CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in measure of Health-related quality of life from baseline to 6-months follow up.
研究概览
简要总结
The eCMP Pilot aims to study the feasibility and potential effectiveness of an electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.
详细描述
The eCMP is an evidence-based lifestyle intervention using a holistic, mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using existing web and mobile technologies. In this pragmatic randomized controlled trial, participants will be recruited from primary care patients of an integrated ambulatory care system. They will be randomly assigned to receive the eCMP upon completion of baseline data collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose), health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP engagement and adherence (e.g., attendance and self-monitoring).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults aged 18+ years
- •High-risk primary prevention: BMI 35+ and prediabetes (including hx of gestational diabetes) and/or metabolic syndrome
- •Secondary prevention: BMI 30+ and type 2 diabetes and/or cardiovascular disease
- •Able and willing to provide written informed consent
排除标准
- •Medical determination that the study is inappropriate or unsafe for the patient
- •Type 1 diabetes
- •Safety concerns related to significant physical or mental health issues or life expectancy of less than 12 months
- •Currently pregnant or lactating
- •No regular telephone or broadband Internet access or otherwise unable to participate in the intervention
研究组 & 干预措施
Delayed Intervention
Usual care for first three months. Initiation of the eCMP after the 3-month time point.
干预措施: eCMP (Behavioral)
Immediate Intervention
Initiation of the eCMP immediately upon completion of baseline data collection and randomization
干预措施: eCMP (Behavioral)
结局指标
主要结局
Change in measure of Health-related quality of life from baseline to 6-months follow up.
时间窗: 6-months
SF-8 questionnaire
次要结局
- Change in composite measure of Metabolic Syndrome(6-months.)
- Dietary Intake(Baseline, 3-months, and 6-months.)
- Intervention adherence(3-months and 6-months.)
- Body weight(Baseline, 3 months, and 6 months)
- Physical Activity(Baseline, 3-months, and 6-months.)