Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI

Polio Clinical Trial

Official title:

Evaluation of Integrating Selected MIYCN Interventions in Existing Polio Eradication Platform of Project Concern International (PCI) in UP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368885
• Other study ID #: 1101870
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 24, 2018

Study information

• Verified date: April 2019
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2590
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Polio

Intervention

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
• 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
• 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
• 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
• Capacity Building
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 VHSND
Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding
• Strategic use of data
Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs

Locations

Country	Name	City	State
India	FHI Solutions LLC, Alive & Thrive	New Delhi	Delhi

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	International Food Policy Research Institute, Project Concern International India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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