Knowledge-based Dietary Weight Management.
2020年4月16日 更新者：Mindy Lee、University of Illinois at Urbana-Champaign
Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.
This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity.
Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management.
Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.
研究概览
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Illinois
-
Urbana、Illinois、美国、61801
- University of Illinois at Urbana-Champaign
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- age 18-64 years;
- body mass index (BMI) >28 kg/m2;
- not currently pregnant or lactating;
- have Wi-Fi at home, a working email, and an iPhone or Android smartphone.
- no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
- not using insulin injection;
- able to attend the 22 (1 hour) diet improvement sessions.
- willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year.
- keep weighing their weight for one and a half years.
- fluent in reading and writing English.
Exclusion criteria:
- age <18 or >64 years;
- body mass index of <28 kg/m2;
- currently pregnant;
- currently lactating;
- self-reported with the severe metabolic, cardiovascular or musculoskeletal disease;
- use insulin injection;
- not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
- failed to set up a Wi-Fi scale;
- failed to submit a food frequency questionnaire
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group
Eligible participants will be in an intervention group led by a registered dietitian
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During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour.
Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss.
The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference.
The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating.
The participants will build skills to select foods and create meals that prevent them from overeating.
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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 |
|---|---|---|
|
Body weight
大体时间：Change from baseline body weight at 6 months
|
Body weight in kilograms
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Change from baseline body weight at 6 months
|
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Body weight
大体时间：Change from baseline body weight at 12 months
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Body weight in kilograms
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Change from baseline body weight at 12 months
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Body weight
大体时间：Change from baseline body weight at 18 months
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Body weight in kilograms
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Change from baseline body weight at 18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Waist circumference
大体时间：Change from baseline waist circumference at 12 months
|
Waist circumference in centimeters
|
Change from baseline waist circumference at 12 months
|
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Hip circumference
大体时间：Change from baseline hip circumference at 12 months
|
Hip circumference in centimeters
|
Change from baseline hip circumference at 12 months
|
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Protein intake
大体时间：Change from baseline protein intake at 6 months
|
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
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Change from baseline protein intake at 6 months
|
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Protein intake
大体时间：Change from baseline protein intake at 12 months
|
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
|
Change from baseline protein intake at 12 months
|
|
Fiber intake
大体时间：Change from baseline fiber intake at 6 months
|
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
|
Change from baseline fiber intake at 6 months
|
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Fiber intake
大体时间：Change from baseline fiber intake at 12 months
|
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
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Change from baseline fiber intake at 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nakamura T Manabu, PhD、University of Illinois at Urbana-Champaign
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月5日
初级完成 (预期的)
2021年4月1日
研究完成 (预期的)
2021年4月1日
研究注册日期
首次提交
2020年4月15日
首先提交符合 QC 标准的
2020年4月16日
首次发布 (实际的)
2020年4月20日
研究记录更新
最后更新发布 (实际的)
2020年4月20日
上次提交的符合 QC 标准的更新
2020年4月16日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
All individual participant data that underlie results in a publication will be shared.
IPD 共享时间框架
Data will be maintained for three years after completion of the study
IPD 共享访问标准
Findings will be disseminated via abstracts and presentations at scientific conferences and through manuscripts and journal articles within the field.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.