BODY-Q Longitudinal Result Study and Comparison With Normative Scores

Odense University Hospital

Status: Unknown

Conditions: Weight Loss; Excess Skin

Treatments: Procedure: Body contouring surgery; Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05272215

10240356

Details and patient eligibility

About

Obesity is a global epidemic that has nearly tripled since 1975. Worldwide, over 650 million people live with obesity, and it is therefore a growing cause for concern. Bariatric surgery (BaS) is the most effective long-term weight loss method in morbidly obese patients. BaS can result in sustained weight loss and resolve obesity-related comorbidities. However, BaS most often results in various extremes of excess skin, where subsequent body contouring surgery (BC) can be needed. The excess skin following massive weight loss is known to negatively impacts patients' body image, physical and psychological well-being, which previous studies have indicated to improve after BC.

The purpose of this study is to assess change in patients' health-related quality of life (HRQL) relative to the general population score. To the best of our knowledge, there are no studies measuring change of patient's HRQL throughout the entire weight loss journey and comparing these scores with the scores of the general population.

It is hypothesized that 1) BaS will improve patients' quality of life on short terms (1-2 years) after surgery, however patients' HRQL will decrease with increasing amounts of excess skin. 2) Patients' HRQL will improve after post-BC equivalent of the scores of the general population.

Full description

HRQL is best measured through patient-reported outcomes (PRO), defined as a patient evaluation of outcomes without interference from clinicians or any other intermediary. A vast array of patient-reported outcome measure (PROM)s have been used in weight loss and BC patients, many of which do not possess strong evidence of reliability and validity for the patient population.

In 2016, The BODY-Q, a condition-specific PROM developed following internationally recommended guidelines to measure PRO in weight loss, including bariatric surgery, and body contouring surgery (BC) patients were introduced. It consists of 32 independently functioning scales measuring four domains: appearance, HRQL, eating-related concerns, and patient experience of care. It is rigorously tested to ensure content validity, reliability, and responsiveness. Due to the strongest evidence for validity and its psychometric properties, recent systematic review based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology only recommend the BODY-Q for use in this patient population.

The BODY-Q has been shown to be responsive to change and subsequently to measure change over the entire weight loss trajectory, i.e., from obesity to weight loss with or without BC. In previous studies, the BODY-Q has been used to demonstrate the efficacy of weight loss therapy and BC.

However, a current limitation of the BODY-Q is the lack of general population norms as a reference value of the four domains (HRQL, appearance, eating-related concerns, and experience of care). To date, it is not known how published preoperative and postoperative scores compare to population norms, enabling a better understanding of HRQL of obesity and change through the weight loss trajectory.

The primary aim of this study is to investigate the change of HRQL through the entire weight loss journey from obesity to post-BC in a longitudinal, prospective cohort study of Danish patients. The study will be performed as part of an international collaboration and Danish data will be merged with data from the Netherlands, Finland, Poland, Italy, Germany, and the United States. The secondary aim of this study is to compare international patient results with the general population norms. The general population norms. Currently, the general population norms study is under submission.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre- and post-bariatric surgery patients
• Pre- and post body contouring surgery patients
• Fluent in Danish

Exclusion criteria

• Patients who do not speak Danish
• Patients with cognitive impairments
• Patients who have not undergone BaS/BC

Trial design

20,000 participants in 1 patient group

Patient group

Description:

Pre-BaS: Patients administered for BaS, Department of Endocrinology either Odense University Hospital, Odense, Denmark or Hospital of Southwest Jutland, Esbjerg, Denmark Post-BaS: (3, 6, 12 months postoperatively, then yearly) Department of Surgery, Southwest Jutland, Esbjerg, Denmark Pre-BC: Patients administered for BC, Department of Plastic Surgery, Odense University Hospital, Odense, Denmark or Department of Plastic Surgery, Southwest Jutland, Esbjerg, Denmark. Post-BC: (3, 6, 12 months postoperatively, then yearly), department of Plastic Surgery, Odense University Hospital; Hospital of Southwest Jutland, Esbjerg. Normative group: Reference scores of the general population from an international sample of 10 countries and country specific scores. This study sample is submitted for publication elsewhere.

Treatment:

Procedure: Body contouring surgery

Procedure: Bariatric surgery