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Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

Primary Purpose

Polio

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Maternal dietary diversity
Diet diversity in complementary feeding
Exclusive Breast Feeding
Community mobilization
Capacity Building
Use of existing platforms VHSND
Strategic use of data
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Polio focused on measuring 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

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • FHI Solutions LLC, Alive & Thrive

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental area PCI

Control area PCI

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Timely Introduction of Complementary Feeding
Percentage of children 6-23 months of age who were initiated with complementary feeding in their seventh month.

Full Information

First Posted
November 29, 2017
Last Updated
April 29, 2019
Sponsor
FHI 360
Collaborators
International Food Policy Research Institute, Project Concern International India
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1. Study Identification

Unique Protocol Identification Number
NCT03368885
Brief Title
Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI
Official Title
Evaluation of Integrating Selected MIYCN Interventions in Existing Polio Eradication Platform of Project Concern International (PCI) in UP
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
December 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
International Food Policy Research Institute, Project Concern International India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental area PCI
Arm Type
Experimental
Arm Description
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
Arm Title
Control area PCI
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Maternal dietary diversity
Intervention Description
Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition
Intervention Type
Other
Intervention Name(s)
Diet diversity in complementary feeding
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exclusive Breast Feeding
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Community mobilization
Intervention Description
Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding
Intervention Type
Other
Intervention Name(s)
Capacity Building
Intervention Description
Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years
Intervention Type
Other
Intervention Name(s)
Use of existing platforms VHSND
Intervention Description
Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding
Intervention Type
Other
Intervention Name(s)
Strategic use of data
Intervention Description
Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs
Primary Outcome Measure Information:
Title
Dietary Diversity in Maternal Nutrition
Description
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.
Time Frame
12 months
Title
Minimum Dietary Diversity in Complementary Feeding
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Timely Introduction of Complementary Feeding
Description
Percentage of children 6-23 months of age who were initiated with complementary feeding in their seventh month.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Das, MPS
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
FHI Solutions LLC, Alive & Thrive
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

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