Activity Level Monitoring Study

Obesity Clinical Trial

— ALMS  

Official title:

Activity Level Monitoring Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379088
• Other study ID #: 2021B0332
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: April 29, 2025

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: April 29, 2025
• Est. primary completion date: April 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Self-report physical activity	Participants will complete the Modified International Physical Activity Questionnaire - Short Form	Change from baseline to 6 weeks
Primary	Physical function	Participants will complete a 60-foot walk test and 30-second chair stand test.	Change from baseline to 6 weeks
Primary	Health Related Quality of life	Participants will complete the Medical Outcomes Survey, Short Form-36	Change from baseline to 6 weeks
Secondary	Perceived stress	Participants will complete the Perceived Stress Scale	Change from baseline to 6 weeks
Secondary	Psychological distress	Participants will complete the Hospital and Anxiety Scale	Change from baseline to 6 weeks
Secondary	Insomnia	Participants will complete the Insomnia Severity Index	Change from baseline to 6 weeks
Secondary	Sleep quality	Participants will complete the Pittsburgh Sleep Quality Index	Change from baseline to 6 weeks
Secondary	Pain perception measure 1	Participants will complete the McGill Pain Questionnaire	Change from baseline to 6 weeks
Secondary	Pain perception measure 2	Participants will complete the Visual Analog Scale for Pain	Change from baseline to 6 weeks
Secondary	Weight Stigma measure 1	Participants will complete the Stigma Situations Inventory	Change from baseline to 6 weeks
Secondary	Weight Stigma measure 2	Participants will complete the Weight Bias Internalization Scale	Change from baseline to 6 weeks
Secondary	Weight Stigma measure 3	Participants will complete the Body Appreciation Scale	Change from baseline to 6 weeks