- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761589
Efficacy of the Athletes for Life Program to Promote Cardiovascular Health (AFL)
April 9, 2025 updated by: Noe Crespo, San Diego State University
Community-Academic Partnership to Promote Cardiovascular Health Among Underserved Children and Families
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Athletes for Life (AFL) study was a 12-week randomized controlled trial designed to promote cardiorespiratory fitness (CRF) and healthy lifestyle changes among parents and children.
The original enrollment target was 160 families.
A total of 149 parent-child dyads living in a Southwestern U.S. metropolitan area were enrolled in the study.
AFL consisting of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center.
Behavior change, including increased physical activity, and adherence were motivated through positive reinforcement techniques.
Families were randomized to either the AFL program or a wait-list control group.
Study Type
Interventional
Enrollment (Actual)
149
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 Locations
-
-
California
-
San Diego, California, United States, 92123
- Institute for Behavioral and Community Health
-
-
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
6 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Parent ages 18 years and over
- Child ages 6-11 years
Exclusion Criteria:
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AFL Intervention Group
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.
|
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.
|
|
Other: Wait-List Control Group
The wait-list control group received the 12-week AFL intervention after all follow-up data had been completed.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cardiovascular fitness (total seconds)
Time Frame: 0, 12, and 24 weeks
|
Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test
|
0, 12, and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in insulin concentration (uIU/mL)
Time Frame: 0 and 12 weeks
|
Child and adult insulin concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
|
0 and 12 weeks
|
|
Change in glucose concentration (mg/dL)
Time Frame: 0 and 12 weeks
|
Child and adult glucose concentrations (plasma values) were measured via lipid panels and analyzed using Cobas automated analyzer.
|
0 and 12 weeks
|
|
Change in triglyceride concentrations (mg/dL)
Time Frame: 0 and 12 weeks
|
Child and adult triglyceride concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
|
0 and 12 weeks
|
|
Change in total low-density lipoprotein (LDL) (mg/dL)
Time Frame: 0 and 12 weeks
|
Child and adult LDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
|
0 and 12 weeks
|
|
Change in total high-density lipoprotein (HDL) (mg/dL)
Time Frame: 0 and 12 weeks
|
Child and adult HDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
|
0 and 12 weeks
|
|
Change in average systolic blood pressure (mmHg)
Time Frame: 0, 12, and 24 weeks
|
Child and adult systolic blood pressure was measured by an automated pressure cuff.
|
0, 12, and 24 weeks
|
|
Change in average diastolic blood pressure (mmHg)
Time Frame: 0, 12, and 24 weeks
|
Child and adult diastolic blood pressure was measured by an automated pressure cuff.
|
0, 12, and 24 weeks
|
|
Change in total percent body fat (%)
Time Frame: 0, 12, and 24 weeks
|
Child and adult percent body fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
|
0, 12, and 24 weeks
|
|
Change in total abdominal fat mass (g)
Time Frame: 0, 12, and 24 weeks
|
Child and adult abdominal fat mass was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
|
0, 12, and 24 weeks
|
|
Change in total trunk percent fat (%)
Time Frame: 0, 12, and 24 weeks
|
Child and adult trunk percent fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
|
0, 12, and 24 weeks
|
|
Change in waist circumference (inches)
Time Frame: 0, 12, and 24 weeks
|
Child and adult waist circumference was measured via a tape measure.
|
0, 12, and 24 weeks
|
|
Change in Body Mass Index (BMI) (kg/m^2)
Time Frame: 0, 12, and 24 weeks
|
Child and adult BMI values were calculated using multiple measurements of height (cm) and weight (kg).
|
0, 12, and 24 weeks
|
|
Frequency of fruit and vegetable consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child consumption of fruit and vegetables within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Frequency of dairy food consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child consumption of dairy foods (i.e., cheese, milk and yogurt) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Frequency of protein consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child protein consumption (i.e., meat, fish, eggs and beans) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Frequency of drink consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child consumption of drinks other than milk and 100% fruit juice (i.e., water, soda, and flavored drinks) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Frequency of fat and sugar consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child consumption of fats and sugars (e.g., butter, potato chips, pastries) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Frequency of grain consumption (times per month)
Time Frame: 0 and 12 weeks
|
Child consumption of grains (e.g., cereals, brown rice, pasta) within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
|
0 and 12 weeks
|
|
Change in physical activity (minutes per day of MVPA)
Time Frame: 12 weeks
|
Child and adult 7-day physical activity (i.e., sedentary, moderate/vigorous activity) was measured using GENEActiv accelerometers.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Noe C Crespo, PhD, San Diego State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 1, 2016
Primary Completion (Actual)
March 31, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
November 29, 2018
First Posted (Actual)
December 3, 2018
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 14SDG20490382
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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