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临床试验/NCT03761589
NCT03761589已完成不适用

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

San Diego State University2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
Change in cardiovascular fitness (total seconds)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent ages 18 years and over
  • Child ages 6-11 years

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: AFL Intervention (Behavioral)

Wait-List Control Group

Other

The wait-list control group received the 12-week AFL intervention after all follow-up data had been completed.

干预措施: Wait-List Control (Behavioral)

结局指标

主要结局

Change in cardiovascular fitness (total seconds)

时间窗: 0, 12, and 24 weeks

Child and adult cardiovascular fitness was assessed using a 1-mile run/walk test

次要结局

  • Change in insulin concentration (uIU/mL)(0 and 12 weeks)
  • Change in waist circumference (inches)(0, 12, and 24 weeks)
  • Frequency of dairy food consumption (times per month)(0 and 12 weeks)
  • Change in triglyceride concentrations (mg/dL)(0 and 12 weeks)
  • Frequency of fruit and vegetable consumption (times per month)(0 and 12 weeks)
  • Change in total low-density lipoprotein (LDL) (mg/dL)(0 and 12 weeks)
  • Change in total abdominal fat mass (g)(0, 12, and 24 weeks)
  • Change in total trunk percent fat (%)(0, 12, and 24 weeks)
  • Change in Body Mass Index (BMI) (kg/m^2)(0, 12, and 24 weeks)
  • Frequency of protein consumption (times per month)(0 and 12 weeks)
  • Frequency of drink consumption (times per month)(0 and 12 weeks)
  • Frequency of fat and sugar consumption (times per month)(0 and 12 weeks)
  • Frequency of grain consumption (times per month)(0 and 12 weeks)
  • Change in physical activity (minutes per day of MVPA)(12 weeks)
  • Change in glucose concentration (mg/dL)(0 and 12 weeks)
  • Change in total high-density lipoprotein (HDL) (mg/dL)(0 and 12 weeks)
  • Change in average systolic blood pressure (mmHg)(0, 12, and 24 weeks)
  • Change in total percent body fat (%)(0, 12, and 24 weeks)
  • Change in average diastolic blood pressure (mmHg)(0, 12, and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noe Crespo

Assistant Professor

San Diego State University

研究点 (2)

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