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临床试验/NCT01351649
NCT01351649已完成1 期

Middle School Physical Activity Intervention for Girls

Michigan State University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Minutes of moderate to vigorous physical activity

研究概览

简要总结

Specific aims are:

  1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2) adherence to protocols; and (3) user and provider (nurse and PA Club instructors) satisfaction.
  2. Explore if participants in the intervention group, compared to those in the control group, show improvement in the primary outcome of minutes of moderate to vigorous physical activity (MVPA; measured by accelerometer), and also secondary outcomes of self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and waist circumference at 6 months.
  3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA, perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective (enjoyment of PA) variables.
  4. Explore if participants in the intervention group, compared to those in the control group, have greater minutes of MVPA at 7 months.

详细描述

The purpose of this study is to test the feasibility of and obtain preliminary evidence of efficacy for a 6-month "Girls on the Move" intervention (guided by the Health Promotion Model and Social Cognitive Theory). The intervention involves motivational, individually tailored counseling plus after-school physical activity (PA) to increase moderate to vigorous physical activity (MVPA) and cardiovascular (CV) fitness, as well as improve body composition and cognition and affective responses related to MVPA among 6th-grade girls. Specifically, it consists of a 90-minute after-school PA Club that includes MVPA and 6 one-on-one monthly motivational, individually tailored counseling sessions with a registered (school) nurse during the school day to support each girl's continued MVPA. Applying the motivational interviewing communication style, the school nurse will individually tailor the counseling based upon each girl's key responses gleaned from computerized questionnaires assessing cognitive and affective variables related to MVPA. One middle school will be randomly assigned to receive the intervention and another to serve as attention control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
Female
接受健康志愿者
是

入选标准

  • •(1) 6th-grade girls (ages 10-12) (7th-graders if needed; up to and including age 14) who report not meeting national MVPA recommendations; (2) available and willing to participate 6 mos.; and (3) able to read, understand, and speak English (e.g., school nurse checks that girl is reading at grade level or enrolled in remedial course).

排除标准

  • •(1) Involved in school or community sports or other organized PAs or lessons, such as dance, martial arts, gymnastics, or tennis, that involve MVPA and require participation 3 or more days/wk. during every season of the school year; and (2) a health condition limiting or precluding safe MVPA.

研究组 & 干预措施

attention control

Other

Sessions with school nurse to discuss health-promoting topics and after-school health-promoting workshop. Physical activity and healthy eating were not addressed.

干预措施: middle school physical activity intervention for girls (Behavioral)

physical activity

Experimental

干预措施: middle school physical activity intervention for girls (Behavioral)

结局指标

主要结局

Minutes of moderate to vigorous physical activity

时间窗: baseline and 6 months

次要结局

  • percent body fat(baseline and 6 months)
  • waist circumference(baseline and 6 months)
  • cardiovascular fitness(baseline and 6 months)
  • Body mass index (BMI)(baseline and 6 months)
  • self-report of moderate to vigorous physical activity(baseline and 6 months)

研究者

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

Lorraine Robbins

Associate Professor

Michigan State University

研究点 (1)

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