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Activity Monitoring for Obesity (ALMS Trial)
N/A
Waitlist Available
Led By Charles Emery, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test how physical activity impacts quality of life and mental health for people with severe obesity, and how monitoring activity affects physical activity.
Who is the study for?
This study is for adults with severe obesity (BMI over 40) who sit or lie down for most of the day (9+ hours). It's not suitable for those who can't stand without help, are currently pregnant or gave birth recently, have low education levels, suffer from depression, weigh over 400 lbs, have cognitive disorders like dementia, visual impairments that affect reading ability, or are already exercising regularly.
What is being tested?
The trial aims to see how tracking physical activity affects quality of life and mental health in severely obese individuals. Participants will be monitored through phone or Zoom calls over a six-week period to assess changes in their activity levels.
What are the potential side effects?
Since this intervention involves monitoring rather than medication or surgery, there aren't typical medical side effects. However, participants may experience psychological discomfort from being observed and possibly stress if they struggle to increase their activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Health Related Quality of life
Physical function
Sedentary time
+2 moreSecondary study objectives
Insomnia
Pain perception measure 1
Pain perception measure 2
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Additional Follow-upExperimental Treatment1 Intervention
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.
Group II: Activity Level MonitoringActive Control1 Intervention
Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,701 Total Patients Enrolled
23 Trials studying Obesity
3,936 Patients Enrolled for Obesity
Charles Emery, PhDPrincipal InvestigatorCardiopulmonary Behavioral Medicine at OSU