Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Rate of Referral
研究概览
简要总结
This is a randomized quality improvement project (i.e., not a research study) that will test the implementation and effectiveness of a lifestyle medicine clinic at the University of Alabama at Birmingham.
详细描述
This is a randomized quality improvement project that has received a non-human subjects research determination from the IRB at the University of Alabama at Birmingham. This study will use a randomized encouragement trial design to test whether a lifestyle medicine clinic at UAB (FLOW: Fitness, Lifestyle, and Optimum Wellness) is implementable and effective for improving cardiometabolic health (e.g., body weight, body composition, blood pressure, blood glucose, and blood lipids). Only patients of the UAB Family and Community Clinic are included in this project (i.e., no outside recruitment/enrollment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient of the UAB Family & Community Medicine Clinic or UAB Rheumatology Clinic
- •BMI: greater than or equal to 25 kg/m2
- •Previous diagnosis of at least one of the following conditions:
- •prediabetes or type 2 diabetes
- •prehypertension or hypertension
- •dyslipidemia
- •psoriatic arthritis
排除标准
- •Not a current patient of the UAB Family & Community Medicine Clinic or UAB Rheumatology Clinic
研究组 & 干预措施
Encouraged to Enroll in FLOW
Patients randomized to this condition receive extra encouragement to consider enrolling in the FLOW lifestyle medicine clinic. This encouragement includes the addition of 2 questions added to their patients' pre-visit intake process regarding their interest in making healthy lifestyle changes to improve their cardiometabolic health. If affirmative, the Certified Medical Assistant will provide the patient with a FLOW brochure and make a note for the provider to follow-up with the patient and consider referral to the FLOW clinic.
干预措施: FLOW Lifestyle Medicine Clinic (Behavioral)
Not Encouraged to Enroll in FLOW
Patients randomized to this condition do not receive extra encouragement to enroll in the FLOW lifestyle medicine clinic. They are still able to access to the FLOW clinic via brochures placed in the waiting area and exam rooms or direct referral by their healthcare provider (without having been "encouraged.")
干预措施: FLOW Lifestyle Medicine Clinic (Behavioral)
结局指标
主要结局
Rate of Referral
时间窗: Baseline
Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.
Rate of Enrollment
时间窗: Baseline
Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.
次要结局
- ITT Estimand, Change in Body Weight(Baseline and 12 months)
- ITT Estimand, Change in Composite Cardiometabolic Health(Baseline to Month 12)
- Complier Average Causal Effect, Change in Body Weight(Baseline and 12 months)
- Complier Average Causal Effect, Change in Composite Cardiometabolic Health(Baseline to Month 12)
研究者
Drew Sayer
Assistant Professor
University of Alabama at Birmingham