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Activity Level Monitoring Study (ALMS)

Primary Purpose

Obesity, Morbid Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone/zoom calls
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring sedentary, activity, morbid obesity, obesity, Actigraph

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Additional Follow-up

Activity Level Monitoring

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
Self-report physical activity
Participants will complete the Modified International Physical Activity Questionnaire - Short Form
Physical function
Participants will complete a 60-foot walk test and 30-second chair stand test.
Health Related Quality of life
Participants will complete the Medical Outcomes Survey, Short Form-36

Secondary Outcome Measures

Perceived stress
Participants will complete the Perceived Stress Scale
Psychological distress
Participants will complete the Hospital and Anxiety Scale
Insomnia
Participants will complete the Insomnia Severity Index
Sleep quality
Participants will complete the Pittsburgh Sleep Quality Index
Pain perception measure 1
Participants will complete the McGill Pain Questionnaire
Pain perception measure 2
Participants will complete the Visual Analog Scale for Pain
Weight Stigma measure 1
Participants will complete the Stigma Situations Inventory
Weight Stigma measure 2
Participants will complete the Weight Bias Internalization Scale
Weight Stigma measure 3
Participants will complete the Body Appreciation Scale

Full Information

First Posted
April 27, 2022
Last Updated
September 19, 2022
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05379088
Brief Title
Activity Level Monitoring Study
Acronym
ALMS
Official Title
Activity Level Monitoring Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity
Keywords
sedentary, activity, morbid obesity, obesity, Actigraph

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional Follow-up
Arm Type
Experimental
Arm Description
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.
Arm Title
Activity Level Monitoring
Arm Type
No Intervention
Arm Description
Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period.
Intervention Type
Behavioral
Intervention Name(s)
Phone/zoom calls
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sedentary time
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Sit to stand transitions
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Self-report physical activity
Description
Participants will complete the Modified International Physical Activity Questionnaire - Short Form
Time Frame
Change from baseline to 6 weeks
Title
Physical function
Description
Participants will complete a 60-foot walk test and 30-second chair stand test.
Time Frame
Change from baseline to 6 weeks
Title
Health Related Quality of life
Description
Participants will complete the Medical Outcomes Survey, Short Form-36
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Perceived stress
Description
Participants will complete the Perceived Stress Scale
Time Frame
Change from baseline to 6 weeks
Title
Psychological distress
Description
Participants will complete the Hospital and Anxiety Scale
Time Frame
Change from baseline to 6 weeks
Title
Insomnia
Description
Participants will complete the Insomnia Severity Index
Time Frame
Change from baseline to 6 weeks
Title
Sleep quality
Description
Participants will complete the Pittsburgh Sleep Quality Index
Time Frame
Change from baseline to 6 weeks
Title
Pain perception measure 1
Description
Participants will complete the McGill Pain Questionnaire
Time Frame
Change from baseline to 6 weeks
Title
Pain perception measure 2
Description
Participants will complete the Visual Analog Scale for Pain
Time Frame
Change from baseline to 6 weeks
Title
Weight Stigma measure 1
Description
Participants will complete the Stigma Situations Inventory
Time Frame
Change from baseline to 6 weeks
Title
Weight Stigma measure 2
Description
Participants will complete the Weight Bias Internalization Scale
Time Frame
Change from baseline to 6 weeks
Title
Weight Stigma measure 3
Description
Participants will complete the Body Appreciation Scale
Time Frame
Change from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Staaby
Phone
(614) 688-3895
Email
staaby.1@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Emery, PhD
Organizational Affiliation
Cardiopulmonary Behavioral Medicine at OSU
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Staaby
Phone
614-688-3895
Email
stressstudies@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Activity Level Monitoring Study

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