NCT07847645

Brief Summary

Childhood obesity affects 36.6% of children in Mexico and nearly 50% in Baja California. Traditional weight-centered interventions yield modest and unsustainable results. In contrast, improving cardiorespiratory fitness provides broad health benefits independently of weight loss. This quasi-experimental study assesses the feasibility and viability of Athletes for Life (AFL)-a community- and family-based behavioral program for parent-child dyads in Mexicali-comparing its overall impact against a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

September 17, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

FitnessPhysical ActivityFeasibility pilot studyNutritionSchoolchildrenFamilyHealthy Lifestyle Program

Outcome Measures

Primary Outcomes (4)

  • 1-Mile Run/Walk Test completition time (seconds)

    Time required to complete a 1,605-meter (1-mile) run/walk test, recorded in minutes and seconds. The test was used as an indirect measure of cardiorespiratory fitness in adults and children. Unit of measure: seconds.

    Baseline, 4.5, 9 and 12 months

  • Estimated VO₂max (mL/kg/min)

    Maximum oxygen consumption (VO₂max) estimated using the Three-Minute Step Test (TMST). Adults and children stepped onto an 11-inch platform at a constant cadence of 96 beats per minute (BPM) for 3 minutes. Heart rate was monitored using a Polar FT1 device. Unit of measure: mL/kg/min

    Baseline, 4.5, 9, and 12 months

  • Moderate-to-vigorous physical activity (MVPA) (minutes/day)

    Daily time spent in moderate-to-vigorous physical activity, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.

    Baseline, 9 and 12 months

  • Sedentary time (minutes/day)

    Daily time spent in sedentary behavior, objectively assessed in adults and children using a waist-worn ActiGraph wGT3X-BT accelerometer during 7-day assessment periods. A minimum of 4 valid days, with at least 600 minutes of wear time per day, was required for inclusion in the analysis. Unit of measure: minutes/day.

    Baseline, 9, and 12 months

Secondary Outcomes (15)

  • BMI-for-age z-score

    Baseline, 4.5, 9, and 12 months

  • Body Mass Index (BMI) (kg/m²)

    Baseline, 4.5, 9, and 12 months

  • Waist-to-height ratio

    Baseline, 4.5, 9, and 12 months

  • Waist-to-hip ratio

    Baseline, 4.5, 9, and 12 months

  • Systolic and diastolic blood pressure (mmHg)

    Baseline, 4.5, 9, and 12 months

  • +10 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The Athletes for Life (AFL) program in Mexicali is adapted from the original AFL methodology (Crespo et al., 2015) using national and international nutrition and physical activity guidelines. Program Structure * Phases: The program is divided into four progressive stages: beginner, intermediate, advanced, and a final sustainability phase. * Duration: The active phase lasts 9 months, featuring biweekly 1.5-hour sessions structured in both separate (parents/children) and joint family formats. * Sustainability: A 3-month non-intensive follow-up period promotes family autonomy through weekly phone calls or messages. * Theoretical Framework \& Strategies The curriculum integrates operant conditioning and the socioecological model to encourage healthy behavior changes across individual, interpersonal, and social levels. Key strategies include: positive reinforcement, a point/reward system, goal setting, self-monitoring, behavior modeling and social support.

Behavioral: Healthy lifestyle program

Control group

OTHER

The control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition.

Other: Control group

Interventions

The AFL program in Mexicali is a family-based healthy lifestyle behavioral program aimed at improving physical fitness, physical activity level, diet quality, and metabolic risk indicators. Structure \& Phases: Features a 9-month active phase (biweekly 1.5-hour sessions progressing through beginner, intermediate, and advanced stages) followed by a 3-month sustainability phase with weekly remote check-ins. * Behavioral Framework: Built on operant conditioning and socioecological models using goal setting, point/reward systems, positive reinforcement, and healthy food environments. * Core Components: Nutrition Education: Teaches portion sizes, food groups, and beverage choices (45 minutes for adults, 10 minutes for children). Physical Exercise: Focuses on physical conditioning, motor skills, and sports like soccer, volleyball, and baseball (45 minutes for adults, 80 minutes for children). Olympic Events: Celebratory family physical activity events held at the end of each stage.

Intervention group

The control group did not receive any AFL program content throughout the study period. Instead, participating families received monthly 90-minute health-promotion sessions consisting of educational presentations and simple activities aimed at promoting healthy lifestyle behaviors, with a focus on physical activity and nutrition.

Control group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parent or caregiver aged 18 years or older
  • Child aged 6 to 12 years
  • Residence within 4 km of one of the targeted community centers

You may not qualify if:

  • Presence of a mental or physical condition that contraindicated participation in sports/exercise
  • Participation in formal sports activities (e.g., baseball, karate, or soccer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma de Baja California

Mexicali, Estado de Baja California, Mexico

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alva Nidia Laprada Villegas, MS

    Universidad Autonoma de Baja California

    PRINCIPAL INVESTIGATOR
  • Daniela Guadalupe Gonzalez Valencia, PhD

    Universidad Autonoma de Baja California

    STUDY DIRECTOR
  • Noe C Crespo, MS, MPH, PhD

    San Diego State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study employed a quasi-experimental two-group design incorporating both quantitative and qualitative methods to assess the feasibility of the AFL program and explore factors related to effective long-term implementation (e.g., acceptability, barriers, and facilitators). The program was implemented and evaluated over a 12-month period, divided into four phases. The control group received only monthly health-promotion sessions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 29, 2026

Study Start

May 23, 2024

Primary Completion

September 29, 2025

Study Completion

October 3, 2025

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside the research team to protect participant confidentiality, as specified in the informed consent.

Locations