Clinical trial NCT03761589: Efficacy of the Athletes for Life Program to Promote Cardiovascular Health
Official title: Community-Academic Partnership to Promote Cardiovascular Health Among Underserved Children and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Fitness
Physical Activity
Keywords: Cardiovascular fitness
Physical Activity
Obesity
Children
Adults
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2018-12-03
Enrollment: 149
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiovascular fitness (total seconds)
timeFrame: 0, 12, and 24 weeks
Secondary outcomes:
measure: Change in insulin concentration (uIU/mL)
timeFrame: 0 and 12 weeks
measure: Change in glucose concentration (mg/dL)
timeFrame: 0 and 12 weeks
measure: Change in triglyceride concentrations (mg/dL)
timeFrame: 0 and 12 weeks
measure: Change in total low-density lipoprotein (LDL) (mg/dL)
timeFrame: 0 and 12 weeks
measure: Change in total high-density lipoprotein (HDL) (mg/dL)
timeFrame: 0 and 12 weeks
measure: Change in average systolic blood pressure (mmHg)
timeFrame: 0, 12, and 24 weeks
measure: Change in average diastolic blood pressure (mmHg)
timeFrame: 0, 12, and 24 weeks
measure: Change in total percent body fat (%)
timeFrame: 0, 12, and 24 weeks
measure: Change in total abdominal fat mass (g)
timeFrame: 0, 12, and 24 weeks
measure: Change in total trunk percent fat (%)
timeFrame: 0, 12, and 24 weeks
measure: Change in waist circumference (inches)
timeFrame: 0, 12, and 24 weeks
measure: Change in Body Mass Index (BMI) (kg/m^2)
timeFrame: 0, 12, and 24 weeks
measure: Frequency of fruit and vegetable consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Frequency of dairy food consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Frequency of protein consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Frequency of drink consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Frequency of fat and sugar consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Frequency of grain consumption (times per month)
timeFrame: 0 and 12 weeks
measure: Change in physical activity (minutes per day of MVPA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Institute for Behavioral and Community Health
state: California
Study officials:
affiliation: San Diego State University
name: Noe C Crespo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.