POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability (POWERSforID)
2018年11月13日 更新者：James Rimmer、University of Alabama at Birmingham
POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a telehealth and coaching intervention for improving health outcomes of adults with intellectual disability.
Recruitment is conducted through a disability health clinic located in Colorado Springs, CO.
研究概览
详细说明
POWERS (Personalized Online Weight and Exercise Response System) platform is a novel, multifocal-centered tailored intervention utilizing an innovative online tool designed to facilitate improvements in physical activity and nutritional behaviors.
Aim 1 of this protocol is to customize the POWERS platform, demonstrated effective in previous research, for adults with intellectual disability (ID) and their caregivers to be referred to as POWERSforID.
The POWERSforID intervention is designed to achieve weight loss and improve specific health markers while respecting and supporting the needs of the participants with ID as well as their caregivers.
Aim 2 of the project is to conduct a pilot study to assess the usability and feasibility of the POWERSforID system and intervention with 5 adults with ID and their caregiver and improve the system based on pilot data.
Aim 3 of the protocol is to conduct a randomized controlled trial (RCT) to examine the effect of POWERSforID on educating and coaching caregivers about nutrition and exercise and thus improving health status and reducing body weight in obese adults with ID.
The investigators hypothesize that the obese participants in the intervention group (POWERSforID) will evidence significantly greater weight loss and improved health status (i.e.
lower waist circumference, blood pressure, decreased body fat percentage, and improved blood lipids) compared to a control group.
The investigators also hypothesize that both adults with ID and their caregivers will demonstrate improved knowledge, attitudes, and self-efficacy related to diet and exercise.
研究类型
介入性
注册 (实际的)
36
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
-
-
Alabama
-
Birmingham、Alabama、美国、35292
- University of Alabama at Birmingham
-
-
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
25年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Participants with intellectual disability (ID) who meet the following inclusion criteria are eligible to participate in the study:
- Body Mass Index > or equal to 30 kg/m2;
- Diagnosis of mild or moderate ID;
- 25 to 50 years of age;
- Medical provider approval to participate in a weight loss program;
- Has a caregiver who agrees to participate in the study and provides services 4 days a week or more to the adult with ID;
- Has access to a computer with internet throughout the week.
Exclusion Criteria:
- Currently on a weight loss program;
- Medical conditions that prevent participation as noted by the medical provider or legal guardian including heart and/or renal disease;
- Behavioral issues determined by the DDHC Behavioral Health staff;
- Unable to walk or exercise due to a mobility impairment or medical condition;
- Judged to have insufficient capacity to consent or assent as assessed using the "Supplemental Consent Document".
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：卫生服务研究
- 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：POWERSforID
POWERSforID intervention group
|
Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks
|
|
无干预：Control
Usual clinical care
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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 |
|---|---|---|
|
Participation in weekly phone calls
大体时间：24 weeks
|
Number of weekly intervention phone calls attended or missed
|
24 weeks
|
|
Number of logins to the POWERSforID website
大体时间：24 weeks
|
Number of times the POWERSforID website is accessed to journal health related behaviors
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight loss
大体时间：24 weeks
|
Weight change measured in kilograms
|
24 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity questionnaire
大体时间：24 weeks
|
The questionnaire includes assessment of perceived barriers to physical activity and physical activity participation.
|
24 weeks
|
|
Mood/Psychosocial questionnaire
大体时间：24 weeks
|
Measured by the Glasgow depression scale, Psychosocial questionnaire for individuals with ID, scale for perceived physical and nutrition related barriers
|
24 weeks
|
|
Dietary recall questionnaire
大体时间：24 weeks
|
The questionnaire includes assessment of type of foods consumed.
|
24 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：James Rimmer, PhD、University of Alabama at Birmingham
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。
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 (实际的)
2016年9月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2018年10月1日
研究注册日期
首次提交
2017年4月22日
首先提交符合 QC 标准的
2017年5月3日
首次发布 (实际的)
2017年5月4日
研究记录更新
最后更新发布 (实际的)
2018年11月15日
上次提交的符合 QC 标准的更新
2018年11月13日
最后验证
2018年11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.