ObesityALMSNCT05379088
Activity Level Monitoring Study
A study testing Phone/zoom calls in people with Obesity and Morbid Obesity, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Phone/zoom calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Phone/zoom calls
- Keywords
- sedentary, activity, morbid obesity, obesity, Actigraph
- Medical subject headings
- Obesity, Obesity, Morbid, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone/zoom callsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Additional Follow-up | Experimental | 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. Receives: Behavioral: Phone/zoom calls |
| Activity Level Monitoring | No intervention | Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 6 weeks
Self-report physical activity
Participants will complete the Modified International Physical Activity Questionnaire - Short Form
Measured: Change from baseline to 6 weeks
Physical function
Participants will complete a 60-foot walk test and 30-second chair stand test.
Measured: Change from baseline to 6 weeks
Health Related Quality of life
Participants will complete the Medical Outcomes Survey, Short Form-36
Measured: Change from baseline to 6 weeks
Secondary outcomes (9)
Perceived stress
Participants will complete the Perceived Stress Scale
Measured: Change from baseline to 6 weeks
Psychological distress
Participants will complete the Hospital and Anxiety Scale
Measured: Change from baseline to 6 weeks
Insomnia
Participants will complete the Insomnia Severity Index
Measured: Change from baseline to 6 weeks
Sleep quality
Participants will complete the Pittsburgh Sleep Quality Index
Measured: Change from baseline to 6 weeks
Pain perception measure 1
Participants will complete the McGill Pain Questionnaire
Measured: Change from baseline to 6 weeks
Pain perception measure 2
Participants will complete the Visual Analog Scale for Pain
Measured: Change from baseline to 6 weeks
Weight Stigma measure 1
Participants will complete the Stigma Situations Inventory
Measured: Change from baseline to 6 weeks
Weight Stigma measure 2
Participants will complete the Weight Bias Internalization Scale
Measured: Change from baseline to 6 weeks
Weight Stigma measure 3
Participants will complete the Body Appreciation Scale
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start11 Apr 2022
- Primary completion29 Apr 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Emery PhD, Ohio State University
- Investigators
- Charles Emery, PhD, Principal investigator, Cardiopulmonary Behavioral Medicine at OSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379088
- Sponsor's protocol ID
- 2021B0332
- Acronym
- ALMS
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Level Monitoring Study
- ClinicalTrials.gov ID
- NCT05379088
- Acronym / sponsor ID
- ALMS / 2021B0332
- Conditions
- Obesity, Morbid Obesity
- Keywords
- sedentary, activity, morbid obesity, obesity, Actigraph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional Follow-up | Experimental | Behavioral: Phone/zoom callsIn 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. |
| Activity Level Monitoring | No intervention | –Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone/zoom callsParticipants 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. | Behavioural | Additional Follow-up |
Primary outcome
Sedentary time
Time frame: Change from baseline to 6 weeks
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
Time frame: Change from baseline to 6 weeks
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
Time frame: Change from baseline to 6 weeks
Participants will complete the Modified International Physical Activity Questionnaire - Short Form
Physical function
Time frame: Change from baseline to 6 weeks
Participants will complete a 60-foot walk test and 30-second chair stand test.
Health Related Quality of life
Time frame: Change from baseline to 6 weeks
Participants will complete the Medical Outcomes Survey, Short Form-36
9 secondary outcomes
Perceived stress
Time frame: Change from baseline to 6 weeks
Psychological distress
Time frame: Change from baseline to 6 weeks
Insomnia
Time frame: Change from baseline to 6 weeks
Sleep quality
Time frame: Change from baseline to 6 weeks
Pain perception measure 1
Time frame: Change from baseline to 6 weeks
Pain perception measure 2
Time frame: Change from baseline to 6 weeks
Weight Stigma measure 1
Time frame: Change from baseline to 6 weeks
Weight Stigma measure 2
Time frame: Change from baseline to 6 weeks
Weight Stigma measure 3
Time frame: Change from baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Emery, PhD principal investigator
Cardiopulmonary Behavioral Medicine at OSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone/zoom calls in people with Obesity and Morbid Obesity, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (time frame: Change from baseline to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.