Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health

Health Knowledge, Attitudes, Practice Clinical Trial

— K01  

Official title:

Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383847
• Other study ID #: DiamondSmithK01
• Secondary ID: K01HD086281
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To pilot test a group intervention for newly married women and their households to improve nutrition, pregnancy and delivery knowledge, and intrahousehold communication

Description:

Aim: To test the feasibility of an empowerment and food insecurity intervention for newly married women and others in their households to improve maternal and child health outcomes. The investigators will pilot an intervention consisting of groups of newly married women, their husbands and mothers-in-law. Each household will be enrolled for 4 months in weekly sessions. Topics discussed will include behavioral messaging crafted specifically for newly married households (including husbands and in-laws) to address the perceptions of different family members about food consumption, gender inequality, and the relationship between women's nutrition, food consumption, maternal health, and birth outcomes. Behavioral messaging at the household level: Based on findings from preliminary studies, key barriers to newly married women receiving needed nutrition/food and potential mechanisms to address those barriers were identified, as well as informational messages that could be used to address specific barriers. Particular attention was paid to how household dynamics and decision-making relate to gender inequality and food insecurity. Thirty randomly selected newly married households will be recruited to participate in testing the feasibility and acceptability of the intervention. Acceptability will be assessed from women, husbands, and mothers-in-law through surveys at the end of 4 months with questions on relevance to their needs, information gained, and interest in participating further. Enrollment and retention at 4 months will also be used to measure acceptability. Preliminary changes in knowledge, attitudes and behaviors will be assessed through a comparison of pre and post survey data. The investigators will also conduct semi structured interviews with 15 participants and 5 stakeholders. If necessary, the intervention will then be refined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• the household has a newly married couple (married in the last 3 months)
• a living mother-in-law
• both the woman and man being over the age of 18

Exclusion Criteria:

• Under 18
• not recently married

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
• Sumadhur Aarambha
Group intervention for newly married women, their husbands, and mothers-in-law with information mainly about nutrition, but also pre-pregnancy health, reproductive/pregnancy health and gender equality.

Locations

Country	Name	City	State
Nepal	Community based	Nawalparasi

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Center for Research on Environment Health and Population Activities (CREHPA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance and Attrition of Participants	Proportion of meetings that respondents reported that they attend, combined with the attrition rate	4 months
Primary	Participant Satisfaction	Proportion of respondents who state that they were satisfied with the intervention, answering "Very satisfied" or "satisfied" to a 5 point scale from very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied or very satisfied.	4 months