Healthy Living BEYOND Weight Study

August 1, 2025 updated by: American Heart Association

The Healthy Living BEYOND Weight Study is an observational research study of participants living with overweight and obesity. The principal objectives for this project will be to answer fundamental unanswered questions regarding patient experiences and outcomes related to overweight and obesity, and to assess the real-world effectiveness of different weight management strategies, within contemporary and diverse populations. To accomplish this, the Study Team for this project will leverage their expertise in the science of obesity and cardiometabolic health; epidemiology, cohort and registry studies; implementation science; cardiovascular prevention and management; and disparities and community-based research to lead the development of an innovative cohort of people living with overweight or obesity with two key components:

  1. patient-report data elements, obtained through surveys;
  2. linkage to EHR records providing data regarding clinical encounters.

The cohort will be inclusive, comprehensive, and constructed with scientific rigor as well as high internal and external validity. An overall objective is for the Healthy Living BEYOND Weight Study is to serve as an enduring resource for researchers studying the health consequences of obesity and evaluating the impact of weight management strategies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity and overweight are presently the leading clinical and public health challenge in the United States. Nationally representative data demonstrates a historically high domestic prevalence of obesity, with a disproportionately high burden in vulnerable populations. There are myriad clinical consequences of obesity, with the most significant adverse impact being premature mortality due to an excess burden of cardiovascular disease. The cardiovascular consequences of overweight and obesity are mediated through cardiovascular-kidney-metabolic syndrome, involving multisystem dysfunction and progressive vascular pathology. While the public health urgency of overweight and obesity is well established, the landscape of obesity management has been revolutionized in recent years by the emergence of increasingly effective and safe obesity pharmacotherapies, in addition to refined approaches to lifestyle modification and bariatric surgery. Clinical trials and observational studies have demonstrated the efficacy of these obesity therapies for inducing weight loss, improving Cardiovascular-Kidney Metabolic (CKM) risk factor profiles and decreasing rates of adverse kidney and cardiovascular events. However, many substantial questions remain regarding the real world and long-term utilization and impact of these therapies, as well as the broader lived experience of individuals living with overweight and obesity. Utilizing direct engagement with participants and the examination of health records, the Healthy Living BEYOND Weight Study is poised to provide important new insights about the health, well-being and approaches to care for persons living with overweight and obesity.

Study Type

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.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • American Heart Association
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals currently residing in the United States

Description

Inclusion Criteria:

  • BMI at the time of enrollment of 25 kg/m2 or greater or other elevated adiposity measures (e.g., waist circumference of greater than 102cm (40 in) in men or 88cm (35 in) in women) OR adults with a BMI less than 25 due to previous or current weight management treatment (lifestyle, pharmacological or surgical).

Exclusion Criteria:

  • Incarcerated at the time of enrollment
  • Self-reported pregnancy at the time of enrollment. However, individuals who become pregnant after enrollment will be welcomed to continue to participate, given that the critical life period of pregnancy often has a significant impact on subsequent weight trajectories.
  • Terminal illness or end-stage disease with a life expectancy of less than 6-months
  • Employed by the American Heart Association or working on the Healthy Living BEYOND Weight Study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Direct-to-Participant Group
Observational
Other: None - Observational study
None - Observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Answer fundamental unanswered questions regarding patient experiences and outcomes related to overweight and obesity.
Time Frame: From enrollment to at least 10 years post enrollment, continuous follow up
From enrollment to at least 10 years post enrollment, continuous follow up
Evaluate the real-world effectiveness of different weight management strategies, within contemporary and diverse patient populations.
Time Frame: From enrollment to at least 10 years post enrollment, continuous follow up
From enrollment to at least 10 years post enrollment, continuous follow up
Create a community of volunteers interested in advancing research on the conditions of overweight/obesity and related weight management strategies.
Time Frame: From enrollment to at least 10 years post enrollment
From enrollment to at least 10 years post enrollment
To provide an enduring resource of value to individuals living with overweight and obesity.
Time Frame: From enrollment to at least 10 years post enrollment
From enrollment to at least 10 years post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Heart Association

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Duke Clinical Research Institute
Evidation Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2060

Study Completion (Estimated)

Study Completion

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 "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2060

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00086052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from surveys will be combined with data from the EHR. Data that are stored in the integrated study database will use unique participant identification numbers, with data otherwise de-identified. We will utilize multiple data quality control processes to ensure the accuracy and reliability of study data. The integrated database will be maintained by the AHA or another service provider that is approved in advance by the IRB. Data collected as part of the Healthy Living BEYOND Weight Study will be used for research purposes only and will not be used for diagnosis or disease management.

IPD Sharing Time Frame

July 2026 - ending 5 years after study close

IPD Sharing Access Criteria

Study participant de-identified data will be accessible by the AHA and organizations doing work on their behalf such as qualified researchers, academic institutions, patient-advocacy groups, pharmaceutical, medical device companies, Evidation Health, Inc., and more. Study participant de-identified data may be used for the following:

  • Determination of clinical Study eligibility and subsequent screening, recruitment and enrollment. If a participant chooses to join a clinical Study for which they are eligible, they may be asked to sign an additional Study-specific consent form.
  • Use for research across a variety of disciplines and for use in scientific publications, interventional and/or product development.

Data will be stored in a HIPAA-compliant, secure electronic platform with access limited to authorized study personnel and authorized researchers with executed data use agreements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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