Activity Level Monitoring Study (ALMS)

The Ohio State University

Status: Active, not recruiting

Conditions: Obesity; Morbid Obesity

Treatments: Behavioral: Phone/zoom calls

Study type: Interventional

Funder types: Other

Identifiers

NCT05379088

2021B0332

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Additional Follow-up

Experimental group

Description:

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.

Treatment:

Behavioral: Phone/zoom calls

Activity Level Monitoring

No Intervention group

Description:

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