Clinical Trial

A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas

Recruiting
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Summary
The goal of this Cluster Randomized Control Trial (RCT) is to learn if the mother-daughter intervention titled "Conmigo" can increase Latina preadolescents' physical activity (PA). The main objectives of the study are: * To test the effectiveness of Conmigo on daughters' Moderate-to-Vigorous level PA (MVPA) over time * To evaluate individual (e.g. mothers' MVPA) and family level (e.g. mother-daughter communication) mechanisms of change and their bidirectional effects Researchers will compare the 10-week physical activity promotion intervention to a 10-week parallel intervention with emphasis on another health behavior (dietary intake) to see if there are differences in MVPA levels. We will enroll 216 Latina mother-daughter pairs at 18 elementary schools; each school will randomly receive the PA intervention or the control group program. Mothers and daughters will attend 10 weekly sessions (2 hours each) at their elementary school, led by YMCA staff. Informed by social cognitive theory and family systems theory, the PA intervention sessions target family-level correlates of physical activity such as PA promotion parenting strategies (monitoring, role-modeling, etc.) and mother-daughter communication. Participants in the intervention group engage in weekly PA during sessions, discuss different topics each week, and set goals and receive PA homework during the week. The investigators hypothesize that daughters participating in Conmigo will have higher minutes of device-assessed MVPA at M2 (post program), M3 (6 months post program), and M4 (12-months post program) compared to girls in the control condition.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-25.
Status change: Not Yet Recruiting → Recruiting 2025-09-24
Trial Details
NCT Number NCT07088406
Lead Sponsor San Diego State University
Collaborators: National Cancer Institute (NCI)
Conditions Physical Activity, Family Communication, Parenting Behavior
Enrollment 432 participants
Start Date 2025-08-21
Primary Completion 2029-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-30