POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Participation in weekly phone calls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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".
研究组 & 干预措施
POWERSforID
POWERSforID intervention group
干预措施: POWERSforID (Behavioral)
Control
Usual clinical care
结局指标
主要结局
Participation in weekly phone calls
时间窗: 24 weeks
Number of weekly intervention phone calls attended or missed
Number of logins to the POWERSforID website
时间窗: 24 weeks
Number of times the POWERSforID website is accessed to journal health related behaviors
次要结局
- Weight loss(24 weeks)
研究者
James Rimmer
Principal Investigator
University of Alabama at Birmingham