Activity Level Monitoring Study

NCT05379088 | Completed

• 1 other identifier: 2021B0332
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Morbid Obesity

Keywords

sedentary; activity; morbid obesity; obesity; Actigraph

Outcome Measures

Primary Outcomes (5)

• Sedentary time

  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.

  Change from baseline to 6 weeks

• Sit to stand transitions

  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.

  Change from baseline to 6 weeks

• Self-report physical activity

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

  Change from baseline to 6 weeks

• Physical function

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

  Change from baseline to 6 weeks

• Health Related Quality of life

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

  Change from baseline to 6 weeks

Secondary Outcomes (9)

• Perceived stress

  Change from baseline to 6 weeks

• Psychological distress

  Change from baseline to 6 weeks

• Insomnia

  Change from baseline to 6 weeks

• Sleep quality

  Change from baseline to 6 weeks

• Pain perception measure 1

  Change from baseline to 6 weeks

Study Arms (2)

Additional Follow-up

EXPERIMENTAL

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.

Behavioral: Phone/zoom calls

Activity Level Monitoring

NO INTERVENTION

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

Interventions

Phone/zoom calls BEHAVIORAL

Participants will complete weekly follow-up phone/zoom calls with a member of the research team. The phone/zoom calls will typically last 30-60 minutes. Participants will discuss barriers to activity and goals for upcoming weeks.

Additional Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Charles Emery, PhD

  Cardiopulmonary Behavioral Medicine at OSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Chair

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 18, 2022
• Study Start: April 11, 2022
• Primary Completion: April 29, 2025
• Study Completion: August 29, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)