Recruiting

Conmigo

Sponsor:

San Diego State University

Code:

NCT07088406

Conditions

Physical Activity

Family Communication

Parenting Behavior

Eligibility Criteria

Sex: Female

Age: 8 - 65

Healthy Volunteers: Accepted

Interventions

Physical Activity Promotion

Healthy Eating

Study Details

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

Study ID

NCT07088406

Start date

Aug 21, 2025

Status verified date

Sep, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 8 - 65

Healthy Volunteers: Accepted

Inclusion Criteria (DAUGHTER):

  • 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

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

Study Design

Enrollment

432 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Physical Activity Intervention

10-week PA promotion program

active comparator: Healthy Eating Intervention (attention control program)

10-week health eating intervention

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elva Arredondo, PhD

(619) 594-3481earredon@sdsu.edu

Jennifer Schneider, MPH, MA

jlbeckner@sdsu.edu

Locations

San Diego State University

Recruiting

San Diego, California, United States, 92123

Contacts

Elva Arredondo

(619) 594-3481earredon@sdsu.edu

More Information

Sponsor

San Diego State University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego State University on 2025-09-30.