A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
NCT ID: NCT07088406
Last Updated: 2025-09-30
Study Results
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Basic Information
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RECRUITING
NA
432 participants
INTERVENTIONAL
2025-08-21
2029-08-31
Brief Summary
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* 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.
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Detailed Description
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To address this need, we will conduct a two-arm cluster RCT in 18 schools serving Latina girls to evaluate Conmigo, a multilevel, mother-daughter PA intervention. This trial builds on prior formative work and a successful R21 pilot feasibility study, which demonstrated promising increases in moderate-to-vigorous physical activity (MVPA) among Latina mother-daughter dyads following a 10-week intervention.
The current study will recruit and randomize 216 mother-daughter dyads (girls aged 8-11) to either the 10-week Conmigo intervention or an attention-control program of similar duration and structure focused on dietary intake. Both programs will be delivered by trained YMCA staff in partnership with participating schools. Using a Hybrid Type 1 effectiveness-implementation design, we will assess both the effectiveness of the intervention and key implementation outcomes to inform future scale-up.
At the individual level, girls will participate in PA sessions and learn behavioral strategies to support daily PA habits. At the family level, mothers will also attend the intervention sessions and receive additional instruction focused on PA parenting practices and strengthening mother-daughter communication. Mothers are critical to shaping their daughters' PA through modeling, creating active opportunities, limiting sedentary behaviors, and providing encouragement and support. Importantly, parent-child influences are bidirectional meaning that daughters also shape parenting practices and mothers' own PA behaviors through their needs and feedback.
Girls' PA will be objectively measured using accelerometer devices worn by mothers and daughters at baseline, 3, 9, and 15 months. Secondary outcomes include PA parenting practices and mother-daughter communication, as well as mothers' PA. Focus groups and interviews with participants, school personnel, YMCA staff, and community partners will identify facilitators and barriers to implementation, mechanisms of change, and strategies for wider dissemination.
Specific Aims are to:
1. Test the effectiveness of Conmigo in increasing girls' MVPA over time;
2. Examine individual (e.g., mothers' MVPA) and family-level (e.g., communication, parenting practices) mechanisms and their bidirectional influences on behavior change;
3. Use qualitative and quantitative methods to evaluate implementation outcomes, including feasibility, fidelity, and scalability across community settings.
By partnering with 9 YMCAs and 18 schools, Conmigo aims to strengthen community capacity to deliver culturally tailored, evidence-based PA interventions. This work addresses critical gaps in the literature by focusing on Latina mother-daughter dyads, incorporating objective outcome measures and long-term follow-up, and advancing implementation science within community health promotion efforts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Physical Activity Intervention
10-week PA promotion program
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.
Healthy Eating Intervention (attention control program)
10-week health eating intervention
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 8-11
* not currently meeting CDC's 2018 PA guidelines (60 min MVPA/day)
* attends an elementary school enrolled in the study
* speaks English or Spanish
* 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
* cognitive impairment affecting participation,
* inability for mother to provide informed consent or daughter to provide assent in English or Spanish
8 Years
65 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
San Diego State University
OTHER
Responsible Party
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Locations
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San Diego State University
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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