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Completed

NCT Number: NCT03761589

Efficacy of the Athletes for Life Program to Promote Cardiovascular Health

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.

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Key information

Conditions

Cardiovascular Fitness Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Behavioral and Community Health

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFL Intervention

Behavioral

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 control

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Change in waist circumference (inches)

    Time frame: 0, 12, and 24 weeks

    Child and adult waist circumference was measured via a tape measure.

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Arizona State University

Registry information

Official study title

Community-Academic Partnership to Promote Cardiovascular Health Among Underserved Children and Families

Acronym: AFL

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2018
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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