Efficacy of the Athletes for Life Program to Promote Cardiovascular Health

Physical Activity Clinical Trial

— AFL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761589
• Other study ID #: 14SDG20490382
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2018
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Fitness
• Physical Activity

Intervention

Behavioral:
• AFL Intervention
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
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.

Locations

Country	Name	City	State
United States	Institute for Behavioral and Community Health	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in insulin concentration (uIU/mL)	Child and adult insulin concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.	0 and 12 weeks
Secondary	Change in glucose concentration (mg/dL)	Child and adult glucose concentrations (plasma values) were measured via lipid panels and analyzed using Cobas automated analyzer.	0 and 12 weeks
Secondary	Change in triglyceride concentrations (mg/dL)	Child and adult triglyceride concentrations were measured via lipid panels and analyzed using Cobas automated analyzer.	0 and 12 weeks
Secondary	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.	0 and 12 weeks
Secondary	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.	0 and 12 weeks
Secondary	Change in average systolic blood pressure (mmHg)	Child and adult systolic blood pressure was measured by an automated pressure cuff.	0, 12, and 24 weeks
Secondary	Change in average diastolic blood pressure (mmHg)	Child and adult diastolic blood pressure was measured by an automated pressure cuff.	0, 12, and 24 weeks
Secondary	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.	0, 12, and 24 weeks
Secondary	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.	0, 12, and 24 weeks
Secondary	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.	0, 12, and 24 weeks
Secondary	Change in waist circumference (inches)	Child and adult waist circumference was measured via a tape measure.	0, 12, and 24 weeks
Secondary	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).	0, 12, and 24 weeks
Secondary	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).	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	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.	12 weeks