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临床试验/NCT00186173
NCT00186173已完成1 期

Sports to Prevent Obesity: Feasibility and Pilot RCT

Stanford University0 个研究点目标入组 21 人开始时间: 2004年11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
21
主要终点
Body mass index

研究概览

简要总结

The purpose of this study is to learn whether overweight children who participate in an after school sports program improve their health as much as overweight children in a more traditional health education program.

详细描述

After school sports programs may be generalizable, motivating and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included.

We propose a two-phase project in East Palo Alto, California, a low-income, primarily Latino, African-American and Pacific Islander community. The first phase will be a 3-month feasibility trial of an after school team sports program for overweight children to examine several theory-driven approaches to program design and implementation, including assessments of liking and participation and barriers and facilitators of participation. The second phase will be a 6-month randomized controlled pilot trial (RCT) comparing weight changes among overweight children randomized to participate in the after school team sports program versus a traditional weight control/health education program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • In 4th or 5th grade of a participating school at time of enrollment
  • BMI greater than or equal to the 85th percentile on the 2000 CDC growth charts
  • Medical clearance obtained from primary care provider

排除标准

  • Our goal is to be inclusive as possible, however, children will not be eligible to participate if they:
  • have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease)
  • are pregnant
  • have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
  • have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
  • are taking other medications potentially affecting their growth and/or weight (e.g. methylphenidate HCL)
  • are unable to complete the informed consent process

研究组 & 干预措施

After school sports

Experimental

After school team sports intervention designed specifically for overweight and obese children

干预措施: After school sports program (Behavioral)

After school health education

Active Comparator

After school heath and nutrition education program

干预措施: After school health education (Behavioral)

结局指标

主要结局

Body mass index

时间窗: Baseline, 3 and 6 months

次要结局

  • Psychosocial measures(baseline, 3 and 6 months)
  • Triceps skinfold thickness(baseline, 3 and 6 months)
  • Waist circumference(Baseline, 3 and 6 months)
  • Physical activity monitoring(baseline, 3 and 6 months)
  • Resting heart rate(baseline, 3 and 6 months)
  • Sedentary behaviors(baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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