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Father-Inclusive Parenting Intervention in Mwanza, Tanzania

StatusCompleted
PhaseNot applicable
Started2025-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Document Section v4
Trial completed
2026-05-01
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures v3
Primary completion date2026-01-31→2026-07-31
Completion date2026-01-31→2026-07-31
Secondary endpointsdetails revised at 10 of 10 entries
Study description+628 characters
[...] ther relevant stakeholders across the intervention villages. The primary endpoint for the trial will be the endline assessment, or 6 months post-baseline. Following completion of the core Familia Bora program, intervention villages will be re-randomized (stratified by district) to receive either a 3-month booster extension or no additional intervention. The [...]
2025-10-01
Study Status, Outcome Measures v2
Re-verified, no change to tracked fields
2025-09-28
Recruiting→Active, Not Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 768→confirmed 792
Secondary endpoints9 to 10 entries
Child dietary diversity
Study description-186 characters
[...] rvention ("Familia Bora"). The study will be implemented in 3233 villages across Misungwi and Sengerema districts in Mwanza [...] the villages will be randomly assigned to the intervention (17 villages) versus control group (16 villages) with stratification by district. The program will train com [...] ient community location on a weekly basis for approximately sixfive months. In addition to the group sessions, CHWs will also conduct monthly home visits to reinforce key messages and provide additional individualized support to families. In total, the trial will aim to enroll at least 384396 couples with y [...] [...]
Study sitesdetails revised at 2 of 2 sites
2025-06-09
Original filing
This cluster-randomized controlled trial aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Additionally, this study aims to assess the program's implementation and identify factors influencing its quality and effectiveness. Trained community health workers will deliver the program by facilitating weekly peer group sessions in their villages. Twelve couples with a child under two years old will be enrolled in each village. The program will cover various topics, including responsive caregiving, positive discipline, stress management, healthy couples' communication, nutrition, and gender.
Trial Details
NCT Number NCT07025447
Lead Sponsor Emory University
Collaborators: Tanzania Home Economics Organization, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Parents
Enrollment 792 participants
Start Date 2025-05-21
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-08