Recruiting

Observational StudyHealthy Living BEYOND Weight Study

Sponsor:

American Heart Association

Code:

NCT07075341

Conditions

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

None - Observational study

Study Details

Brief 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 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.

Conditions

Overweight or Obesity

Study ID

NCT07075341

Start date

Jun 30, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2060

Anticipated

Primary completion date

Dec, 2060

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000000 participants

Anticipated

Interventions and Outcome Measures

Arms

Direct-to-Participant Group

Observational

Interventions

None - Observational study

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 ]
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 ]

Central Contacts and Locations

Locations

American Heart Association

Recruiting

Dallas, Texas, United States, 75231

Contacts

HLBW Study Team

888-242-2222 AHA.HLBW@heart.org

More Information

Sponsor

American Heart Association

Last update posted

Aug 6, 2025

Last verified

Aug, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by American Heart Association on 2025-08-06.