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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 weeks for reporting.

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 more

Secondary study objectives

Insomnia

Pain perception measure 1

Pain perception measure 2

+6 more

Awards & 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.

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