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Information provided by:
The Cleveland Clinic
Last updated:
11/04/2022
Trial identifier:
NCT04531176
DisclaimerStudy Description
Brief summary:
This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight Management Program) augmented by AOMs, vs. an obesity-centric approach with a medically-supervised and comprehensive weight loss program without AOMs, vs. the current usual care approach to general health management. Informed consent will be obtained. IRB approval of the study will be obtained. 300 subjects (employees or spouses covered by our EHP) will be randomized 1:1:1 to receive either an obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM therapy (N=100), or the current usual care approach to general health management (N=100).
Study Recruitment Status:
Glossary term:
Recruitment status
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
Glossary term:
Age Eligible:
Glossary term:
Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:
The age groups are:
Child (birth–17)
Adult (18–64)
Older adult (65+)
Glossary term:
Sexes Eligible:
Glossary term:
Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
Glossary term:
Study Accepts Healthy Volunteers:
Glossary term:
Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
Glossary term:
Intervention Being Studied:
Type of Study:
Glossary term:
Study Type
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study.
Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Glossary term:
Enrollment (Actual):
Glossary term:
Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
Glossary term:
Sponsor:
Glossary term:
Sponsor
The organization or person who initiates the study and who has authority and control over the study.
Glossary term:
Study Locations (1):
Study Start Date
(Actual):
Glossary term:
Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.
Glossary term:
September 01, 2020
Study Completion
(Anticipated):
Glossary term:
Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
Glossary term:
March 01, 2023
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