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临床试验/NCT05379088
NCT05379088已完成不适用

Activity Level Monitoring Study

Ohio State University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年4月11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
38
试验地点
2
主要终点
Physical function

研究概览

简要总结

The purpose of this study is to 1) evaluate the relationship of physical activity to quality of life and psychological functioning among adults with severe obesity (BMI>40) and 2) evaluate the effects of activity monitoring on changes in physical activity during a 6-week intervention interval.

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
None

入排标准

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

入选标准

  • 18 years of age or older
  • BMI greater than or equal to 40
  • Sit or lie down greater than or equal to 9 hours per day

排除标准

  • Participating in regular exercise (any planned exercise)
  • Participating in a formal weight loss or exercise program
  • Planning to join a formal weight loss or exercise program in the next 2 months
  • Cannot stand up without assistance
  • Currently pregnant
  • Planning to get pregnant in the next 2 months
  • Given birth in past 9 months
  • Currently breast feeding
  • Weigh over 400 lbs
  • Highest level of education is below 8th grade
  • PHQ-9 score less than 15
  • Visual impairment that impairs ability to read
  • Any condition(s) that would make it challenging to follow instructions/directions
  • Cognitive disorder (e.g., dementia)

研究组 & 干预措施

Additional Follow-up

Experimental

In addition to receiving an ActiGraph activity monitor, participants will complete weekly phone/zoom calls with research staff for a more in-depth monitoring of their activity level.

干预措施: Phone/zoom calls (Behavioral)

Activity Level Monitoring

No Intervention

Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period.

结局指标

主要结局

Physical function

时间窗: Change from baseline to 6 weeks

Participants will complete a 60-foot walk test and 30-second chair stand test.

Sit to stand transitions

时间窗: Change from baseline to 6 weeks

Participants will wear activity monitors for the duration of the study. The monitors will keep track of every time a participant goes from sitting to standing and vice versa.

Health Related Quality of life

时间窗: Change from baseline to 6 weeks

Participants will complete the Medical Outcomes Survey, Short Form-36

Sedentary time

时间窗: Change from baseline to 6 weeks

Participants will wear activity monitors for the duration of the study. Sedentary time is operationalized as any recorded waking time spent sitting or lying down.

Self-report physical activity

时间窗: Change from baseline to 6 weeks

Participants will complete the Modified International Physical Activity Questionnaire - Short Form

次要结局

  • Psychological distress(Change from baseline to 6 weeks)
  • Weight Stigma measure 3(Change from baseline to 6 weeks)
  • Pain perception measure 1(Change from baseline to 6 weeks)
  • Weight Stigma measure 2(Change from baseline to 6 weeks)
  • Perceived stress(Change from baseline to 6 weeks)
  • Pain perception measure 2(Change from baseline to 6 weeks)
  • Weight Stigma measure 1(Change from baseline to 6 weeks)
  • Insomnia(Change from baseline to 6 weeks)
  • Sleep quality(Change from baseline to 6 weeks)

研究者

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

Charles Emery PhD

Professor and Department Chair

Ohio State University

研究点 (2)

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