Activity Monitoring for Obesity

(ALMS Trial)

Overseen By Alice Staaby

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Regular exercise, Weight loss program, Pregnancy, Cognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

38 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Charles Emery, PhD

Principal Investigator

Cardiopulmonary Behavioral Medicine at OSU

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) is very high, which means you are severely overweight.

You spend more than 9 hours a day sitting or lying down.

Exclusion Criteria

Cannot stand up without assistance

Currently pregnant

Planning to get pregnant in the next 2 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Activity Monitoring

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

6 weeks

Weekly phone/zoom calls for in-depth monitoring

Follow-up

Participants are monitored for changes in physical activity, quality of life, and psychological functioning

4 weeks

Treatment Details

Interventions

• Phone/zoom calls

Trial Overview 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.

Participant Groups

Group I: Additional Follow-up Experimental Treatment 1 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 Monitoring Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+