Healthy Homes/Healthy Families (HHHF)
2016年1月8日 更新者:Michelle C. Kegler、Emory University
The purpose of the study is to learn how to make homes more supportive of healthy eating and physical activity.
As part of the study, participants will be randomly assigned to one of two groups.
One group will receive materials with information on healthy eating and physical activity.
The materials will be mailed 3 times over a 5 month period.
The other group will work with a coach to make their homes more supportive of healthy eating and physical activity.
Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5 month period.
This group will also receive materials by mail 4 different times.
All participants will be asked to complete 7 telephone interviews over a 1 year period.
Participants will also be asked to wear an accelerometer, a small portable device that tracks movement from physical activity, for 7 days at 2 different points in the study.
研究概览
研究类型
介入性
注册 (实际的)
510
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Female
- 35-65 years old
- BMI greater than or equal to 25
- Speak English
- Must live with at least one other person
- Live within 30 miles of 1 of 9 clinics referring patients in the study
- Must have no contraindications for physical activity
- Must have no contraindications for participating in a medically unsupervised study
Exclusion Criteria:
- 1 person per household
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Comparison Group
Comparison group participants will be given health education materials.
|
Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
|
|
实验性的:Intervention'
This group will receive the intervention (Healthy Homes/Healthy Families) as described below.
|
Participants in the intervention group will work with coaches to make their homes more supportive of healthy eating and physical activity.
Each intervention participant will receive a tailored home environment profile, and will select from a "menu" of healthy actions to make changes in their home.
The intervention will be delivered over the course of 5 months, with 3 home visits, 4 coaching calls, and 4 support mailings.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diet & Physical Activity
大体时间:Baseline, 6 months, and 12 months
|
Diet and physical activity will be assessed by telephone interviews.
Physical activity will also be assessed using accelerometers at baseline and 6 months.
|
Baseline, 6 months, and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight
大体时间:Baseline, 6 months, and 12 months
|
Self-report weight will be assessed by telephone interview.
|
Baseline, 6 months, and 12 months
|
|
Changes in the home physical and social environment
大体时间:Baseline, 6 months, and 12 months
|
A home environment survey will be administered by telephone.
|
Baseline, 6 months, and 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michelle C Kegler, DrPH, MPH、Emory University, Rollins School of Public Health
- 首席研究员:Julie Gazmararian, PhD、Emory University, Rollins School of Public Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kegler MC, Haardorfer R, Alcantara IC, Gazmararian JA, Veluswamy JK, Hodge TL, Addison AR, Hotz JA. Impact of Improving Home Environments on Energy Intake and Physical Activity: A Randomized Controlled Trial. Am J Public Health. 2016 Jan;106(1):143-52. doi: 10.2105/AJPH.2015.302942.
- Haardorfer R, Alcantara IC, Patil D, Hotz J, Kegler MC. Physical activity profiles of overweight and obese women in rural Georgia. JAMA Intern Med. 2014 Jan;174(1):148-9. doi: 10.1001/jamainternmed.2013.11571. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年2月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2013年7月1日
研究注册日期
首次提交
2011年3月30日
首先提交符合 QC 标准的
2011年3月30日
首次发布 (估计)
2011年3月31日
研究记录更新
最后更新发布 (估计)
2016年1月12日
上次提交的符合 QC 标准的更新
2016年1月8日
最后验证
2016年1月1日
更多信息
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.