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

Part of paid clinical trials in San Diego, California.

Sponsor
San Diego State University
Study ID
NCT07088406
Status
Recruiting
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Conditions

  • Family Communication
  • Parenting Behavior
  • Physical Activity

Eligibility Criteria

Sex
FEMALE
Age
8 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Physical Activity Promotion — BEHAVIORAL
    The Conmigo Physical Activity intervention involves the delivery of ten weekly sessions led by YMCA Facilitators supported by Drs. Arredondo and Ayala, Project Manager and student research assistants. Mothers and daughters (8-11 years old) will be invited to participate in ten in-person 2-hour sessions on topics such as PA parenting, communication, goal setting, etc. Mothers and daughters participate together in most activities, with small group breakouts where just mothers or just daughters have separate activities during some sessions. Each session includes didactic teaching, skill building (e.g. role plays), interactive discussions, 30 minutes of group PA, and goal-setting/review of previous goals. Overall, the activities are designed to promote increased physical activity and mediators to PA (family communication, parenting strategies, etc.). Each cohort will include 12-15 mother-daughter dyads.
  • Healthy Eating — BEHAVIORAL
    The Healthy Eating intervention involves the delivery of 10 sessions by YMCA facilitators supported by Drs. Arredondo and Ayala, the Project Manager, and student research assistants. Mothers and daughters (8-11 years old) will be invited to participate in 10 2-hour in-person sessions that include both large and small group activities. Overall, the activities are designed to promote engagement in dietary behavioral strategies and parenting strategies across contexts and settings to promote fruit, vegetable and fiber consumption. Large and small groups activities include goal setting, implementation planning, homework activities, and focused discussion on mediators (e.g., family communication, parenting strategies) and moderators (e.g. acculturation). Each cohort will include 12-15 mother-daughter dyads.

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
432 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Physical Activity Intervention
    10-week PA promotion program
  • Active Comparator: Healthy Eating Intervention (attention control program)
    10-week health eating intervention

Primary Outcome Measure

Change in daughters' objective PA [ Time Frame: From enrollment to 3 months, 9 months, and 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Diego State UniversitySan DiegoCalifornia92123
Elva Arredondo
[email protected]
(619) 594-3481

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By research site
San Diego State University· San Diego, CA

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