Clinical trial NCT04383847: Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health
Official title: Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Center for Research on Environment, Health and Population Activities
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study in 30 groups, pre post, no control
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance and Attrition of Participants
timeFrame: 4 months
measure: Participant Satisfaction
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nawalparasi
country: Nepal
facility: Community based
Study officials:
affiliation: University of California, San Francisco
name: Nadia G Diamond-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diamond-Smith N, Mitchell A, Cornell A, Dahal M, Gopalakrishnan L, Johnson M, Weiser S, Puri M. The development and feasibility of a group-based household-level intervention to improve preconception nutrition in Nawalparasi district of Nepal. BMC Public Health. 2022 Apr 6;22(1):666. doi: 10.1186/s12889-022-12980-w.