Wellness Engagement Project, Petersburg (WE)
2016年1月8日 更新者:Virginia Commonwealth University
This study tests the feasibility of a health and wellness trial designed with community input.
This 12-week program will be tested over a 24-week period using a delayed treatment control group.
研究概览
详细说明
This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period.
The 12 week program is designed to impact three levels: individual, family and community.
At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals.
At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members.
On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Virginia
-
Richmond、Virginia、美国、23298
- Virginia Commonwealth University
-
-
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
12年 至 65年 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 18-65 years.
- Must have a school going child between 12-17 living in the home.
- BMI between 25 and 50 kg/m2.
Exclusion Criteria:
- report not being able to walk 2 blocks (1/4 mile) without stopping
- currently participating in another weight loss program
- taking a weight loss medication
- have a history of bariatric surgery
- pregnant or plan to become pregnant during the intervention timeframe
- report an unsupervised heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines (e.g., uncontrolled heart problem)
- fail medical screening by study medical staff)
- report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., planned move from the area, dementia, substance abuse).
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 |
|---|---|
|
实验性的:Intervention-Wellness Engagement Program
The group assigned to the intervention arm will receive treatment as described below for a twelve week period: Weekly lessons related to healthy eating and physical activity Biweekly check-in calls with a trained peer support coach Access to neighborhood wide physical activity and nutritional education events |
This intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants.
The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes.
|
|
无干预:Delayed treatment control group
The delayed treatment control group will not receive the intervention for measurement purposes; however the intervention as described will be administered to this group upon conclusion of the 12 week period for the intervention group.
|
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 |
|---|---|---|
|
Engagement in WE activities
大体时间:4-weeks
|
Number of community events attended
|
4-weeks
|
|
Video lessons
大体时间:4 weeks
|
Number of video lessons viewed as reported to Wellness Ambassadors
|
4 weeks
|
|
Peer Support
大体时间:4 weeks
|
number of check-in phone calls completed with Peer Support Coaches
|
4 weeks
|
|
Self-monitoring logs
大体时间:4 weeks
|
number of self-monitoring logs completed
|
4 weeks
|
|
Value of the program
大体时间:4 weeks
|
Perceived value of the program
|
4 weeks
|
|
Effectiveness of peer support
大体时间:4 weeks
|
Perception of the effectiveness of the peer support received from peer coaches
|
4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Uptake of key behaviors promoted in the WE program
大体时间:4-weeks
|
Engagement in recommended health behaviors
|
4-weeks
|
|
Weight
大体时间:4-weeks
|
Weight will be measured in kg
|
4-weeks
|
|
Dietary changes
大体时间:4-weeks
|
Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)
|
4-weeks
|
|
Height
大体时间:4 weeks
|
height measured in meters
|
4 weeks
|
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:Maghboeba Mosavel, PhD、Virginia Commonwealth University
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
2015年3月1日
初级完成 (实际的)
2015年8月1日
研究完成 (实际的)
2015年8月1日
研究注册日期
首次提交
2015年6月5日
首先提交符合 QC 标准的
2016年1月8日
首次发布 (估计)
2016年1月12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
与本研究相关的术语
其他研究编号
- 5R24MD008128 (美国 NIH 拨款/合同)
- 1R24MD008128 (美国 NIH 拨款/合同)
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.