BODY-Q Longitudinal Result Study and Comparison With Normative Scores

Weight Loss Clinical Trial

Official title:

Longitudinal Follow-up and Comparison of Bariatric and Post-bariatric Body Contouring Patient's Health-related Quality of Life Relative to Population Norms Using the BODY-Q

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272215
• Other study ID #: 10240356
• Status: Recruiting
• Start date: June 2015
• Est. completion date: May 2022

Study information

• Verified date: February 2022
• Source: Odense University Hospital
• Contact: Farima Dalaei, MD
• Phone: +45 28823662
• Email: farima.dalaei[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

Procedure:
• Bariatric surgery
Pre- and post-bariatric surgery (3, 6, 12 months postoperative and yearly)
• Body contouring surgery
Pre- and post body contouring surgery (3, 6, 12 months postoperative and yearly)

Locations

Country	Name	City	State
Denmark	Department of Plastic Surgery	Odense	Funen

Sponsors (9)

Lead Sponsor	Collaborator
Odense University Hospital	Campus Bio-Medico University, Catharina Ziekenhuis Eindhoven, Department of Plastic Surgery, Eberhard Karls Universität Tübingen, Tübingen, Germany, Department of Plastic Surgery, Wroclaw, Poland, Hospital of Southwest Jutland, Esbjerg, Denmark, McMaster University, OLVG West Hospital, Amsterdam, the Netherlands, Tampere University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BODY-Q Health-related quality of life (HRQL) domain	Following scales are included: Appearance distress; Body image; Physical function; Physical symptoms; Psychological; Sexual; Social; Work life	June 2015 to May 2022
Secondary	Comparison of patient scores to general population normative scores	The scores of patients will be compared to the general population normative scores to assess the impact of BaS and BC on patients' lives compared to the general population HRQL.	June 2015 to May 2022