Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Percent weight loss at 18 months
研究概览
简要总结
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months.
详细描述
Obesity increases risk for 13 types of cancer and now affects over 40% of the U.S. adult population, with even higher prevalence among rural Americans. Rural residents often lack access to weight control programs and food and physical activity resources that promote healthy lifestyles, especially in small or remote rural areas. It is important for obesity treatment to be offered in rural primary care, yet local resources are often lacking. Medical management by a primary care provider (PCP) during behavioral weight loss is essential to address co-morbid medical conditions, evaluate obesogenic medications, and explore options for guideline-recommended pharmacotherapy and surgical treatment. This study is designed to enhance sustainable access to obesity treatment in rural communities by offering education to local providers on obesity management and integrating team-based care into an obesity treatment model through telemedicine.
The two methods of obesity treatment to be studied are:
- Local Care + Arm: Quarterly clinic visits with the participants and their local primary care provider
- Team Care Arm: An intensive group lifestyle intervention offered by a lifestyle coach via Zoom, paired with quarterly clinic visits with the participant, their local primary care provider and the lifestyle coach, the coach joining via telemedicine.
Participants will be in the study about 18 months. Participants in the Local Care + arm will be asked to complete 4 data collection visits and 6 quarterly clinic visits. Participants in the Team Care arm will be asked to complete 4 data collection visits, 30 counseling sessions and 6 quarterly clinic visits.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: >= 30 kg/m2
- •Rural resident
- •English speaking
- •Physician clearance to participate
- •Able to walk without assistance
- •Seen at least once in their primary care clinic within the past year
- •Internet access or smart phone (to access smart scale for weight measurement)
排除标准
- •History of myocardial infarction within last six months
- •History of stroke within last six months
- •History of new cancer diagnosis within last six months
- •History of bariatric surgery within the last two years
- •Pregnancy within last 6 months or planned within the next 18 months
- •Currently breastfeeding
- •End stage renal disease, currently on dialysis, or anticipated dialysis or renal transplant within the next 18 months
- •End stage liver disease, or anticipated liver transplant within the next 18 months
- •Currently enrolled or planning to enroll in another study where weight loss is targeted or weight fluctuation is expected
- •Currently planning to move outside of current provider area, or leave primary care clinic within the next 18 months
- •Another household member is already participating in the study
结局指标
主要结局
Percent weight loss at 18 months
时间窗: 18 months
Mean percent weight loss at 18 months; unadjusted
次要结局
- Proportion achieving ≥10% weight loss at 18 months(18 months)
- Change in diet quality at 6 months(Baseline and 6 months)
- Percent weight loss at 6 months(6 months)
- Percent weight loss at 12 months(12 months)
- Weight loss (kg) at 6 months(6 months)
- Weight loss (kg) at 12 months(12 months)
- Weight loss (kg) at 18 months(18 months)
- Proportion achieving ≥5% weight loss at 6 months(6 months)
- Proportion achieving ≥5% weight loss at 12 months(12 months)
- Proportion achieving ≥5% weight loss at 18 months(18 months)
- Proportion achieving ≥10% weight loss at 6 months(6 months)
- Proportion achieving ≥10% weight loss at 12 months(12 months)
- Change in physical activity at 6 months(Baseline and 6 months)
- Change in physical activity at 12 months(Baseline and 12 months)
- Change in mental quality of life at 6 months(Baseline and 6 months)
- Change in diet quality at 12 months(Baseline and 12 months)
- Change in diet quality at 18 months(Baseline and 18 months)
- Change in physical activity at 18 months(Baseline and 18 months)
- Change in physical quality of life at 12 months(Baseline and 12 months)
- Change in physical quality of life at 18 months(Baseline and 18 months)
- Change in weight-related quality of life at 12 months(Baseline and 12 months)
- Change in weight-related quality of life at 18 months(Baseline and 18 months)
- Change in physical quality of life at 6 months(Baseline and 6 months)
- Change in mental quality of life at 12 months(Baseline and 12 months)
- Change in mental quality of life at 18 months(Baseline and 18 months)
- Change in weight-related quality of life at 6 months(Baseline and 6 months)