NCT07088406 · San Diego State University
A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
What this study is about
The goal of this Cluster randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Physical Activity Promotion
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.
BEHAVIORAL
Healthy Eating
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.
Primary outcome measures
Change in daughters' objective PA
Time frame: From enrollment to 3 months, 9 months, and 15 months
Change in daughters' accelerometer-assessed minutes per day of moderate-to-vigorous physical activity (MVPA); worn for at least four 10+ hour days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (DAUGHTER):
- Self-identifying as Latina
- not currently meeting CDC's 2018 PA guidelines (60 min MVPA/day)
- attends an elementary school enrolled in the study
- speaks English or Spanish Inclusion Criteria (MOTHER):
- Self-identifying as Latina
- primary female caregiver (living with her ≥4 days/week) of the daughter
- speaks English or Spanish
- both Mother \& Daughter can attend weekly program activities for 10 weeks, and intend to stay in the area for the study's duration.
Exclusion criteria
- either Mother or Daughter has a health condition that precludes them from doing PA
- cognitive impairment affecting participation,
- inability for mother to provide informed consent or daughter to provide assent in English or Spanish
Where
- San Diego, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations