NCT03761589

Brief Summary

The purpose of this study was to test the efficacy of a fitness- and behavioral-focused intervention, Athletes for Life (AFL), to improve cardiorespiratory fitness (CRF) among 160 underserved families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
Last Updated

April 13, 2025

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

November 28, 2018

Last Update Submit

April 9, 2025

Conditions

Keywords

Cardiovascular fitnessPhysical ActivityObesityChildrenAdults

Outcome Measures

Primary Outcomes (1)

  • Change in cardiovascular fitness (total seconds)

    Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test

    0, 12, and 24 weeks

Secondary Outcomes (19)

  • Change in insulin concentration (uIU/mL)

    0 and 12 weeks

  • Change in glucose concentration (mg/dL)

    0 and 12 weeks

  • Change in triglyceride concentrations (mg/dL)

    0 and 12 weeks

  • Change in total low-density lipoprotein (LDL) (mg/dL)

    0 and 12 weeks

  • Change in total high-density lipoprotein (HDL) (mg/dL)

    0 and 12 weeks

  • +14 more secondary outcomes

Study Arms (2)

AFL Intervention Group

EXPERIMENTAL

The AFL intervention consisted of twice a week physical activity and nutrition sessions for children and twice a week educational and physical activity sessions for parents. Each session lasted 90 minutes and all sessions were conducted in a municipal recreation center. The child program was delivered in English while the parent program was delivered in separate English-only or Spanish-only classes.

Behavioral: AFL Intervention

Wait-List Control Group

OTHER

The wait-list control group received the 12-week AFL intervention after all follow-up data had been completed.

Behavioral: Wait-List Control

Interventions

The AFL intervention consisted of two 90-minute sessions per week for 12 months for both children and parents. The child physical activity sessions, held separately from the parent sessions, aimed to achieve 60 minutes of moderate-to-vigorous physical activity during each session through structured play activities, athletic drills, and sport exercises. Child dietary behaviors were taught through educational activities in small groups. For the parent program, behavior modification techniques were used to guide parents toward changing their own and their child's behavior. Take-home materials for self-monitoring of behaviors were used for both the child and the parent in order to reinforce concepts discussed in class.

AFL Intervention Group

Families that were randomly assigned to the wait-list control group were asked not to change their normal physical activity or dietary behaviors for the duration of the 12-week waiting period. They were asked to participate in the baseline and 12-week evaluations and then they were enrolled to receive the 12-week intervention.

Wait-List Control Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parent ages 18 years and over
  • Child ages 6-11 years

You may not qualify if:

  • Presence of a mental or physical condition that was contraindicated to participating in sports/exercise
  • Having a chronic condition that limited mobility
  • Taking medications that influenced body composition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Behavioral and Community Health

San Diego, California, 92123, United States

Location

Related Publications (1)

  • Szeszulski J, Vega-Lopez S, Todd M, Ray F, Behar A, Campbell M, Chavez A, Eckert R, Lorenzo-Quintero A, Hartmann Manrique L, Crespo NC. Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families. Contemp Clin Trials. 2020 Apr;91:105956. doi: 10.1016/j.cct.2020.105956. Epub 2020 Feb 13.

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noe C Crespo, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Families (i.e., children and parents/primary caregivers dyads) were randomly assigned to participate in either the intervention group or a wait-list control group. The intervention (AFL) consisted of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center. The wait-list control group received the intervention after all follow-up data had been collected. Data from all participants (both intervention group and wait-list group) were collected in four phases: before the intervention group started the program (week 0) and at 6, 12, and 24 weeks, thereafter.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2018

First Posted

December 3, 2018

Study Start

July 1, 2016

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

April 13, 2025

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations