Healthy Living BEYOND Weight Study

NCT07075341 | Recruiting

• 1 other identifier: Pro00086052
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight or Obesity

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

Outcome Measures

Primary Outcomes (4)

• Answer fundamental unanswered questions regarding patient experiences and outcomes related to overweight and obesity.

  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.

  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.

  From enrollment to at least 10 years post enrollment

• To provide an enduring resource of value to individuals living with overweight and obesity.

  From enrollment to at least 10 years post enrollment

Study Arms (1)

Direct-to-Participant Group

Observational

Other: None - Observational study

Interventions

None - Observational study OTHER

None - Observational study

Direct-to-Participant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals currently residing in the United States

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• American Heart Association: lead
• Evidation Health: collaborator
• Duke Clinical Research Institute: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

American Heart Association

Dallas, Texas, 75231, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 20, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 1, 2060
• Study Completion (Estimated): December 1, 2060
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: July 2026 - ending 5 years after study close
• 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.

Locations

US (1)