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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05379088
Other study ID # 2021B0332
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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