Healthy Living BEYOND Weight Study

Overview

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.

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.

Interventions

• Other None - Observational study
  None - Observational study

Primary outcome measures

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• American Heart Association — Dallas

Identifiers

NCT: NCT07075341 · Pro00086052

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗