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Clinical Trials/NCT05379088
NCT05379088
Completed
Not Applicable

Activity Level Monitoring Study

Ohio State University2 sites in 1 country38 target enrollmentApril 11, 2022

Overview

Phase
Not Applicable
Intervention
Phone/zoom calls
Conditions
Obesity
Sponsor
Ohio State University
Enrollment
38
Locations
2
Primary Endpoint
Physical function
Status
Completed
Last Updated
10 days ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2022
End Date
August 29, 2025
Last Updated
10 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charles Emery PhD

Professor and Department Chair

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Additional Follow-up

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.

Intervention: Phone/zoom calls

Activity Level Monitoring

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

Outcomes

Primary Outcomes

Physical function

Time Frame: Change from baseline to 6 weeks

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

Sit to stand transitions

Time Frame: 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

Time Frame: Change from baseline to 6 weeks

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

Sedentary time

Time Frame: 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

Time Frame: Change from baseline to 6 weeks

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

Secondary Outcomes

  • 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)

Study Sites (2)

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