Starting Healthy Staying Healthy Pilot Trial
研究概览
详细说明
TV viewing is among the most significant features of childhood. In the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of TV, one-third under 6 have TVs in their bedrooms, and 30% make TV part of bedtime routines. By the age of 2 years, 90% of children watch TV or videos regularly. Among those who watch, average viewing is 1.5 hours daily by age 2.
Yet the effects of this early viewing are poorly understood. In this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods.
We will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). A case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. In addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. The website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. The control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. At the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch TV compared to control-arm infants.
The comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Washington
-
Seattle、Washington、美国、98195
- Child Health Institute, University of Washington
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Must watch at least 1.5 hours of television a day on average
- Must speak English at home
- Residence in or near Seattle
Exclusion Criteria:
- Developmental delay
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Parents receive tailored health-behavior change messages designed to reduce their child's exposure to televised food commercials.
Intervention is delivered by a case manager, by a website, and by periodic newsletters.
|
Parents receive a health behavior-change intervention consisting of 1 in-person visit from a case manager, followed by phone and e-mail contact at least monthly.
The intervention is designed to promote healthy TV viewing, including viewing fewer commercials, by the target child aged 2-5 years old, and uses health behavior change theory and social cognitive theory.
|
有源比较器:Control
Parents of children ages 2-5 receive behavioral-change counseling around toddler & preschooler safety and injury prevention.
|
Parents receive behavior-change counseling around toddler and preschooler safety and injury prevention.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Consumption of foods frequently advertised on television (sugary cereals, sugary beverages, candy, fast food, salty snacks)
大体时间:at conclusion of trial and 6 months post-intervention
|
at conclusion of trial and 6 months post-intervention
|
合作者和调查者
调查人员
- 首席研究员:Frederick J Zimmerman, Ph.D.、University of Washington
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 07-6609-J01
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
TV modification的临床试验
-
Teva Branded Pharmaceutical Products R&D, Inc.完全的多发性硬化症美国, 奥地利, 保加利亚, 加拿大, 捷克语, 爱沙尼亚, 法国, 乔治亚州, 德国, 匈牙利, 以色列, 意大利, 立陶宛, 荷兰, 波兰, 罗马尼亚, 俄罗斯联邦, 塞尔维亚, 西班牙, 瑞典, 火鸡, 乌克兰, 英国, 拉脱维亚
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘艾滋病病毒 | 性传播感染(不是 HIV 或肝炎)
-
Teva Branded Pharmaceutical Products R&D, Inc.FHI 360完全的
-
Teva Branded Pharmaceutical Products R&D, Inc.主动,不招人精神分裂症美国, 保加利亚, 中国, 罗马尼亚, 火鸡
-
Teva Branded Pharmaceutical Products R&D, Inc.完全的
-
Teva Pharmaceutical Industries, Ltd.终止
-
Wits RHI Research Centre Clinical Research SiteUniversity of Alabama at Birmingham; University of California, San Francisco招聘中
-
Teva Branded Pharmaceutical Products R&D, Inc.完全的原发性进行性多发性硬化症美国, 加拿大, 德国, 意大利, 荷兰, 波兰, 俄罗斯联邦, 西班牙, 乌克兰, 英国