No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
8 – 65
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
432 (estimated)
Sponsor
San Diego State University · Other
Who this trial is looking for
This trial is looking for Latina girls aged 8-11 and their mothers to participate in a physical activity program. Together, they will attend weekly sessions for 10 weeks to engage in activities and discussions that promote exercise.
Are You a Good Fit for This Trial?
You may be able to join if
I identify as Latina
I am aged 8-11
I don’t meet the recommended physical activity guidelines
I attend an elementary school involved in the study
I can speak English or Spanish
I live with my mother at least 4 days a week
My mother speaks English or Spanish
Both my mother and I can attend the program for 10 weeks
You may not be able to join if
I have a health condition that prevents me from exercising
I have cognitive impairment that affects my participation
My mother cannot provide consent in English or Spanish
I cannot provide assent in English or Spanish
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-daug…
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.
Trial Locations
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Status
Eligibility Criteria
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 ca…
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
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