PolioNCT03368885
Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI
A study testing Maternal dietary diversity, Diet diversity in complementary feeding and Exclusive Breast Feeding in people with Polio, run by FHI 360 at 1 site in India.
Trial summary
The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-23 months) for exact 12 months. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polio
- What is being tested?
- Maternal dietary diversity, Diet diversity in complementary feeding and Exclusive Breast Feeding
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,590 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2017to 24 Dec 2018
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For Community
- • Women aged 15-49 years
- Willing and able to provide consent
- Women in 2nd and 3rd trimester of pregnancy and / or
- Women with children aged 6-23 months For CMC
- Women aged 18+
- Currently appointed a CMC in a selected HRA
- Willing and able to provide consent
Who cannot join
- Women in first trimester of pregnancy
- Women whose index child (youngest child, between 6-23 months of age) is not her biological child
- Women whose index child is not currently living with the mother
Trial locations and contacts
1 site in 1 country.
India1 site
FHI Solutions LLC, Alive & Thrive
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Evaluation of Integrating Selected MIYCN Interventions in Existing Polio Eradication Platform of Project Concern International (PCI) in UP
The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-23 months) for exact 12 months. The study includes awareness generation (regarding nutrition) through community mobilization, counseling and capacity building of community mobilization.
Read the detailed description
The experimental arm will receive the following interventions:
- Interpersonal communication (IPC) to reach target women (Women in their 2nd or 3rd trimester of pregnancy and women with 6-23 months old child) to deliver messages on maternal nutrition package and complementary feeding through home visits made by Community Mobilization Coordinator (CMC).
- Expanded community mobilization involving key influencers in family like husbands and mothers -in-law and community opinion leaders, religious leaders, Village Health Sanitation and Nutrition Committee (VHSNC) members. The aims are to improve awareness, shift norms and perceptions, engage husbands and local opinion leaders to promote healthy behaviour practices related to maternal nutrition and complementary feeding.
- Strategic use of data to design a context-specific program and track the progress of the program with regards to impact on social norms and behaviors at household/community level and demonstrate the feasibility of integrating select MIYCN interventions in polio eradication platforms.
- Convergence: The convergence will mainly focus on three Cs - maintain consistency, avoid conflict and enhance cooperation. This will aid in passing consistent MIYCN messages to the target community and ensure effective teamwork, collaboration and mutual support
- Conditions
- Polio
- Being tested
- Maternal dietary diversity, Diet diversity in complementary feeding, Exclusive Breast Feeding, Community mobilization, Capacity Building
- Keywords
- MIYCN -Maternal Infant Young Child Nutrition, CGPP - Core Group Polio Project, A&T- Alive and Thrive, PCI- Project Concern International, UP- Uttar Pradesh, VHSNC -Village Health, Sanitation and Nutrition Committee, CMC- Community Mobilization Coordinator
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal dietary diversityOther
Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition
Diet diversity in complementary feedingOther
Counsel mothers of children of 6-23 months on diet diversity in complementary feeding by demonstration during home-visits and seek support from father and family members
Exclusive Breast FeedingOther
Counselling on exclusive breast feeding among children under 6 months-Provide information to mothers of children of 3-6 months for exclusive breast feeding through home visits, and mothers meetings
Community mobilizationOther
Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding
Capacity BuildingOther
Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years
Use of existing platforms VHSNDOther
Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding
Strategic use of dataOther
Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs
| Study group | Role | What they receive |
|---|---|---|
| Experimental area PCI | Experimental | In this arm, in addition to the standard care for Polio eradication program activities of CGPP project, the following interventions are added:
Maternal dietary diversity; Diet diversity in complementary feeding; Exclusive breast feeding; Community mobilization; Capacity building; Convergence;Use of existing platforms VHSND; Strategic Use of Data Receives: Other: Maternal dietary diversity; Other: Diet diversity in complementary feeding; Other: Exclusive Breast Feeding; Other: Community mobilization; Other: Capacity Building; Other: Use of existing platforms VHSND; Other: Strategic use of data |
| Control area PCI | No intervention | This arm will receive standard care with respect to Polio eradication program activities of CGPP such as awareness generation around Polio and routine immunization, hand washing and sanitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Diversity in Maternal Nutrition
Percentage of Women in their 2nd or 3rd trimester of pregnancy from targeted households who consumed food from at least 5 specific nutrient rich food groups out of 10 defined food groups.
Measured: 12 months
Minimum Dietary Diversity in Complementary Feeding
Percentage of children 6-23 months of age from targeted households who receive foods from 4 or more food groups (separately for breastfed and non-breastfed children)
Measured: 12 months
Secondary outcomes (1)
Timely Introduction of Complementary Feeding
Percentage of children 6-23 months of age who were initiated with complementary feeding in their seventh month.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completion24 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,590 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- International Food Policy Research Institute, Project Concern International India
- Responsible party
- Sponsor
- Investigators
- Preeti Das, MPS, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368885
- Sponsor's protocol ID
- 1101870
- Status last verified
- Apr 2019
- First submitted
- 29 Nov 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integrating Selected MIYCN Interventions in Existing Polio Eradication Platform of Project Concern International (PCI) in UP
- ClinicalTrials.gov ID
- NCT03368885
- Acronym / sponsor ID
- 1101870
- Conditions
- Polio
- Keywords
- MIYCN -Maternal Infant Young Child Nutrition, CGPP - Core Group Polio Project, A&T- Alive and Thrive, PCI- Project Concern International, UP- Uttar Pradesh, VHSNC -Village Health, Sanitation and Nutrition Committee, CMC- Community Mobilization Coordinator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,590 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- International Food Policy Research Institute, Project Concern International India
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 11 Dec 2017 (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.
The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-23 months) for exact 12 months. The study includes awareness generation (regarding nutrition) through community mobilization, counseling and capacity building of community mobilization.
Detailed description
The experimental arm will receive the following interventions:
- Interpersonal communication (IPC) to reach target women (Women in their 2nd or 3rd trimester of pregnancy and women with 6-23 months old child) to deliver messages on maternal nutrition package and complementary feeding through home visits made by Community Mobilization Coordinator (CMC).
- Expanded community mobilization involving key influencers in family like husbands and mothers -in-law and community opinion leaders, religious leaders, Village Health Sanitation and Nutrition Committee (VHSNC) members. The aims are to improve awareness, shift norms and perceptions, engage husbands and local opinion leaders to promote healthy behaviour practices related to maternal nutrition and complementary feeding.
- Strategic use of data to design a context-specific program and track the progress of the program with regards to impact on social norms and behaviors at household/community level and demonstrate the feasibility of integrating select MIYCN interventions in polio eradication platforms.
- Convergence: The convergence will mainly focus on three Cs - maintain consistency, avoid conflict and enhance cooperation. This will aid in passing consistent MIYCN messages to the target community and ensure effective teamwork, collaboration and mutual support
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental area PCI | Experimental | Other: Maternal dietary diversity, Other: Diet diversity in complementary feeding, Other: Exclusive Breast Feeding, Other: Community mobilization, Other: Capacity Building, Other: Use of existing platforms VHSND, Other: Strategic use of dataIn this arm, in addition to the standard care for Polio eradication program activities of CGPP project, the following interventions are added: Maternal dietary diversity; Diet diversity in complementary feeding; Exclusive breast feeding; Community mobilization; Capacity building; Convergence;Use of existing platforms VHSND; Strategic Use of Data |
| Control area PCI | No intervention | –This arm will receive standard care with respect to Polio eradication program activities of CGPP such as awareness generation around Polio and routine immunization, hand washing and sanitation |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- For Community
- • Women aged 15-49 years
Key exclusion criteria (3 listed)
- Women in first trimester of pregnancy
- Women whose index child (youngest child, between 6-23 months of age) is not her biological child
- Women whose index child is not currently living with the mother
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 |
|---|---|---|
| Maternal dietary diversityCounsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition | Other | Experimental area PCI |
| Diet diversity in complementary feedingCounsel mothers of children of 6-23 months on diet diversity in complementary feeding by demonstration during home-visits and seek support from father and family members | Other | Experimental area PCI |
| Exclusive Breast FeedingCounselling on exclusive breast feeding among children under 6 months-Provide information to mothers of children of 3-6 months for exclusive breast feeding through home visits, and mothers meetings | Other | Experimental area PCI |
| Community mobilizationEngagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding | Other | Experimental area PCI |
| Capacity BuildingCapacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years | Other | Experimental area PCI |
| Use of existing platforms VHSNDConvergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding | Other | Experimental area PCI |
| Strategic use of dataStrategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs | Other | Experimental area PCI |
Primary outcome
Dietary Diversity in Maternal Nutrition
Time frame: 12 months
Percentage of Women in their 2nd or 3rd trimester of pregnancy from targeted households who consumed food from at least 5 specific nutrient rich food groups out of 10 defined food groups.
Minimum Dietary Diversity in Complementary Feeding
Time frame: 12 months
Percentage of children 6-23 months of age from targeted households who receive foods from 4 or more food groups (separately for breastfed and non-breastfed children)
1 secondary outcome
Timely Introduction of Complementary Feeding
Time frame: 12 months
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 1 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Polio
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
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.
Preeti Das, MPS principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal dietary diversity, Diet diversity in complementary feeding and Exclusive Breast Feeding in people with Polio, run by FHI 360 at 1 site in India.
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 8 inclusion and 3 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 1 May 2019. 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 India. 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?
Dietary Diversity in Maternal Nutrition (time frame: 12 months). The study lists 2 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 1 May 2019.