Markers of excess weight, weight loss and weight regain in candidates for surgical treatment of obesity
| ISRCTN | ISRCTN59323751 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59323751 |
| Secondary identifying numbers | 8353/2011 |
- Submission date
- 29/06/2020
- Registration date
- 06/07/2020
- Last edited
- 13/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The prevalence of overweight and obesity in Portugal has increased during the last decade, following the trend that is seen globally. Bariatric surgery is an operation that helps people lose weight by making changes to their digestive system. Some recent studies have found that, following bariatric surgery, people with obesity have shown changes in food preferences. In general, these changes may suggest that there is a change in the mechanisms of food reward in the brain. However, no study to date has compared the different methods of weight loss or evaluated the changes associated with each of them. This study aims to find out whether bariatric-induced weight loss is mediated, at least in part, by modulating the effects of food reward, and whether measures of food reward are predictive of weight loss after bariatric surgery.
Who can participate?
Patients aged between 18 and 65 with obesity who are being followed in an obesity management center in which surgical alternatives are offered for the treatment of obesity. Participants may also be chosen, despite not being overweight and/or being included in any weight loss consultation, to obtain data from healthy volunteers.
What does the study involve?
This study involves completing a questionnaire assessing demographic characteristics, health information and habits. If no factors are found in this questionnaire that prevent the individual from participating in the study, volunteers will be asked to collaborate on a test session to assess taste function. An electrogustometric procedure will be carried out to measure individual taste detection threshold, as well as another test in which participants will be asked to taste several substances absorbed in filter papers. Then, participants will be asked to answer some questions about the sensations caused by each of these substances. Once these taste assessment procedures are finished, the researchers will carry out a psychometric assessment using self-report reward-related measures and questionnaires about mood, feeding behavior traits and food acceptance.
What are the possible benefits and risks of participating?
This study does not involve receiving a particular medication or treatment for a disease. The general inconveniences related to the participation result from traveling to the place where the test sessions take place and the time spent in those sessions. There are no immediate benefits from participating in this study. However, participants will be contributing to the development of scientific knowledge in this area. It is also possible that, in the longer term, the results of this study contribute to an improvement in the care provided to patients with obesity or eating disorders.
Where is the study run from?
Champalimaud Research and Clinical Centre (Portugal)
When is the study starting and how long is it expected to run for?
January 2012 to June 2017
Who is funding the study?
1. BIAL Foundation (Portugal)
2. Fundação para a Ciência e Tecnologia (Portugal)
Who is the main contact?
Prof. Albino J. Oliveira-Maia
albino.maia@neuro.fchampalimaud.org
Contact information
Scientific
Champalimaud Research & Clinical Centre
Champalimaud Centre for the Unknown
Av. de Brasília, Doca de Pedrouços
Lisbon
1400-038
Portugal
 ORCID ID |
0000-0001-5071-3007 |
|---|---|
| Phone | +351 (0)21 048 0200 |
| albino.maia@neuro.fchampalimaud.org |
Public
Champalimaud Research & Clinical Centre
Champalimaud Centre for the Unknown
Av. de Brasília, Doca de Pedrouços
Lisbon
1400-038
Portugal
| ORCID ID |
0000-0002-2232-0115 |
|---|---|
| Phone | +351 (0)21 048 0200 |
| gabriela.ribeiro@neuro.fchampalimaud.org |
Study information
| Study design | Multicenter prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Reward-related gustatory and psychometric markers of excess weight, weight loss and weight regain in candidates for surgical treatment of obesity |
| Study hypothesis | It is hypothesized that measures of food-reward sensitivity, namely sweet taste perception and self-assessed reward-related feeding behaviors, predict weight loss after bariatric surgery. Additionally the study had the following exploratory aims: 1. To test postoperative changes in these measures of food-reward sensitivity in comparison with a control group (patients on the surgery waiting list, receiving conservative treatment for obesity, including medical, nutritional and psychological support) 2. To test associations of weight loss with postoperative changes in measures of food-reward sensitivity 3. To assess differences according to surgery type in weight-loss prediction by measures of food-reward sensitivity, as well in associations between weight-loss and postoperative changes in these variables |
| Ethics approval(s) | 1. Approved 24/09/2012, Comissão de Ética - Área da Saúde Humana e Bem-Estar (Universidade de Évora. Largo dos Colegiais 2, 7000-645 Évora, Portugal; +351 (0)266 740 800; comissao.etica@uevora.pt), ref: 12031 2. Approved 22/07/2013, Comissão de Ética da Fundação Champalimaud (Fundação Champalimaud. Avenida Brasília 1400-038 Lisboa, Portugal; +351 (0)210 480 200; info@fundacaochampalimaud.pt), ref: N/A 3. Approved 05/12/2013, Comissão de Ética para a Saúde do Centro Hospitalar de São João E.P.E. (Alameda Professor Hernâni Monteiro 4200-319 Porto, Portugal; +351 (0)225 512 100; geral@hsjao.min-saude.pt), ref: CES254-13 4. Approved 06/08/2014, Conselho de Administração do Centro Hospitalar de Setúbal E.P.E. (Rua camilo castelo Branco 2910-446, Setúbal, Portugal; +351 (0)265 549 000; geral@chs.min-saude.pt), ref: 280/C.A |
| Condition | Obesity (Class II to III) |
| Intervention | This cohort will include consecutive patients with obesity at three Portuguese tertiary care outpatient centers specialized in surgical treatment of obesity. Patients will be selected according to approval for bariatric surgery, following the criteria defined in the Portuguese National Health Service. A group of patients scheduled for surgery (surgical group) will be assessed at baseline when surgery was scheduled and twice after surgery in early (up to 8 months post-surgery) and late (up to 18 months post-surgery) follow-up. A control group of patients will be recruited at admission to the bariatric surgery waiting list for baseline assessment, and re-assessed at a single follow-up, occurring within the periods defined for the surgical group, and necessarily prior to surgery, i.e., patients in the control group will not transition to the surgical group within the study. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Primary response (dependent) variable: Weight change from baseline [%WL = (weight lost/baseline weight)*100] assessed up to 18 months after surgery Main explanatory (independent) variables: 1. Mean intensity and pleasantness ratings given to four concentrations of sucrose (sweet) as assessed with general labeled magnitude scales (gLMS) at baseline up to 18 months after surgery 2. Hedonic hunger assessed with the Power of Food Scale assessed at baseline and up to 18 months after surgery 3. Addiction-like feeding behavior assessed with the Yale Food Addiction Scale assessed up to 18 months after surgery |
| Secondary outcome measures | Secondary explanatory (independent) variables: 1. Intensity and pleasantness ratings given to four concentrations of citric acid (sour) as assessed with a gLMS at baseline up to 18 months after surgery 2. Intensity and pleasantness ratings given to four concentrations of sodium chloride (salty) as assessed with a gLMS at baseline up to 18 months after surgery 3. Intensity and pleasantness ratings given to four concentrations of quinine hydrochloride (bitter) as assessed with a gLMS at baseline up to 18 months after surgery 4. Acuity in tastant identification (sour, salt, sweet and bitter) assessed in a multiple forced choice test, at baseline and up to 18 months after surgery 5. Taste thresholds assessed with electrogustometry at baseline and up to 18 months after surgery 6. Feeding behavior traits assessed by the Dutch Eating Behavior Questionnaire (DEBQ) assessed at baseline and up to 18 months after surgery 7. Food acceptance assessed by the Food Action Rating Scale (FARS) assessed at baseline and up to 18 months after surgery 8. Depressive symptom severity assessed with the Beck Depression Inventory II (BDI-II) assessed up to 18 months after surgery |
| Overall study start date | 08/01/2012 |
| Overall study end date | 07/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 212 |
| Participant inclusion criteria | Consecutive adult patients with obesity at three Portuguese tertiary care outpatient centers specialized in the surgical treatment of obesity, namely Hospital do Espírito Santo de Évora, Hospital de São Bernardo de Setúbal, and Centro Hospitalar Universitário de São João for bariatric surgery, following the criteria defined in the Portuguese National Health Service: 1. Body mass index (BMI) greater than 40 kg/m2 with or without associated comorbidities or greater than 35 Kg/m2 in the presence of at least 1 comorbidity (type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea syndrome, obese hypoventilation syndrome, arterial hypertension or osteoarticular degenerative pathology, with marked functional limitation). 2. Age between 18 and 65 years 3. Failure of non-surgical interventions for weight reduction, for at least one year, obesity that is not secondary to an identified endocrine disease 4. Ability to understand the surgical procedure and to adhere to a long-term follow-up program 5. Absence of psychiatric disorders, absence of alcohol or drug dependence 6. Balanced relationship between operative risk and clinical risk |
| Participant exclusion criteria | 1. Active acute respiratory infection 2. Active neurological or psychiatric disease 3. Active gastrointestinal, hepatic or pancreatic disease 4. Illicit substance use or alcohol abuse 5. Illiteracy or otherwise not understanding instructions for the study 6. Prior major gastrointestinal surgery 7. Intra-gastric balloon 8. History of food allergies 9. Pregnancy or breastfeeding |
| Recruitment start date | 05/11/2012 |
| Recruitment end date | 07/06/2017 |
Locations
Countries of recruitment
- Portugal
Study participating centres
Évora
7000-811
Portugal
Setúbal
2910-549
Portugal
Porto
4200–319
Portugal
Lisboa
1400-038
Portugal
Sponsor information
Research organisation
Av. de Brasília, Doca de Pedrouços
Lisbon
1400-038
Portugal
| Phone | +351 (0)210 480 048 |
|---|---|
| info@fundacaochampalimaud.pt | |
| Website | https://www.fchampalimaud.org/ |
"ROR" |
https://ror.org/05b75nt23 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bial Foundation
- Location
- Portugal
Government organisation / National government
- Alternative name(s)
- Foundation for Science and Technology, Portuguese Science and Technology Foundation, Fundacao para a Ciencia e a Tecnologia, FCT
- Location
- Portugal
Results and Publications
| Intention to publish date | 05/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Albino J. Oliveira-Maia (albino.maia@neuro.fchampalimaud.org). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 07/08/2020 | No | No | ||
| Results article | 11/03/2021 | 13/08/2021 | Yes | No |
Additional files
- ISRCTN59323751_PROTOCOL.pdf
- uploaded 07/08/2020
Editorial Notes
13/08/2021: Internal review.
20/04/2021: Publication reference added.
07/08/2020: Uploaded protocol (not peer reviewed) Version n/a.
02/07/2020: Trial's existence confirmed by Comissão de Ética - Área da Saúde Humana e Bem-Estar.
