥ 4 ANC visits, received IFA, tetanus, deworming, weighed during ANC, breastfeeding and cord-care counselling, food supplementation, health and nutrition education, mosquito net, institutional birth, postnatal care for mothers and babies, postnatal food supplementation, postnatal health and nutrition education, counselling on child growth, deworming, pediatric IFA, Vitamin A supplementation, child weighing, home visits by AWW or ASHW, HHs with improved sanitation facility and cooking fuel)
Measured: During pregnancy (about 9 months) and up to 24 months postpartum
Secondary outcomes (5)
MIYCN knowledge of FLWs
Total standardized scores of correct answers to questions related to dietary diversity, micronutrients, and child feeding, with higher scores represent higher knowledge.
Measured: In the 6 months prior to interview date
Supportive supervision
Total standardized scores of frequency and contents discussed during supervisory visits, with higher scores representing higher supervision.
Measured: In the 6 months prior to interview date
Decentralized programmatic decision-making using data
Proportion of supervisors and frontline workers reporting use of any data (on THR distribution, growth monitoring, home visit, IFA/Ca/vaccine stocks etc) in the last 3 months.
Measured: In the 6 months prior to interview date
Panchayati Raj Members (PRI) member involvement
Proportion of PRI members aware of all social safety net programs, ICDS and health services
Measured: In the 6 months prior to interview date
Mother IYCF knowledge and practices
Total standardized scores of correct answers to questions related child feeding based on 2021 WHO recommendation, with higher scores representing higher knowledge.
Measured: During pregnancy (about 9 months) and up to 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start22 Mar 2022
- Primary completion30 May 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal NutritionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The implementation research study uses a cluster-randomized design with cross-sectional baseline and endline surveys
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuong H Nguyen, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443997
- Sponsor's protocol ID
- 00007490
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To What Extent do Systems Strengthening Interventions and Engagement With Local Governance Improve the Quality and Co-coverage of Nutrition Services in Gujarat, India? A Cluster-randomized Evaluation
- ClinicalTrials.gov ID
- NCT05443997
- Acronym / sponsor ID
- 00007490
- Conditions
- Maternal Nutrition
- Keywords
- Maternal Nutrition, Supportive supervision, MIYCN behaviors, System strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 5 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.
Progress on child growth outcomes such as stunting requires both direct and indirect actions across multiple sectors. Recognizing the importance of multisector approaches in reducing child undernutrition, Alive \& Thrive (A\&T) India aims to improve the quality of health and nutrition services, as well as their convergence at the household level with other available nutrition-sensitive services, in order to improve MIYCN behaviors, and ultimately decrease malnutrition in Gujarat. In line with government priorities, A\&T designed a suite of system strengthening interventions including capacity building, supportive supervision, strategic use of data, improved food supplementation and engagement with local governance to improve the quality and co-coverage of nutrition-relevant services in three districts in Gujarat. This proposed evaluation aims to assess the feasibility of integrating multi-sectoral interventions using a cluster-randomized design with cross-sectional baseline and endline surveys.
Detailed description
This study uses a cluster-randomized design with cross-sectional baseline and endline surveys to generate a proof-of-concept around an implementation model that aims to strengthen systems for delivery of individual interventions and to strengthen convergence of multiple interventions on the same households/families. The primary objectives of the study are to answer the following questions:
- To what extent and through which pathways can overall system strengthening approaches improve quality of delivery of health and ICDS services?
- To what extent and through which pathways do system strengthening approaches and focused local efforts to engage multiple sectors improve coverage of individual interventions and co-coverage of multiple interventions in the first 1,000-days?
- Can efforts to improve the nutritional value and palatability of take-home rations within the ICDS increase acceptability and use?
This study will also measure a range of secondary outcomes, for each research question as well as outcomes that pertain to the pathways of impact of the five intervention components. These include
- MIYCN capacity building
- Strengthening Supportive Supervision (SS) of the ICDS \& Health Supervisory Cadre
- Strategic Use of Data (SUD) \& Convergent Action Plan
- Involving Panchayati Raj Members (PRIs) for improved Co-Coverage of nutrition services
- THR offering refinement
Prior to the baseline survey, 13 out of 26 blocks from three districts randomly allocated to receive interventions. Another 13 blocks from the same three districts were randomly allocated to the comparison groups which received standard government services. The selection of three districts was based on the discussion between A\&T team and the Government of Gujarat. A team comprising of representatives from A\&T, IFPRI and local government worked closely to ensure matching and comparability between the intervention and comparison blocks using a propensity score matching method prior to randomization to intervention or comparison groups.
At baseline, information related to primary and secondary outcomes will be collected, along with indicators along the pathway from program inputs to outcomes. Insights on implementation will be documented throughout the evaluation period through routine meetings with the implementation teams, field visits by the research team, review of monitoring data collected by the implementation team, and backend data from the supervisory and PRI apps. Endline will be collected after approximately one year from baseline and will use mixed methods approach wherein surveys will be conducted at the sector, village, and household levels and semi-structured interviews will be conducted with the block and district staff. In addition, observations will be conducted of interactions between supervisors and FLWs at the village level. Finally, an assessment of child growth outcomes will be conducted after exploring the availability and data quality of longitudinal data being gathered at AWCs by IIPH-G, contingent on data access and approval from the state government.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The implementation research study uses a cluster-randomized design with cross-sectional baseline and endline surveys
| Arm | Type | Receives |
|---|---|---|
| A&T- intensive | Experimental | Behavioral: MIYCN capacity building1. Capacity building will involve offsite training conducted by Vitamin Angels and short capsule trainings delivered by government staff 2. Supportive supervision will involve training and handholding of supervisors on use of job aids and mobile application 3. Strategic use of data will involve setting up processes to review key data, review meetings and short trainings on gap areas. 4. Engagement of Panchayati Raj Institutions (PRI) around convergence where PRI members will be equipped with job aids, including an App 5. Improved food supplements where THR offering for pregnant and lactating women and children 6 months and older will be revisited and improved solutions will be explored. |
| A&T-non intensive | No intervention | –Only receives standard government services |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mothers with children <2 years of age who are registered with the Anganwadi Center to receive services under the ICDS
- Pregnant women in first, second and third trimester who are registered with the Anganwadi Center to receive services under the ICDS
- Frontline health workers in the areas
- Supervisors/managers in the areas
- Key informants from the Panchayati Raj Institutions (PRI)
Key exclusion criteria (5 listed)
- Women who are not currently registered with the local Anganwadi center to receive ICDS services
- Age <18
- Pregnant women with severe illness or complications
- Mothers with severely ill children
- Mental health problems that make it difficult for the respondent to answer the questions
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 |
|---|---|---|
| MIYCN capacity buildingAlso: Strengthening Supportive Supervision (SS) of the ICDS & Health Supervisory Cadre, Strategic Use of Data (SUD) & Convergent Action Plan, Involving Panchayati Raj Members (PRIs) for improved Co-Coverage of nutrition services, THR offering refinement* MIYCN knowledge, skills, and motivation of FLWs * Supportive supervision * Decentralized programmatic decision-making using data * PRI member involvement * Availability of THR * IYCF knowledge and practices | Behavioural | A&T- intensive |
Primary outcome
Quality of delivery of health and nutrition interventions
Time frame: During pregnancy (about 9 months)
Proportion of beneficiaries receiving all ANC care items (weigh, blood sample taken, blood pressure measured, urine sample taken, abdomen checked),THR supplements and counseling.
Acceptability of reformulated take home ration by pregnant, lactating women and children
Time frame: During pregnancy (about 9 months) and up to 24 months postpartum
Total standardized scores of acceptability to five THR organoleptic properties (taste, smell, texture, color, difficulty of eating), with higher scores representing higher acceptability.
Use of reformulated take home ration by pregnant, lactating women and children
Time frame: During pregnancy (about 9 months) and up to 24 months postpartum
Proportion of beneficiaries who consumed THR during pregnancy, lactation or early childhood
Co-coverage of multiple interventions from across sectors
Time frame: During pregnancy (about 9 months) and up to 24 months postpartum
* For pregnant women: Proportion of pregnant women receiving at least 7 out of 14 interventions (>=4 ANC, received IFA, tetanus, weighed during ANC, breast feeding and cord counselling, received THR, health \& nutrition education, mosquito net, improved sanitation, clean cooking fuel, met ASHA worker at home, met AWW at home) * For mothers with children <2y: Proportion of mother-child pairs receiving at least 12 out of 24 interventions (≥ 4 ANC visits, received IFA, tetanus, deworming, weighed during ANC, breastfeeding and cord-care counselling, food supplementation, health and nutrition education, mosquito net, institutional birth, postnatal care for mothers and babies, postnatal food supplementation, postnatal health and nutrition education, counselling on child growth, deworming, pediatric IFA, Vitamin A supplementation, child weighing, home visits by AWW or ASHW, HHs with improved sanitation facility and cooking fuel)
5 secondary outcomes
MIYCN knowledge of FLWs
Time frame: In the 6 months prior to interview date
Supportive supervision
Time frame: In the 6 months prior to interview date
Decentralized programmatic decision-making using data
Time frame: In the 6 months prior to interview date
Panchayati Raj Members (PRI) member involvement
Time frame: In the 6 months prior to interview date
Mother IYCF knowledge and practices
Time frame: During pregnancy (about 9 months) and up to 24 months postpartum
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 2 May 2025.
- 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.
Phuong H Nguyen, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIYCN capacity building in people with Maternal Nutrition, run by International Food Policy Research Institute at 1 site in United States.
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 5 inclusion and 5 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 2 May 2025. 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 United States. 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.
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?
Quality of delivery of health and nutrition interventions (time frame: During pregnancy (about 9 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.