Clinical trial NCT06596902: Promoting Physical Activity and Fitness Among Underserved Latino Families Living in U.S.-Mexico Border Regions
Official title: Promoting Physical Activity and Fitness Among Underserved Latino Families Living in U.S.-Mexico Border Regions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity Prevention
Heart Disease
Keywords: Fitness
Healthy Lifestyle
Community Based
Family Program
Latino
U.S.-Mexico Border
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Baja California
name: San Diego State University
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-09-19
Enrollment: 290
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will test the efficacy and sustainability of an extended, 12-month AFL Program, plus a 12-month active sustainability phase through a two-group parallel arm, cluster randomized controlled trial (RCT) utilizing a Hybrid Type 1 design while also gathering critical information about the implementation process. Participants will be 290 dyads consisting of one parent/caregiver (18 years or older) and one child (6-11 years) from the same household concurrently attending intervention sessions. The child will be the unit of analysis. In each region, 2 of the 4 community centers will be randomized to one of two conditions: 1) a 12-month AFL program or 2) a control group where participants will have access to all recreation center programs available, with exception of the AFL program.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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)).

Primary outcomes:
measure: Child Physical Activity (PA)
timeFrame: 1 year
Secondary outcomes:
measure: Implementation
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Noe C Crespo, MS, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma de Baja California
name: Daniela G Gonzalez-Valencia, PhD
role: PRINCIPAL_INVESTIGATOR
References: