Shared Medical Appointments for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percentage of participants from each group who lost at least 5% of their initial body weight
研究概览
简要总结
Randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.
详细描述
Obese patients will be randomized to either the control or intervention group. The intervention group will participate in 90-minute group visits occurring weekly for 4 weeks, then biweekly for a total of 26 weeks/15 visits. Each visit will focus on intensive lifestyle changes: calorie restriction to produce a 500-750 calorie deficit, increased physical activity, and behavioral therapies including regular self-monitoring of food intake, physical activity, and weight. Additional behavioral therapies that will be offered include techniques for reducing stress, maximizing sleep, and controlling environments. Further, these patients will each have the opportunity to meet one-on-one with a member of the research team at the end of each visit in order to discuss individual goals and progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patients of the USF Family or General Internal Medicine Clinics
- •BMI of 30 or greater
- •Able to speak and read English
排除标准
- •Age over 75 years, patients with end-stage renal disease with estimated GFR less than 15 mL/min, diabetes mellitus with an A1C > 9%, Acute Coronary Syndrome (such as unstable angina, pacemaker or defibrillator due to impedance scale), recent history of weight loss (>5% of body weight), pregnant or breastfeeding women, dementia or unstable psychiatric disorder, participation in any structured weight loss program currently or in the previous 3 months, cancer, or anyone unable to complete study protocol (exercise amounts, food intake).
结局指标
主要结局
Percentage of participants from each group who lost at least 5% of their initial body weight
时间窗: 6 months
Body weight will be measured at the initial and final visits using the Tanita DC-430 body composition analyzer for participants in both groups and documented in the medical record. Percent of body weight lost will be calculated for each participant and the percentage of participants who lose 5% of body weight will be included in the primary outcome.
次要结局
- Effect of visit adherence on each outcome(6 months)
- Mean change in body weight from each group from baseline to the final visit(6 months)
- Mean percent weight change of each group from baseline to the final visit(6 months)
- Mean change in doses or number of medications for hypertension or diabetes(6 months)
- Mean change in body fat percentage of each group from baseline to final visit(6 months)
- Mean change in body mass index (BMI) of each group from baseline to the final visit(6 months)
- Mean percentage of participants from each group without weight gain(6 months)
研究者
Rachel B. Franks
Assistant Professor
University of South Florida