Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

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.

Study Overview

• Status: Completed
• Conditions: Polio
• Intervention / Treatment: 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

Detailed Description

The experimental arm will receive the following interventions:

1. 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).
2. 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.
3. 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.
4. 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 Type: Interventional
• Enrollment (Actual): 2590
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110001
      • FHI Solutions LLC, Alive & Thrive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental area PCI; 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 diversity; Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition; Other: Diet diversity in complementary feeding; 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; Other: Exclusive Breast Feeding; 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; Other: Community mobilization; Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding; Other: Capacity Building; Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years; Other: Use of existing platforms VHSND; Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding; Other: Strategic use of data; Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs
No Intervention: Control area PCI; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timely Introduction of Complementary Feeding	Percentage of children 6-23 months of age who were initiated with complementary feeding in their seventh month.	12 months

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: International Food Policy Research Institute; Project Concern International India
• Investigators: Principal Investigator: Preeti Das, MPS, FHI 360

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 24, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: 1101870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No