Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

Not Applicable

Completed

• Conditions: Polio
• Interventions: 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

• Registration Number: NCT03368885
• Lead Sponsor: FHI 360

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:

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 Timeline

• Study First Submitted: 2017-11-29
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Primary Completion: 2018-12-24
• Study Completion: 2018-12-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2590

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental area PCI	Community mobilization	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
Experimental area PCI	Capacity Building	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
Experimental area PCI	Use of existing platforms VHSND	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
Experimental area PCI	Strategic use of data	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
Experimental area PCI	Maternal dietary diversity	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
Experimental area PCI	Diet diversity in complementary feeding	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
Experimental area PCI	Exclusive Breast Feeding	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

Primary Outcome Measures

Name	Time	Method
Dietary Diversity in Maternal Nutrition	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	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FHI Solutions LLC, Alive & Thrive; 🇮🇳 New Delhi, Delhi, India