Effectiveness of an Eight Week Online Mediterranean Based Diet
Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population
研究概览
地位
条件
详细说明
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.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control Group
No intervention provided.
These participants will receive access to the Go! Foods for You program after the research trial has been completed (12 weeks after registration).
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有源比较器：GFFY-1 without weekly MA support
Utilization of the 8-week online nutrition program Go! Foods for You without weekly contact from staff at the medical provider's office.
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有源比较器：GFFY-2 with weekly MA support
Utilization of the 8-week online nutrition program combined with weekly contact from the staff at the medical provider's office.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight Loss
大体时间：12 weeks
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To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.
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12 weeks
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Effect of Weekly Communications on Adherence and Program Efficacy
大体时间：12 weeks
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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.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effect on Oxidative Stress
大体时间：12 weeks
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To see if the program reduces bio markers of oxidative stress (F2 isoprostanes) for participants in the GFFY-2 compared to the CTL group.
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12 weeks
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Correlation between MA Support and Program Utilization
大体时间：12 weeks
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To see if participation in GFFY with MA support can improve program participation as measured by 8-week program completion rate and average weekly activities completed during the 8-week program.
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12 weeks
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Effect on Physical and Mental Health
大体时间：12 weeks
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To see if an 8-week Mediterranean diet online program help improve overall physical and mental health as measured by the RAND Corporation Health Survey tool (SF36Rand).
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12 weeks
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Sustainability of Weight Loss
大体时间：24 weeks
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To see if weight loss from participation in the GFFY programs is sustained at 24 weeks (6 months) follow-up.
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24 weeks
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Dietary Improvements
大体时间：12 weeks
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To see if participation in GFFY increases fiber intake, percentage fat and fruit and vegetable consumption as measured by a brief online food screening questionnaire
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12 weeks
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Increase in Intake of a Mediterranean-based Diet
大体时间：12 weeks
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To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.
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12 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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