Intentional weight reduction and physical and cognitive function

说明(申请人提供)：本提案是对“意向减肥及身体和认知功能”的重新提交。肥胖通过直接途径(例如，下肢疼痛、肌肉力量不足)和间接途径(与肥胖有关的合并症和炎症)与身体残疾有关。此外，糖尿病是与肥胖相关的一种主要健康状况，它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，而且有强有力的间接证据表明，它也会有利于认知功能。为了评估有意减肥对身体和认知功能的作用，我们建议对正在进行的前瞻(糖尿病健康行动)试验进行一项辅助研究。展望未来是一项多中心的随机临床试验，旨在检验为期4年的生活方式干预的效果，该干预旨在通过减少超重或肥胖的2型糖尿病患者的卡路里摄入量和运动来实现和保持减肥。我们建议在试验的体重维持阶段对16个前瞻现场(科罗拉多、孟菲斯、彭宁顿和匹兹堡)中的4个地点的1002名参与者进行第8年的后续访问，增加经过验证和完善的身体和认知表现测量。这项辅助研究的具体目标是：1)确定旨在实现和保持减肥对身体功能的生活方式干预的长期影响；以及2)确定旨在实现和保持减肥对认知功能的生活方式干预的长期影响。此外，我们假设，在干预组中，更大的初始体重减轻，更好的减肥维持，以及更多的体力活动将与更好的身体和认知功能相关。我们还假设，与体重稳定或体重增加的人相比，控制组的体重减轻与更差的身体和认知功能有关。肥胖老年人的数量正在迅速上升，几乎没有数据来指导对他们的管理做出循证的临床反应。这项研究的结果将提供第一个直接证据，证明长期故意减肥在维持患有糖尿病的老年肥胖成年人的身体和认知功能方面的作用。由于这项研究是作为正在进行的试验的辅助研究进行的，因此可以及时和具有成本效益的方式进行。公共卫生相关性：鉴于肥胖症和糖尿病在老年人中的高患病率，显然有必要更好地了解有意减肥的功能影响。这项建议利用了现有的干预研究--展望试验，将以有效和具有成本效益的方式促进我们的理解。

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. PUBLIC HEALTH RELEVANCE: Given the high prevalence of obesity and diabetes in older adults, there is a clear public health imperative to better understand the functional implications of intentional weight loss. This proposal, taking advantage of an existing intervention study, the Look AHEAD trial, will advance our understanding in an efficient and cost- effective manner.