Promoting Physical Activity and Fitness Among Underserved Latino Families Living in U.S.-Mexico Border Regions

NCT06596902 | Recruiting

• 2 other identifiers: HS-2023-03081R01MD019330-01
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention; Heart Disease

Keywords

Fitness; Healthy Lifestyle; Community Based; Family Program; Latino; U.S.-Mexico Border

Outcome Measures

Primary Outcomes (1)

• Child Physical Activity (PA)

  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 Outcomes (1)

• Implementation

  1 year

Study Arms (2)

Intervention Program

EXPERIMENTAL

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.

Behavioral: Physical Activity

Control Group

NO INTERVENTION

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.

Interventions

Physical Activity BEHAVIORAL

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.

Intervention Program

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• parents aged ≥18 years
• children aged 6-11 years
• living in the target community (within 5 miles of one of targeted community centers)

You may not qualify if:

• 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)).

Sponsors & Collaborators

• San Diego State University: lead
• Universidad Autonoma de Baja California: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noe C Crespo, MS, MPH, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Daniela G Gonzalez-Valencia, PhD

  Universidad Autonoma de Baja California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noe C Crespo, MS, MPH, PhD

CONTACT

619-594-2395; ncrespo@sdsu.edu

Bianca Vargas-Tequida, MS

CONTACT

619-514-5770; bvargastequida@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)