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临床试验/NCT01410097
NCT01410097已完成不适用

Intentional Weight Reduction and Physical and Cognitive Function - A Look AHEAD Ancillary Study

Wake Forest University4 个研究点 分布在 1 个国家目标入组 1,089 人开始时间: 2009年9月1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
1,089
试验地点
4
主要终点
Short Physical Performance Battery (SPPB) Score

研究概览

简要总结

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. The investigators 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, the investigators 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. The investigators 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 ~1000 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, the investigators 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. The investigators 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The only inclusion criterion is that the participant is considered "active" at his/her Year 8 or Year 9 visit in the main study.

排除标准

  • •The only exclusion criterion is the person is not willing to participate in this ancillary study.

研究组 & 干预措施

Lifestyle intervention

Experimental

Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.

干预措施: Lifestyle intervention (Behavioral)

Diabetes Support and Education (DSE)

Placebo Comparator

It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.

干预措施: Diabetes Support Education (Behavioral)

结局指标

主要结局

Short Physical Performance Battery (SPPB) Score

时间窗: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

The Short Physical Performance Battery (SPPB) was administered to assess lower extremity physical performance and consisted of standing balance tasks (side-by-side, semi- and full-tandem stands for 10 seconds each), time to complete 5 repeated chair stands, and a 6-m walk to assess usual gait speed. Each of the three performance measures was assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.

次要结局

  • Knee Extensor Strength(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Modified Mini-Mental Status Exam (3MS)(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Trail Making Test (Part A & B)(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Gait Speed Over 400 m(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Grip Strength(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Modified Stroop Color and Word Test(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Digit Symbol Substitution Test (DSST)(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)
  • Rey Auditory Verbal Learning Test (RAVLT)(Assessed 8 or 9 years post-randomization in Look AHEAD parent Study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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