Physical ActivityNCT07088406
A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
A study testing Physical Activity Promotion and Healthy Eating in people with Physical Activity and Family Communication, run by San Diego State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Family Communication, Parenting Behavior
- What is being tested?
- Physical Activity Promotion and Healthy Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Schneider, MPH, MA contact
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92123
Elva Arredondo, (619) 594-3481, earredon@sdsu.edu
About this study
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
Read more
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.
Read the detailed description
Fewer Latina girls in the United States (US) meet current physical activity (PA) guidelines, especially those from lower-income and less-acculturated backgrounds-contributing to long-standing health disparities. The pre-pubertal phase (ages 8-11) represents a critical window for PA interventions to prevent the sharp decline in activity levels that typically occurs during adolescence.
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:
- Test the effectiveness of Conmigo in increasing girls' MVPA over time;
- Examine individual (e.g., mothers' MVPA) and family-level (e.g., communication, parenting practices) mechanisms and their bidirectional influences on behavior change;
- 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
- Physical Activity, Family Communication, Parenting Behavior
- Being tested
- Physical Activity Promotion, Healthy Eating
- Keywords
- Physical Activity, Conmigo, Mother-daughter, Latina, Multilevel Intervention, healthy eating, fruit and vegetable intake, parenting, YMCA facilitators
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity PromotionBehavioural
Also called Conmigo
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 EatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | 10-week PA promotion program Receives: Behavioral: Physical Activity Promotion |
| Healthy Eating Intervention (attention control program) | Active comparator | 10-week health eating intervention Receives: Behavioral: Healthy Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 3 months, 9 months, and 15 months
Secondary outcomes (4)
Change in Mother-daughter communication
Completed by Mothers; assessed by Parent Adolescent Communication Scale (PACS) -Open Family Communication Domain. 10 items on a 5-point likert scale of strongly disagree to strongly agree. Sum total score ranges from 10-50, with 50 representing more open (better) mother-daughter communication.
Measured: From enrollment to 3 months, 9 months, and 15 months
Change in Physical Activity Parenting Strategies
Completed by mothers; assessed with two domains (Nondirective support and Guided Choice) of the Physical Activity Parenting Practices (PAPP) scale which assesses mothers' use of parenting strategies that promote physical activity (PA) among 5-12 year old children. Nondirective support is a 10-item scale; guided choice is a short-version 4-item scale. Participants respond on a 5-point likert scale of frequency which is scored 0-4 per item and sum totaled. Nondirective support subscores range from 0-40; Guided choice subscores range from 0-16. The total combined score from both domains ranges from 0-56 with a higher score meaning more frequent use of PA-promoting parenting strategies.
Measured: From enrollment to 3 months, 9 months, and 15 months
Change in Daughters' Dietary Intake
Completed by daughters (with mother's assistance); Block Yesterday food screener. This screener assesses children's intake by food group; the focus is on intake of fruit and fruit juices, vegetables, potatoes, whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars", glycemic load and glycemic index. A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Screeners are externally analyzed by Nutrition Quest (https://www.nutritionquest.com/) with outcomes measured in number of servings consumed.
Measured: From enrollment to 3 months
Change in Mother's Physical Activity
Change in mothers' minutes per day of accelerometer-assessed moderate-to-vigorous physical activity; worn for at least four 10+ hour days.
Measured: From enrollment to 3 months, 9 months, and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start21 Aug 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088406
- Sponsor's protocol ID
- 1R01CA292783
- Other IDs
- 1R01CA292783-01
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data and resources generated by the study will include: (1) deidentified demographic and survey data; (2) physical activity tracking using accelerometers; (3) anthropometrics including height and weight; (4) study protocols (including analysis plans and consent forms); (6) training protocols; and (7) intervention materials. Codebooks and data collection instruments will also be made available to facilitate the interpretation of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas
- ClinicalTrials.gov ID
- NCT07088406
- Acronym / sponsor ID
- 1R01CA292783
- Conditions
- Physical Activity, Family Communication, Parenting Behavior
- Keywords
- Physical Activity, Conmigo, Mother-daughter, Latina, Multilevel Intervention, healthy eating, fruit and vegetable intake, parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fewer Latina girls in the United States (US) meet current physical activity (PA) guidelines, especially those from lower-income and less-acculturated backgrounds-contributing to long-standing health disparities. The pre-pubertal phase (ages 8-11) represents a critical window for PA interventions to prevent the sharp decline in activity levels that typically occurs during adolescence.
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:
- Test the effectiveness of Conmigo in increasing girls' MVPA over time;
- Examine individual (e.g., mothers' MVPA) and family-level (e.g., communication, parenting practices) mechanisms and their bidirectional influences on behavior change;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Physical Activity Promotion10-week PA promotion program |
| Healthy Eating Intervention (attention control program) | Active comparator | Behavioral: Healthy Eating10-week health eating intervention |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity PromotionAlso: ConmigoThe 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. | Behavioural | Physical Activity Intervention |
| Healthy EatingThe 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. | Behavioural | Healthy Eating Intervention (attention control program) |
Primary outcome
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.
4 secondary outcomes
Change in Mother-daughter communication
Time frame: From enrollment to 3 months, 9 months, and 15 months
Change in Physical Activity Parenting Strategies
Time frame: From enrollment to 3 months, 9 months, and 15 months
Change in Daughters' Dietary Intake
Time frame: From enrollment to 3 months
Change in Mother's Physical Activity
Time frame: From enrollment to 3 months, 9 months, and 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Our data and resources generated by the study will include: (1) deidentified demographic and survey data; (2) physical activity tracking using accelerometers; (3) anthropometrics including height and weight; (4) study protocols (including analysis plans and consent forms); (6) training protocols; and (7) intervention materials. Codebooks and data collection instruments will also be made available to facilitate the interpretation of study findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Schneider, MPH, MA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Promotion and Healthy Eating in people with Physical Activity and Family Communication, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elva Arredondo, PhD ((619) 594-3481, earredon@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daughters' objective PA (time frame: From enrollment to 3 months, 9 months, and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.