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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04383847
Other study ID # DiamondSmithK01
Secondary ID K01HD086281
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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