Activity Level Monitoring Study

Study Overview
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Brief Summary
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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.

Official Title
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Activity Level Monitoring Study

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Behavioral: Phone/zoom calls


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary, activity, morbid obesity, obesity, Actigraph