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临床试验/NCT04490356
NCT04490356已完成不适用

A Novel Telehealth Intervention Using Nutrition and Exercise to Extend Intervention Benefits: Enhancing Physical Function in the Long-term for Obese Older Adults

Duke University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Acceptability as Measured by Participant Satisfaction

研究概览

简要总结

The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The "Legacy Intervention" will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters
  • Able to speak and understand spoken and written English.
  • Able to record dietary intake and weight

排除标准

  • Presence of unstable or symptomatic life-threatening illness
  • Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke
  • Inability to complete physical function assessment
  • No access to internet connection to participate in the tele-intervention
  • Unable or unwilling to use provided tablet to participant in tele-intervention
  • History of cognitive impairment

结局指标

主要结局

Acceptability as Measured by Participant Satisfaction

时间窗: 12 week endpoint

Participants will asked to rate their satisfaction by answering the question "Overall, I'm glad I participated in this weight maintenance program" with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction

Proportion Retention

时间窗: 12 week endpoint

Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants

次要结局

  • Change in Physical Performance as Measured by the Short Physical Performance Battery(0 weeks, 12 weeks)
  • Change in Physical Function as Measured Using the 6 Minute Walk Test(0 weeks, 12 weeks)
  • Change in Body Weight as Measured by the Aria Fitbit Scale(0 weeks, 12 weeks)
  • Change in Average Weekly Steps Measured Using Garmin Watch(0 weeks, 12 weeks)
  • Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)(0 weeks,12 weeks)
  • Change in Stress Using the Perceived Stress Scale(0 weeks, 12 weeks)
  • Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)(0 weeks, 12 weeks)
  • Change in Mood Using the Profile of Mood States Questionnaire(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - Pain Scale(0 weeks, 12 weeks)
  • Quality of Life Using the SF-36 Questionnaire - General Health Scale(0 weeks, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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