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Activity Level Monitoring Study

Activity Level Monitoring Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05379088
Acronym
ALMS
Enrollment
38
Registered
2022-05-18
Start date
2022-04-11
Completion date
2025-08-29
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Obesity

Keywords

sedentary, activity, morbid obesity, obesity, Actigraph

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.

Interventions

BEHAVIORALPhone/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.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Sedentary timeChange from baseline to 6 weeksParticipants 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 transitionsChange from baseline to 6 weeksParticipants 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 activityChange from baseline to 6 weeksParticipants will complete the Modified International Physical Activity Questionnaire - Short Form
Physical functionChange from baseline to 6 weeksParticipants will complete a 60-foot walk test and 30-second chair stand test.
Health Related Quality of lifeChange from baseline to 6 weeksParticipants will complete the Medical Outcomes Survey, Short Form-36

Secondary

MeasureTime frameDescription
Perceived stressChange from baseline to 6 weeksParticipants will complete the Perceived Stress Scale
Psychological distressChange from baseline to 6 weeksParticipants will complete the Hospital and Anxiety Scale
InsomniaChange from baseline to 6 weeksParticipants will complete the Insomnia Severity Index
Sleep qualityChange from baseline to 6 weeksParticipants will complete the Pittsburgh Sleep Quality Index
Pain perception measure 1Change from baseline to 6 weeksParticipants will complete the McGill Pain Questionnaire
Pain perception measure 2Change from baseline to 6 weeksParticipants will complete the Visual Analog Scale for Pain
Weight Stigma measure 1Change from baseline to 6 weeksParticipants will complete the Stigma Situations Inventory
Weight Stigma measure 2Change from baseline to 6 weeksParticipants will complete the Weight Bias Internalization Scale
Weight Stigma measure 3Change from baseline to 6 weeksParticipants will complete the Body Appreciation Scale

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCharles Emery, PhD

Cardiopulmonary Behavioral Medicine at OSU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026