- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06596902
Promoting Physical Activity and Fitness Among Underserved Latino Families Living in U.S.-Mexico Border Regions (AFL)
September 30, 2025 updated by: San Diego State University
This study has the goal to increase physical activity and fitness among Latinos in San Diego, California and Mexicali, Baja California (U.S.-Mexico border) since these cities have similar diseases such as high rates of heart disease and obesity.
Therefore there is a need to have physical activity programs for children and their families.
We will collaborate with community centers to have this program available.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The U.S. and Mexico share similar population disease patterns such as high rates of chronic diseases (e.g.,heart disease and obesity).
Individuals residing in border regions often travel back and forth between the U.S. and Mexico, which exposes them to both different and similar obesogenic, socio-cultural, and physical environments.
This frequent transnational interaction has led researchers to classify border cities as one region that should be studied as a whole.
As such, it is important to systematically study border populations and develop effective interventions and public policy for this region.
This study will test the efficacy and sustainability of a 12-month family-centered behavioral cluster randomized intervention, Athletes for Life (AFL), plus a 1-year active sustainability phase in community recreation centers in San Diego, California (U.S.) and Mexicali, Baja California (Mexico).
This study will also assess intervention implementation outcomes, including program acceptability and feasibility by families and community recreation center staff.
A total of 8 community recreation centers and 290 parent/child dyads (4 in San Diego and 4 in Mexicali) will be randomized to either a control group consisting of standard recreation center classes (delivered by regular recreation center staff) or an experimental group consisting of the multilevel AFL behavioral intervention (delivered by study staff).
This study aims to increase total habitual physical activity (PA) and cardiovascular fitness (CVF) in a U.S.-Mexico transborder population that experiences disproportionately high rates of obesity.
We will harness our research team's extensive experience in developing multi-level interventions to promote behavior change among Latinos, and leverage a strong community-academic collaboration that maximizes community impact and sustainability.
The long-term goal of this project is to reduce cardiovascular disease and cardiometabolic risk factors among underserved children and their families in the US-Mexico border region.
This research will provide novel empirical evidence for the efficacy, scalability, and sustainability of a multilevel fitness- and lifestyle-oriented family approach delivered in collaboration with community centers among underserved Latino families in the U.S.-Mexico border region.
Study Type
Interventional
Enrollment (Estimated)
290
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Noe C Crespo, MS, MPH, PhD
- Phone Number: 619-594-2395
- Email: ncrespo@sdsu.edu
Study Contact Backup
- Name: Bianca Vargas-Tequida, MS
- Phone Number: 619-514-5770
- Email: bvargastequida@sdsu.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92182
- Recruiting
- San Diego State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- parents aged ≥18 years
- children aged 6-11 years
- living in the target community (within 5 miles of one of targeted community centers)
Exclusion Criteria:
- for the parent or child are presence of a medical or physical condition that is contraindicated to participating in sports/exercise (e.g., negative score on the Physical Activity Readiness Questionnaire (PAR-Q)).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Program
The 12-month intervention will progressively increase in intensity & complexity to teach parents/children more complex sports skills & behavioral techniques, & to prepare them to become future team leaders for nutrition education and sports sessions.
In addition, the family Olympics events will take place after every 3-month to reinforce progression, social support, & progressive improvements: Phase 1: Beginner (months 0-3) will focus on introductory concepts & basic sports skills & will focus on establishing consistent behavioral patterns & social support.
Phase 2: Intermediate (months 4-6) will begin to introduce slightly more complex nutrition & behavioral concepts, increase difficulty of sport skills, & reinforce behavioral patterns from phase 1. Phase 4: Advanced (months 10-12) will teach parents & children advanced sports skills & nutrition knowledge so that they may become team leaders to help implement future activity sessions and nutrition education sessions.
|
The 12-month intervention will progressively increase in intensity and complexity to teach parents/children more complex sports skills and behavioral techniques, to prepare them to become future team leaders for nutrition education and sports sessions.
In addition, the family Olympics events will take place after every 3-month to reinforce progression, social support; progressive improvements: Phase 1: Beginner (months 0-3) will focus on introductory concepts and basic sports skills and will focus on establishing consistent behavioral patterns and social support.
Phase 2: Intermediate (months 4-6) will begin to introduce slightly more complex nutrition behavioral concepts and increase difficulty of sport skills, and reinforce behavioral patterns from phase 1. Phase 4: Advanced (months 10-12) will teach parents and children advanced sports skills ; nutrition knowledge so that they may become team leaders to help implement future activity sessions and nutrition education sessions.
|
|
No Intervention: Control Group
Centers that are randomly assigned to the control group will continue with regularly schedule programing and activities.
Families recruited from control centers will be allowed to take part in all the programs offered at the recreation centers, with exception to the AFL program since it will not be offered at those centers.
Control group families will also receive publicly available information regarding the benefits of PA and strategies to become physically active (e.g., CDC PA guidelines websites & handbook).
12-month sustainability phase will involve assessments at the organizational and individual levels.
At the organizational level, we will examine the number of AFL sessions held at each recreation center and document the number of phone consultations, length of calls, and barriers addressed.
At the individual level, we will examine the number of minutes of adult and child habitual PA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Physical Activity (PA)
Time Frame: 1 year
|
Total PA (mean minutes/day) in children will be measured objectively with a wrist-worn ActiGraph GT9X Link (Pensacola, United States).
According to recommended procedures[84], children will be asked to wear the accelerometer continuously on their non-preferred wrist for seven days.
Parents will be provided with a sleep diary where they will record their child's wake/sleep times and periods of non-wear.
Child and adult CVF performance will be measured via the 1-mile run/walk time in seconds at a local park (usually adjacent to the Community Centers).
Study staff will utilize stop watches to collect total mile run time in seconds and record the time in each participant's record log.
In addition, a measurement staff will run/walk along with each child participant and provide them with verbal encouragement to put forth their best effort.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation
Time Frame: 1 year
|
Will be assessed at multiple levels: participant/families, research team (including Promotores), and Community Center staff.
At the participant level, parent-child focus groups will be held and anonymous surveys to assess program satisfaction will be administered.
At the staff level; staff and students will be evaluated every 3 months for fidelity by the intervention coordinator through checklists and weekly logs, as well as surveys assessing the feasibility of the program.
At the community center level; they will complete brief online surveys involving policy implications, program feasibility, intervention adoption and costs, and reach of recruitment and outreach efforts.
Additionally, phone interviews will be held by study personnel to assess appropriateness and sustainability of the AFL intervention.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Noe C Crespo, MS, MPH, PhD, San Diego State University
- Principal Investigator: Daniela G Gonzalez-Valencia, PhD, Universidad Autónoma de Baja California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
September 11, 2024
First Submitted That Met QC Criteria
September 11, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
October 6, 2025
Last Update Submitted That Met QC Criteria
September 30, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2023-0308
- 1R01MD019330-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
IPD will be analyzed for the study primary and secondary outcomes.
IPD may be shared according to NIH and institutional policies.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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