Mediterranean Diet, Weight Loss, and Cognition in Obese Older Adults
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60608
- University of Illinois at Chicago
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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:
- Men and women ≥ 55 years of age],
- BMI 30.0-50.0 kg/m2,
- English speaking
- Have access to a phone
- Plan to reside in the Chicago area for the following 14 months
- Minimal levels of cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) < 19.
Exclusion Criteria:
- The exclusion criteria ensure that participants can safely participate in the trial.
- renal disease
- autoimmune disorder
- immunodeficiency
- malabsorptive disorder
- gastrointestinal and hepatic diseases
- severe ischemic heart disease
- severe pulmonary disease
- bariatric surgery
- alcohol abuse (> 50 grams/day) or illicit drug abuse
- uncontrolled diabetes based on capillary hemoglobin A1c (HbA1c) > 9.0%
- schizophrenia or bipolar disorder
- cancer treatment within the past 12 months
- weight > 450 lbs. (due to the weight limitation of the DXA scanner)
- diagnosed sleep apnea and regularly using a cpap machine
- currently adhering to a MedDiet, Montreal Cognitive Assessment (MoCA) < 19,(161) -
- currently on a weight-loss diet or actively involved in a formal weight loss program (e.g., Weight Watchers.)
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:MedDiet-WL
MedDiet-WL group, advice and exchange lists will be designed to promote a 1-2 lb. per week weight loss (approximately 30% caloric restriction or a reduction of about 600 calories per day) for an end goal of a 7% weight loss from baseline.
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Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
实验性的:MedDiet-A
For the MedDiet-A group, dietary advice and corresponding exchange lists will be given within the context of promoting weight stability.
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Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
其他:Typical Diet Control (TDC)
Typical Diet Control (TDC) will maintain current eating and activity patterns and weight over 14 months.
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Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
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 |
---|---|---|
Assessing change in Attention between time periods
大体时间:14 months
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Baseline, 8-month (first intervention), and 14-month assessments will include Digit Symbol test.
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14 months
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Assessing change in Executive Function between time periods
大体时间:14 months
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Baseline, 8-month (first intervention), and 14-month assessments will include the Trail Making Test Part B.
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14 months
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Assessing change in Memory between time periods
大体时间:14 months
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Baseline, 8-month (first intervention), and 14-month assessments will include tests of memory including the delayed free recall from the Hopkins Verbal Learning Test.
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14 months
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合作者和调查者
调查人员
- 首席研究员:Marian Fitzgibbon, PhD、UIC
出版物和有用的链接
一般刊物
- Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial. Trials. 2021 Jul 16;22(1):459. doi: 10.1186/s13063-021-05383-6.
- Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE). Res Sq. 2021 Apr 26:rs.3.rs-290482. doi: 10.21203/rs.3.rs-290482/v1. Preprint.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
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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MedDiet的临床试验
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Laval UniversityCanadian Institutes of Health Research (CIHR)招聘中
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Associacao para Investigacao e Desenvolvimento...University of Lisbon; Fundação para a Ciência e a Tecnologia; Instituto Politécnico de Leiria招聘中