BODY-Q Longitudinal Result Study and Comparison With Normative Scores
NCT ID: NCT05272215
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20000 participants
OBSERVATIONAL
2015-06-30
2022-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient group
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Pre- and post body contouring surgery patients
* Fluent in Danish
Exclusion Criteria
* Patients with cognitive impairments
* Patients who have not undergone BaS/BC
18 Years
ALL
No
Sponsors
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Hospital of Southwest Jutland, Esbjerg, Denmark
UNKNOWN
McMaster University
OTHER
OLVG West Hospital, Amsterdam, the Netherlands
UNKNOWN
Catharina Ziekenhuis Eindhoven
OTHER
Tampere University Hospital
OTHER
Department of Plastic Surgery, Wroclaw, Poland
UNKNOWN
Department of Plastic Surgery, Eberhard Karls Universität Tübingen, Tübingen, Germany
OTHER
Campus Bio-Medico University
OTHER
Odense University Hospital
OTHER
Responsible Party
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Farima Dalaei
MD
Principal Investigators
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Jens A Sørensen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Lotte Poulsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Farima Dalaei, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Department of Plastic Surgery
Odense, Funen, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10240356
Identifier Type: -
Identifier Source: org_study_id
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