NCT04433806已完成不适用
The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Participants enrolled
研究概览
简要总结
The purposes of this study is to evaluate the feasibility of providing a community based referral to Mayo Clinic Employee and Community Health patients for weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are between 18-65 years of age
- •Patients who have a BMI between 25-39.9 kg/m2
- •Ability to provide informed consent
- •Ability to complete the Diabetes Prevention Program including dietary and physical activity recommendations
- •Motivated to lose weight (assessed to be in the preparation or action stage)
排除标准
- •Have used weight loss medications or participated in a weight loss program within the past 30 days.
- •Are currently enrolled in DPP or other ExercisAbilities weight loss programs
- •Are currently taking supplements known to affect weight.
- •Have had weight fluctuations of 20 pounds or more in the past 6 months (EMR check and self-report)
- •Have an active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)
- •Are currently pregnant or breastfeeding, or are of child-bearing potential and are likely to become pregnant during the study (within the next 4 months following enrollment)
- •Have a history in the past 4 months of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease
- •Have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions
- •Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) or active cancer or are within 1 year of cancer remission
- •Have a known history of any condition or factor judged by the investigator/study team to preclude participation in the study or which might hinder adherence
- •Have any co-morbidity that is deemed exclusionary at the discretion of the provider.
结局指标
主要结局
Participants enrolled
时间窗: Through study completion, approximately 28 weeks
Total number of participants enrolled
Participants recruited
时间窗: Through study completion, approximately 28 weeks
Total number of participants recruited
Participants accrued
时间窗: Through study completion, approximately 28 weeks
Total number of participants accrued
Participants to withdrawn or terminate study participation
时间窗: Through study completion, approximately 28 weeks
Total number of participants to withdrawn or terminate study participation
次要结局
- Change in Body Mass Index (BMI)(Baseline, week 16, week 28)
- Participant satisfaction(At study completion, approximately 28 weeks)
- Change in weight(Baseline, week 16, week 28)
- Staff satisfaction(At study completion, approximately 28 weeks)
研究者
Tamim I. Rajjo, M.D.
Principal Investigator
Mayo Clinic
研究点 (2)
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