CClinicalTrials.gg
CompletedNCT04383847K01Updated Apr 2, 2025

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

An interventional study of Sumadhur Aarambha in Health Knowledge, Attitudes, Practice, sponsored by University of California, San Francisco. Completed at 1 site in Nepal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Health Knowledge, Attitudes, Practice
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Under 18
  • not recently married
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Main study

    There is only 1 arm because this is a feasibility and acceptability pilot.

    Behavioral: Sumadhur Aarambha

Interventions

  • BehavioralSumadhur 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.

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What researchers measure

Primary outcomes

  1. Attendance and Attrition of Participants

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

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Community based
    Nawalparasi, Nepal
08

References and documents

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. PubMed 35387647 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04383847
Lead sponsor
University of California, San Francisco
Collaborators
Center for Research on Environment, Health and Population Activities, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
May 12, 2020
Start date
Feb 1, 2021
Primary completion
Jul 1, 2021
Completion
Oct 1, 2021
Last update
Apr 2, 2025

Study contacts

Nadia G Diamond-Smith, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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