Overweight or ObesityNCT07075341
Healthy Living BEYOND Weight Study
An observational study of Overweight or Obesity, run by American Heart Association at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- None - Observational study
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to Dec 2060
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals currently residing in the United States
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Heart Association
Dallas, Texas, 75231
HLBW Study Team, 888-242-2222, AHA.HLBW@heart.org
About this study
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:
- patient-report data elements, obtained through surveys;
- 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.
Read the 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.
- Conditions
- Overweight or Obesity
- Being tested
- None - Observational study
- Keywords
- overweight, obesity, weight management, BMI, cardiovascular disease, Cardiovascular-Kidney Metabolic, CVD, CKM, GLP-1 RA, glucagon-like peptide-1, GLP-1, GLP-1 receptor agonists, bariatric
- Medical subject headings
- Overweight, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - Observational studyOther
None - Observational study
| Study group | Role | What they receive |
|---|---|---|
| Direct-to-Participant Group | Observational Receives: Other: None - Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Answer fundamental unanswered questions regarding patient experiences and outcomes related to overweight and obesity.
Measured: 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.
Measured: 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.
Measured: From enrollment to at least 10 years post enrollment
To provide an enduring resource of value to individuals living with overweight and obesity.
Measured: From enrollment to at least 10 years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start30 Jun 2025
- Primary completionDec 2060 (estimated)
- Study completionDec 2060 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- Evidation Health, Duke Clinical Research Institute, Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075341
- Sponsor's protocol ID
- Pro00086052
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living BEYOND Weight Study
- ClinicalTrials.gov ID
- NCT07075341
- Acronym / sponsor ID
- Pro00086052
- Conditions
- Overweight or Obesity
- Keywords
- overweight, obesity, weight management, BMI, cardiovascular disease, Cardiovascular-Kidney Metabolic, CVD, CKM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Collaborators
- Evidation Health, Duke Clinical Research Institute, Johns Hopkins University
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Dec 2060 (estimated)
- Study completion
- Dec 2060 (estimated)
- First posted
- 20 Jul 2025 (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 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:
- patient-report data elements, obtained through surveys;
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct-to-Participant Group | – | Other: None - Observational studyObservational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals currently residing in the United States
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| None - Observational studyNone - Observational study | Other | Direct-to-Participant Group |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Overweight or Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
RecruitingPhase 2
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Obesity, Overweight
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight or Obesity, run by American Heart Association 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 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 6 Aug 2025.