- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383847
Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health (K01)
November 2, 2021 updated by: University of California, San Francisco
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nawalparasi, Nepal
- Community Based
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Main study
There is only 1 arm because this is a feasibility and acceptability pilot.
|
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
Time Frame: 4 months
|
Proportion of meetings that respondents reported that they attend, combined with the attrition rate
|
4 months
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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.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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