Weight LossNCT05272215
BODY-Q Longitudinal Result Study and Comparison With Normative Scores
An observational study of Weight Loss and Excess Skin, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Excess Skin
- What is being tested?
- Bariatric surgery and Body contouring surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish patients are recruited from June 2015 to May 2022 from four hospital departments in the Region of Southern Denmark: Department of Endocrinology, Hospital of Southwest Jutland; Department of Endocrinology, Odense University Hospital; Department of Plastic Surgery, Hospital of Southwest Jutland; and Department of Plastic Surgery, Odense University Hospital. Patients are asked to fill out the BODY-Q at following time points: before BaS, after BaS (3- ,6- ,12-months postoperative, then yearly) before BC, and after BC (3-, 6-, 12-months postoperative, then yearly). Data is collected using REDCap (Research Electronic Data Capture). The REDCap survey link and written information about the study were sent via patients' electronic secure mailbox.
Who may be able to join
- Pre- and post-bariatric surgery patients
- Pre- and post body contouring surgery patients
- Fluent in Danish
Who cannot join
- Patients who do not speak Danish
- Patients with cognitive impairments
- Patients who have not undergone BaS/BC
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery
Odense, Funen, 5000
Jens A Sørensen, MD, PhD, +4522136707, jens.sorensen@rsyd.dk
Farima Dalaei, MD, +4528823662, farima.dalaei@gmail.com
About this study
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
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.
Read the detailed 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.
- Conditions
- Weight Loss, Excess Skin
- Being tested
- Bariatric surgery, Body contouring surgery
- Keywords
- Bariatric surgery, Massive weight loss, Body contouring surgery, Health-related quality of life, Quality of life, Post bariatric surgery
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Pre- and post-bariatric surgery (3, 6, 12 months postoperative and yearly)
Body contouring surgeryProcedure or surgery
Pre- and post body contouring surgery (3, 6, 12 months postoperative and yearly)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric surgery; Procedure: Body contouring surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June 2015 to May 2022
Secondary outcomes (1)
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.
Measured: June 2015 to May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study startJun 2015
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Southwest Jutland, Esbjerg, Denmark, McMaster University, OLVG West Hospital, Amsterdam, the Netherlands, Catharina Ziekenhuis Eindhoven, Tampere University Hospital, Department of Plastic Surgery, Wroclaw, Poland, Department of Plastic Surgery, Eberhard Karls Universität Tübingen, Tübingen, Germany, Campus Bio-Medico University
- Responsible party
- Principal investigator, Farima Dalaei, Odense University Hospital
- Investigators
- Jens A Sørensen, MD, PhD, Principal investigator, Odense University HospitalLotte Poulsen, MD, PhD, Principal investigator, Odense University HospitalFarima Dalaei, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272215
- Sponsor's protocol ID
- 10240356
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available for IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05272215
- Acronym / sponsor ID
- 10240356
- Conditions
- Weight Loss, Excess Skin
- Keywords
- Bariatric surgery, Massive weight loss, Body contouring surgery, Health-related quality of life, Quality of life, Post bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Hospital of Southwest Jutland, Esbjerg, Denmark, McMaster University, OLVG West Hospital, Amsterdam, the Netherlands, Catharina Ziekenhuis Eindhoven, Tampere University Hospital, Department of Plastic Surgery, Wroclaw, Poland, Department of Plastic Surgery, Eberhard Karls Universität Tübingen, Tübingen, Germany, Campus Bio-Medico University
- Study start
- Jun 2015 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Procedure: Bariatric surgery, Procedure: Body contouring surgeryPre-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish patients are recruited from June 2015 to May 2022 from four hospital departments in the Region of Southern Denmark: Department of Endocrinology, Hospital of Southwest Jutland; Department of Endocrinology, Odense University Hospital; Department of Plastic Surgery, Hospital of Southwest Jutland; and Department of Plastic Surgery, Odense University Hospital. Patients are asked to fill out the BODY-Q at following time points: before BaS, after BaS (3- ,6- ,12-months postoperative, then yearly) before BC, and after BC (3-, 6-, 12-months postoperative, then yearly). Data is collected using REDCap (Research Electronic Data Capture). The REDCap survey link and written information about the study were sent via patients' electronic secure mailbox.
Key inclusion criteria (3 listed)
- Pre- and post-bariatric surgery patients
- Pre- and post body contouring surgery patients
- Fluent in Danish
Key exclusion criteria (3 listed)
- Patients who do not speak Danish
- Patients with cognitive impairments
- Patients who have not undergone BaS/BC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryPre- and post-bariatric surgery (3, 6, 12 months postoperative and yearly) | Procedure or surgery | Patient group |
| Body contouring surgeryPre- and post body contouring surgery (3, 6, 12 months postoperative and yearly) | Procedure or surgery | Patient group |
Primary outcome
BODY-Q Health-related quality of life (HRQL) domain
Time frame: June 2015 to May 2022
Following scales are included: 1. Appearance distress 2. Body image 3. Physical function 4. Physical symptoms 5. Psychological 6. Sexual 7. Social 8. Work life
1 secondary outcome
Comparison of patient scores to general population normative scores
Time frame: June 2015 to May 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No. No plan available for IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen, MD, PhD principal investigator
Odense University Hospital
Lotte Poulsen, MD, PhD principal investigator
Odense University Hospital
Farima Dalaei, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Excess Skin, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farima Dalaei, MD (+45 28823662, farima.dalaei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BODY-Q Health-related quality of life (HRQL) domain (time frame: June 2015 to May 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.