Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Effect of Weekly Communications on Adherence and Program Efficacy
研究概览
简要总结
This research is examining whether an 8-week online nutritional programming based on a Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and improvements in measures of body weight and laboratory measures of oxidative stress, a risk marker for cardiovascular disease. This study will also examine whether weekly short support and communication from a medical assistant (MA) in a primary care setting in addition to the online program will result in better program adherence and have a positive impact on health.
详细描述
Eligible participants will be identified by primary care providers or their staff at clinical outpatient site(s). Study is 3-arm randomized control trial where participants will be randomized to 1) Control group (CTL)-will not receive access to online program nor intervention for first 12 weeks; 2) GFFY-1-will receive access to online program without MA intervention 3) GFFY-2-will receive access to online program and MA intervention with weekly phone call. The core of the intervention is an 8-week Mediterranean diet and behavioral online program called "Go! Foods for You (GFFY)" which is offered on the Cleveland Clinic's 360.5.com website. The research will last for 24 weeks. Questionnaire data and biometric measurements will be collected at pre and post intervention (0-8 weeks) and at followup (12 and 24 weeks). Regardless of randomization, participants will be asked to provide their weight every week and an activity log at the end of each week of the program. A urine sample to measure F2-isoprostane will be collected at week 0 and 12 for GFFY-2 and CTL groups.
A preparatory phase requiring the involvement of MAs to provide weekly support to participants is necessary to test process and communication with MAs. Enrollment of 10-20 volunteers for the preparatory phase is desired. Data collected during this phase will not be part of study analysis. To test data collection process, we may ask a few participants to complete baseline questionnaire only.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 25 or greater.
- •Age 18 to 70 years old.
- •Patient of a participating Internal Medicine or Family Medicine primary care provider at a Cleveland Clinic Family Health Center.
- •Registered on the Cleveland Clinic's electric medical records, My Chart.
排除标准
- •Women who are pregnant or planning to be pregnant in the next 6 months.
- •No easy internet and email access at place of residence.
- •No access to a scale at place of residence for weekly weight measurement.
- •Sudden unintentional weight loss or weight gain in the past 3 months due to medical illness
- •Currently involved in a weight loss program
- •unwilling to be in the wait-list control group where participant will not have access to the program for 3 months
- •unwilling to log onto the internet on a regular basis for the duration of the study (3-4 months)
结局指标
主要结局
Effect of Weekly Communications on Adherence and Program Efficacy
时间窗: 12 weeks
To see if extension of the patient/medical provider relationship through weekly emails by a medical assistant who addresses the program behavioral goals set by the patient leads to greater weight loss.
Weight Loss
时间窗: 12 weeks
To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.
次要结局
- Effect on Oxidative Stress(12 weeks)
- Correlation between MA Support and Program Utilization(12 weeks)
- Dietary Improvements(12 weeks)
- Increase in Intake of a Mediterranean-based Diet(12 weeks)
- Sustainability of Weight Loss(24 weeks)
- Effect on Physical and Mental Health(12 weeks)
研究者
Linda Libertini
Research Coordinator
The Cleveland Clinic