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Completed

NCT Number: NCT04383847

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community based

Nawalparasi, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sumadhur Aarambha

Behavioral

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.

Primary outcomes

  1. Attendance and Attrition of Participants

    Time frame: 4 months

    Proportion of meetings that respondents reported that they attend, combined with the attrition rate

  2. Participant Satisfaction

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Center for Research on Environment, Health and Population Activities
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: K01

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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