Activity Level Monitoring Study (ALMS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Morbid Obesity
• Intervention / Treatment: Behavioral: Phone/zoom calls

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Staaby; Phone Number: (614) 688-3895; Email: staaby.1@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional Follow-up; 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; 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.
No Intervention: Activity Level Monitoring; Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	Participants will complete the Perceived Stress Scale	Change from baseline to 6 weeks
Psychological distress	Participants will complete the Hospital and Anxiety Scale	Change from baseline to 6 weeks
Insomnia	Participants will complete the Insomnia Severity Index	Change from baseline to 6 weeks
Sleep quality	Participants will complete the Pittsburgh Sleep Quality Index	Change from baseline to 6 weeks
Pain perception measure 1	Participants will complete the McGill Pain Questionnaire	Change from baseline to 6 weeks
Pain perception measure 2	Participants will complete the Visual Analog Scale for Pain	Change from baseline to 6 weeks
Weight Stigma measure 1	Participants will complete the Stigma Situations Inventory	Change from baseline to 6 weeks
Weight Stigma measure 2	Participants will complete the Weight Bias Internalization Scale	Change from baseline to 6 weeks
Weight Stigma measure 3	Participants will complete the Body Appreciation Scale	Change from baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Charles Emery, PhD, Cardiopulmonary Behavioral Medicine at OSU

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): April 29, 2025
• Study Completion (Estimated): April 29, 2025

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: obesity; Actigraph; sedentary; morbid obesity; activity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2021B0332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes