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

NCT07088406 | Recruiting DMC

• 2 other identifiers: 1R01CA2927831R01CA292783-01
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity; Family Communication; Parenting Behavior

Keywords

Physical Activity; Conmigo; Mother-daughter; Latina; Multilevel Intervention; healthy eating; fruit and vegetable intake; parenting; YMCA facilitators

Outcome Measures

Primary Outcomes (1)

• Change in daughters' objective PA

  Change in daughters' accelerometer-assessed minutes per day of moderate-to-vigorous physical activity (MVPA); worn for at least four 10+ hour days.

  From enrollment to 3 months, 9 months, and 15 months

Secondary Outcomes (4)

• Change in Mother-daughter communication

  From enrollment to 3 months, 9 months, and 15 months

• Change in Physical Activity Parenting Strategies

  From enrollment to 3 months, 9 months, and 15 months

• Change in Daughters' Dietary Intake

  From enrollment to 3 months

• Change in Mother's Physical Activity

  From enrollment to 3 months, 9 months, and 15 months

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

10-week PA promotion program

Behavioral: Physical Activity Promotion

Healthy Eating Intervention (attention control program)

ACTIVE COMPARATOR

10-week health eating intervention

Behavioral: Healthy Eating

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.

Also known as: Conmigo

Physical Activity Intervention

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.

Healthy Eating Intervention (attention control program)

Eligibility Criteria

• Age: 8 Years - 65 Years
• Gender Eligibility Details: Mothers and daughters self-identifying as women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identifying as Latina
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Elva Arredondo, PhD

CONTACT

(619) 594-3481; earredon@sdsu.edu

Jennifer Schneider, MPH, MA

CONTACT

jlbeckner@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data collection team is masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 28, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available within 6 months of the study end and primary outcome paper publication. The data will be available for a minimum of 7 year following completion of the study in the repository.
• Access Criteria: The scientific data and metadata from this project will be archived in the SDSU Institutional Repository and others, ensuring long-term preservation and accessibility. We will also share study protocols and training materials for community-based physical activity interventions and assessments. Some materials will be openly accessible through SDSU-affiliated portals, while deidentified datasets will be released upon request under a data-sharing agreement that provides for commitment to: (1) using the data only for research purposes, (2) to securing the data, and (3) to destroying or returning the data after analyses are completed. Data and intellectual property generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy.

Locations

US (1)