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临床试验/NCT03685305
NCT03685305已完成不适用

Weight Loss and Cognitive Function in Middle-Aged and Older Adults

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Cognitive function changes - attention

研究概览

简要总结

More than two-thirds of middle-aged and older adults are overweight, which places them at greater risk of disability and higher medical expenses. Lifestyle interventions which promote weight loss for this population are needed. However, it is not known how different weight loss approaches impact brain (cognitive) functions, such as memory and attention. The investigator's investigation aims to improve adherence to a hypocaloric diet prescription through improved attention and inhibitory control, reduced hunger, and increased satiety.

The objectives of this pilot study are to: 1) determine the feasibility and establish proof-of-concept; 2) establish proficiency and feasibility of the proposed cognitive function assessments; and 3) obtain preliminary data for effect size generation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Overweight or obese, BMI 25-40 kg/m^2
  • •Able to use a computer, keyboard, and mouse

排除标准

  • •Uncontrolled hypertension
  • •Orthopedic injury
  • •Other conditions that preclude participation in a walking program
  • •Previous participation in psychology research which involved computerized cognitive testing
  • •Diabetes which requires insulin

研究组 & 干预措施

Hypocaloric diet with hunger reduction strategy

Experimental

Participants will be prescribed a hypocaloric diet with additional instructions to promote hunger reduction. The hypocaloric diet will range 1200-1500 kcal/d, and will be based upon the 2015 US Dietary Guidelines for Americans. Dietary instructions will be provided by a Registered Dietitian.

干预措施: Hypocaloric diet with hunger reduction strategy (Behavioral)

Hypocaloric diet without hunger reduction strategy

Active Comparator

Participants will only be prescribed a hypocaloric diet. The hypocaloric diet will range 1200-1500 kcal/d, and will be based upon the 2015 US Dietary Guidelines for Americans. Dietary instructions will be provided by a Registered Dietitian.

干预措施: Hypocaloric diet without hunger reduction strategy (Behavioral)

结局指标

主要结局

Cognitive function changes - attention

时间窗: 30-min measurement per session

Computerized tasks will score each participant's performance for attention at baseline and after both the 4-week weight loss and weight maintenance phases.

Cognitive function changes - inhibitory control

时间窗: 30-min measurement per session

Computerized tasks will score each participant's performance for inhibitory control at baseline and after both the 4-week weight loss and weight maintenance phases.

Weight change

时间窗: 5-min measurement per session

Weight will be measured on a scale at baseline and after both the 4-week weight loss and weight maintenance phases.

次要结局

  • Perceived hunger(15-minute measurement per session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brenda Davy

Professor

Virginia Polytechnic Institute and State University

研究点 (1)

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