Activity Level Monitoring Study

NCT ID: NCT05379088

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2025-04-29

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.

Detailed Description

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Conditions

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Obesity Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Phone/zoom calls

Intervention Type BEHAVIORAL

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.

Activity Level Monitoring

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Charles Emery PhD

Professor and Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Emery, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiopulmonary Behavioral Medicine at OSU

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2021B0332

Identifier Type: -

Identifier Source: org_study_id

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