NCT03368885

Brief 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. The study includes awareness generation (regarding nutrition) through community mobilization, counseling and capacity building of community mobilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

November 29, 2017

Last Update Submit

April 29, 2019

Conditions

Keywords

MIYCN -Maternal Infant Young Child NutritionCGPP - Core Group Polio ProjectA&T- Alive and ThrivePCI- Project Concern InternationalUP- Uttar PradeshVHSNC -Village Health, Sanitation and Nutrition CommitteeCMC- Community Mobilization Coordinator

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    12 months

Secondary Outcomes (1)

  • Timely Introduction of Complementary Feeding

    12 months

Study Arms (2)

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

Other: Maternal dietary diversityOther: Diet diversity in complementary feedingOther: Exclusive Breast FeedingOther: Community mobilizationOther: Capacity BuildingOther: Use of existing platforms VHSNDOther: 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

Interventions

Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition

Experimental area PCI

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

Experimental area PCI

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

Experimental area PCI

Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding

Experimental area PCI

Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years

Experimental area PCI

Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding

Experimental area PCI

Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs

Experimental area PCI

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FHI Solutions LLC, Alive & Thrive

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Poliomyelitis

Interventions

Infant Nutritional Physiological PhenomenaCapacity Building

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Child Nutritional Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth Care Facilities Workforce and ServicesOrganization and AdministrationHealth Services AdministrationPandemic PreparednessDisaster PlanningDisastersEnvironmentEnvironment and Public HealthCommunicable Disease ControlPublic Health PracticePublic Health

Study Officials

  • Preeti Das, MPS

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 11, 2017

Study Start

December 1, 2017

Primary Completion

December 24, 2018

Study Completion

December 24, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations