Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health (K01)

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

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: Sumadhur Aarambha

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Nawalparasi, Nepal
    • Community Based

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main study; There is only 1 arm because this is a feasibility and acceptability pilot.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance and Attrition of Participants	Proportion of meetings that respondents reported that they attend, combined with the attrition rate	4 months
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DiamondSmithK01; K01HD086281 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will not share IPD with other researchers that has any identifiable information. Unidentified data will be shared with research analysts who have been included on our IRB and have human subjects training.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No