Cardiovascular FitnessAFLNCT03761589
Efficacy of the Athletes for Life Program to Promote Cardiovascular Health
A study testing AFL Intervention in people with Cardiovascular Fitness and Physical Activity, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Fitness, Physical Activity
- What is being tested?
- AFL Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent ages 18 years and over
- Child ages 6-11 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Behavioral and Community Health
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Fitness, Physical Activity
- Being tested
- AFL Intervention, Wait-List Control
- Keywords
- Cardiovascular fitness, Physical Activity, Obesity, Children, Adults
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFL InterventionBehavioural
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.
Wait-List ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Wait-List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular fitness (total seconds)
Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test
Measured: 0, 12, and 24 weeks
Secondary outcomes (19)
Change in insulin concentration (uIU/mL)
Child and adult insulin concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
Measured: 0 and 12 weeks
Change in glucose concentration (mg/dL)
Child and adult glucose concentrations (plasma values) were measured via lipid panels and analyzed using Cobas automated analyzer.
Measured: 0 and 12 weeks
Change in triglyceride concentrations (mg/dL)
Child and adult triglyceride concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.
Measured: 0 and 12 weeks
Change in total low-density lipoprotein (LDL) (mg/dL)
Child and adult LDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
Measured: 0 and 12 weeks
Change in total high-density lipoprotein (HDL) (mg/dL)
Child and adult HDL cholesterol values were measured via lipid panels and analyzed using Cobas automated analyzer.
Measured: 0 and 12 weeks
Change in average systolic blood pressure (mmHg)
Child and adult systolic blood pressure was measured by an automated pressure cuff.
Measured: 0, 12, and 24 weeks
Change in average diastolic blood pressure (mmHg)
Child and adult diastolic blood pressure was measured by an automated pressure cuff.
Measured: 0, 12, and 24 weeks
Change in total percent body fat (%)
Child and adult percent body fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
Measured: 0, 12, and 24 weeks
Change in total abdominal fat mass (g)
Child and adult abdominal fat mass was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
Measured: 0, 12, and 24 weeks
Change in total trunk percent fat (%)
Child and adult trunk percent fat was measured via whole body Dual-energy X-ray absorptiometry (DXA) to assess body composition.
Measured: 0, 12, and 24 weeks
Change in waist circumference (inches)
Child and adult waist circumference was measured via a tape measure.
Measured: 0, 12, and 24 weeks
Change in Body Mass Index (BMI) (kg/m^2)
Child and adult BMI values were calculated using multiple measurements of height (cm) and weight (kg).
Measured: 0, 12, and 24 weeks
Frequency of fruit and vegetable consumption (times per month)
Child consumption of fruit and vegetables within the past month was measured via parental report using a Food Frequency Questionnaire (FFQ).
Measured: 0 and 12 weeks
Frequency of dairy food consumption (times per month)
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).
Measured: 0 and 12 weeks
Frequency of protein consumption (times per month)
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).
Measured: 0 and 12 weeks
Frequency of drink consumption (times per month)
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).
Measured: 0 and 12 weeks
Frequency of fat and sugar consumption (times per month)
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).
Measured: 0 and 12 weeks
Frequency of grain consumption (times per month)
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).
Measured: 0 and 12 weeks
Change in physical activity (minutes per day of MVPA)
Child and adult 7-day physical activity (i.e., sedentary, moderate/vigorous activity) was measured using GENEActiv accelerometers.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Jul 2016
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular FitnessStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Noe Crespo, San Diego State University
- Investigators
- Noe C Crespo, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761589
- Sponsor's protocol ID
- 14SDG20490382
- Acronym
- AFL
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vega-Lopez S, Liedike B, Todd M, Ghan E, Crespo NC, Bruening M, Hartmann L, Lorenzo Quintero A, Ray F. Effects of a Family- and Community-Based Diet and Physical Activity Intervention on Home Availability of Fruit, Vegetables, and Sugar-Containing Foods in Primarily Hispanic Households: Secondary Data Analysis from a Randomized Controlled Trial. J Nutr. 2026 Jul 10;156(9):101715. doi: 10.1016/j.tjnut.2026.101715. Online ahead of print.
PubMed 42431405Szeszulski 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.
PubMed 32061969
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Academic Partnership to Promote Cardiovascular Health Among Underserved Children and Families
- ClinicalTrials.gov ID
- NCT03761589
- Acronym / sponsor ID
- AFL / 14SDG20490382
- Conditions
- Cardiovascular Fitness, Physical Activity
- Keywords
- Cardiovascular fitness, Physical Activity, Obesity, Children, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AFL Intervention Group | Experimental | Behavioral: AFL InterventionThe 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. |
| Wait-List Control Group | Other | Behavioral: Wait-List ControlThe wait-list control group received the 12-week AFL intervention after all follow-up data had been completed. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parent ages 18 years and over
- Child ages 6-11 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFL InterventionThe 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. | Behavioural | AFL Intervention Group |
| Wait-List ControlFamilies 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. | Behavioural | Wait-List Control Group |
Primary outcome
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
19 secondary outcomes
Change in insulin concentration (uIU/mL)
Time frame: 0 and 12 weeks
Change in glucose concentration (mg/dL)
Time frame: 0 and 12 weeks
Change in triglyceride concentrations (mg/dL)
Time frame: 0 and 12 weeks
Change in total low-density lipoprotein (LDL) (mg/dL)
Time frame: 0 and 12 weeks
Change in total high-density lipoprotein (HDL) (mg/dL)
Time frame: 0 and 12 weeks
Change in average systolic blood pressure (mmHg)
Time frame: 0, 12, and 24 weeks
Change in average diastolic blood pressure (mmHg)
Time frame: 0, 12, and 24 weeks
Change in total percent body fat (%)
Time frame: 0, 12, and 24 weeks
Change in total abdominal fat mass (g)
Time frame: 0, 12, and 24 weeks
Change in total trunk percent fat (%)
Time frame: 0, 12, and 24 weeks
Change in waist circumference (inches)
Time frame: 0, 12, and 24 weeks
Change in Body Mass Index (BMI) (kg/m^2)
Time frame: 0, 12, and 24 weeks
Frequency of fruit and vegetable consumption (times per month)
Time frame: 0 and 12 weeks
Frequency of dairy food consumption (times per month)
Time frame: 0 and 12 weeks
Frequency of protein consumption (times per month)
Time frame: 0 and 12 weeks
Frequency of drink consumption (times per month)
Time frame: 0 and 12 weeks
Frequency of fat and sugar consumption (times per month)
Time frame: 0 and 12 weeks
Frequency of grain consumption (times per month)
Time frame: 0 and 12 weeks
Change in physical activity (minutes per day of MVPA)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 42431405Vega-Lopez S, Liedike B, Todd M, Ghan E, Crespo NC, Bruening M, Hartmann L, Lorenzo Quintero A, Ray F. Effects of a Family- and Community-Based Diet and Physical Activity Intervention on Home Availability of Fruit, Vegetables, and Sugar-Containing Foods in Primarily Hispanic Households: Secondary Data Analysis from a Randomized Controlled Trial. J Nutr. 2026 Jul 10;156(9):101715. doi: 10.1016/j.tjnut.2026.101715. Online ahead of print.
- Derived from this study: PubMed 32061969Szeszulski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noe C Crespo, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFL Intervention in people with Cardiovascular Fitness and Physical Activity, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular fitness (total seconds) (time frame: 0, 12, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.