Feasibility, Implementation, and Efficacy of a Plant-based Online Weight Loss Through Education and Resources Program and Study (POWER Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The feasibility of an online plant-based weight loss program in the community setting.
研究概览
简要总结
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will meet with a physician and a registered dietitian once a week to learn about a plant-based diet and receive support and practical help in making the dietary changes. Body composition, blood sugar control, cholesterol levels, and food costs will be measured at the start and end of the study.
详细描述
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will participate in weekly physician- and dietitian-lead group classes and will receive education about a plant-based diet as well as support and practical tips for implementing the dietary changes. Participants will receive baseline and 12 week assessments including a DXA scan to assess body composition, HbA1c, lipid panel, and a food cost analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •U.S. men and women meeting the age of majority, defined as follows:
- •Age 19 or older in Nebraska and Alabama. Age 21 or older in Puerto Rico. Age 18 or older in all other states.
- •Able and willing to travel to Washington DC for a dual-energy х-rау absorptiometry (DXA) scans before and after the program.
- •Able and willing to complete laboratory assessments at a local LabCorp facility before and after the program.
- •Able and willing to participate in all components of the study.
- •BMI of 25 or more (23 or more in persons of Asian origin).
- •Access to the internet.
- •English fluency.
排除标准
- •Use of recreational drugs in the past 6 months.
- •Pregnancy or intention to become pregnant during the study period, as verified by self-report.
- •Unstable medical or psychiatric illness.
- •Inability to maintain medication regimen as prescribed by personal healthcare provider.
- •Current or expected use of any weight loss medication during the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
- •Use of any weight loss medication within the 12 months preceding the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
- •Body weight greater than 182 kg.
- •Current diagnosis of eating disorder.
- •Intention to follow another weight loss method during the study period.
研究组 & 干预措施
Low-fat, vegan diet
All participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group.
干预措施: Low-fat, vegan diet (Behavioral)
结局指标
主要结局
The feasibility of an online plant-based weight loss program in the community setting.
时间窗: From baseline to the end of the intervention at 12 weeks.
Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments.
次要结局
- Changes in glycated hemoglobin.(From baseline to the end of the intervention at 12 weeks.)
- Changes in total and LDL cholesterol levels.(From baseline to the end of the intervention at 12 weeks.)
- Changes in body composition.(From baseline to the end of the intervention at 12 weeks.)
- Food costs of a baseline diet and a low-fat plant-based diet.(From baseline to the end of the intervention at 12 weeks.)