Intentional weight reduction and physical and cognitive function

描述（由申请人提供）：本提案是“有意减轻体重与身体和认知功能”的重新提交。肥胖通过两种直接途径与身体残疾相关（例如，下肢疼痛、肌肉力量不足）和间接途径（肥胖相关的合并症和炎症）。此外，糖尿病是一种与肥胖有关的主要健康状况，与残疾风险增加以及身体和认知功能加速下降有关。我们的初步数据表明，有意减肥可以改善身体功能，并且有强有力的间接证据表明，它也有利于认知功能。为了评估有意减肥对身体和认知功能的作用，我们提出了一项正在进行的Look AHEAD（糖尿病健康行动）试验的辅助研究。Look AHEAD是一项多中心随机临床试验，旨在检查4年生活方式干预的效果，旨在通过减少热量摄入和运动来实现和维持体重减轻，年龄在45-74岁的超重或肥胖男性和女性2型糖尿病患者。我们建议在16个Look AHEAD现场研究中心（科罗拉多、孟菲斯、彭宁顿和匹兹堡）中的4个研究中心的1002名参与者中，在试验的体重维持阶段，在第8年随访访视中增加经验证的和完善的身体和认知能力指标。这项辅助研究的具体目的是：1）确定旨在实现和维持体重减轻的生活方式干预对身体功能的长期影响; 2）确定旨在实现和维持体重减轻的生活方式干预对认知功能的长期影响。此外，我们假设在干预组中，较大的初始体重减轻，更好的体重减轻维持和更高的体力活动将与更好的身体和认知功能相关。我们还假设，在对照组中，体重减轻与体重稳定或体重增加的人相比，身体和认知功能更差。肥胖老年人的数量正在迅速上升，很少有数据来指导基于证据的临床应对措施。这项研究的结果将提供第一个直接证据，证明长期有意减肥对维持老年肥胖糖尿病患者的身体和认知功能的作用。由于本研究是作为一项正在进行的试验的辅助研究进行的，因此可以以及时和具有成本效益的方式进行。

DESCRIPTION (provided by applicant): This proposal is a resubmission of "Intentional weight reduction and physical and cognitive function". Obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health condition, is associated with increased risk of disability and accelerated declines in physical and cognitive function. Our preliminary data suggest that intentional weight loss improves physical function, and there is strong circumstantial evidence that it would also benefit cognitive function. To evaluate the role of intentional weight loss on physical and cognitive function, we propose an ancillary study to the on-going Look AHEAD (Action for Health in Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss through decreased caloric intake and exercise in overweight or obese men and women aged 45-74 years with type 2 diabetes. We propose to add validated and well-established measures of physical and cognitive performance to the year 8 follow-up visit - during the trial's weight maintenance phase - in 1002 participants at 4 of the 16 Look AHEAD field sites (Colorado, Memphis, Pennington and Pittsburgh). The specific aims of this ancillary study are: 1) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on physical function; and 2) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on cognitive function. In addition, we hypothesize that in the intervention group, larger initial weight loss, better weight loss maintenance, and higher physical activity will be associated with better physical and cognitive function. We also hypothesize that in the control group weight loss will be associated with worse physical and cognitive function than in those who are weight stable or who have gained weight. The number of obese older adults is rising rapidly and there are few data to guide an evidence-based clinical response to their management. The results of this study will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. Since this study is being done as an ancillary study to an on-going trial it can be done in a timely and cost-efficient manner.