ObesityB-FITNCT06541977
A New Model of Exercise Referral Scheme Before and After Bariatric Surgery for People With Obesity
A study testing Behavioral to reduce sedentary behvaior, Physical activity and Bariatric Surgery in people with Obesity and Quality of Life, run by Fundació Universitària del Bages.
Trial summary
Obesity, defined by the WHO as an abnormal or excessive accumulation of fat that presents a risk to health, has reached pandemic levels, affecting approximately one-third of the world's population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Quality of Life, Weight Loss
- What is being tested?
- Behavioral to reduce sedentary behvaior, Physical activity and Bariatric Surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2025to 30 Jun 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Adults aged 18-65 years.
- BMI: Body Mass Index (BMI) ≥ 35 kg/m² with associated comorbidities (e.g., type II diabetes, hypertension) or BMI ≥ 40 kg/m² without comorbidities.
- Eligibility for Bariatric Surgery: Candidates must be approved for bariatric surgery by their healthcare provider.
- Consent: Willingness to participate in the study, including signing an informed consent form.
- Commitment: Ability to commit to the study protocol, including pre-surgery and post-surgery interventions and follow-up assessments.
- Stable Medication: Participants must be on a stable medication regimen for any existing conditions for at least three months prior to the study.
Who cannot join
- Previous Bariatric Surgery: Individuals who have undergone any form of bariatric surgery previously.
- Medical Conditions: Presence of medical conditions that contraindicate physical activity, such as severe cardiovascular disease, uncontrolled hypertension, or orthopedic conditions that limit mobility.
- Psychiatric Disorders: Severe psychiatric disorders or substance abuse issues that might impair the ability to comply with the study protocol.
- Pregnancy: Pregnant or planning to become pregnant during the study period. Participation in Other Studies: Currently participating in another clinical trial or weight loss program.
- Non-compliance Risk: Any other condition or factor that the investigators believe would prevent the participant from complying with the study protocol or that would put the participant at risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jonatan Caro, MSc contact
About this study
Official title: The Effects of a Physical Activity Program Before and After Bariatric Surgery for People With Obesity: Referral From Healthcare Settings to the B-FIT Programme.
Obesity, defined by the WHO as an abnormal or excessive accumulation of fat that presents a risk to health, has reached pandemic levels, affecting approximately one-third of the world's population. This increase spans all ages, sexes, and socioeconomic levels, though it is more prevalent in older individuals and women.
Obesity is caused by an imbalance between energy intake and expenditure, influenced by genetic, epigenetic, social, and environmental factors. Key drivers are changes in the global food system, increased sedentary behavior, and reduced physical activity.
Read more
Complications include type II diabetes, myocardial infarction, various cancers, immune system problems, and increased mortality. Obesity also results in significant economic costs, with healthcare expenses 32% higher than for people of normal weight.
Bariatric surgery is the most effective long-term treatment for severe obesity, helping reduce body weight significantly in the first years post-surgery and improving metabolic control. However, individuals often regain weight in the long term. Factors influencing this include genetics, gastrointestinal hormones, adherence to diet, and healthy behaviors like physical activity.
Sedentary behavior and physical activity are crucial for maintaining weight loss post-surgery. Physical activity increases weight loss by 4% and improves outcomes when performed before surgery. However, lack of professional support, accessibility to sports facilities, and low socioeconomic status make it difficult to sustain these behaviors with simple advice alone.
Despite this, hospital interventions often focus solely on diet, offering only advice on physical activity. Effective interventions require supervised programs of more than six months to achieve long-term behavior changes.
The B-FIT (Bariatric surgery and FITness) project aims to create a new referral and intervention model for physical activity and reducing sedentary behavior in people with obesity before and after bariatric surgery. This model seeks to prevent post-surgery weight regain and promote healthy
Read the detailed description
Obesity, as defined by the World Health Organization (WHO) as an abnormal or excessive accumulation of fat that presents a risk to health, has reached pandemic levels. Since 1980, its prevalence has doubled, affecting approximately one-third of the world's population. This increase spans all ages and both sexes, regardless of geographic location, ethnic origin, or socioeconomic level, though it is more prevalent in older individuals and women.
Obesity is a complex multifactorial disease primarily caused by an imbalance between energy intake and expenditure. Genetic, epigenetic, social, and microenvironmental factors contribute to its development. The main drivers of this pandemic are changes in the global food system, increased sedentary behavior, and reduced physical activity.
Complications and comorbidities associated with obesity include nearly all non-communicable diseases, such as type II diabetes, myocardial infarction, various types of cancer, immune system problems, and increased mortality in adulthood. Obesity also poses a significant economic cost, with 32% higher healthcare expenses compared to people of normal weight, divided into 31.8% direct costs and 68.2% indirect costs.
Currently, the most effective and cost-efficient long-term treatment for weight loss in people with obesity and comorbidities, or severe obesity, is bariatric surgery. Bariatric surgery is cost-effective, especially in the long term, helping to reduce body weight in the first years after the intervention (56.7% for gastric bypass and 45.9% for gastric balloon in the first ten years), improving metabolic control, and reducing obesity-related comorbidities.
However, individuals undergoing gastric bypass or gastric balloon surgery tend to regain weight in the long term. At least one in six operated individuals regain weight, and by 24 months post-surgery, up to 50% of patients regain weight. Factors such as genetics, anatomy, gastrointestinal hormones, adherence to a balanced diet, and healthy behaviors (reducing sedentary behavior and increasing physical activity) influence weight regain after bariatric surgery.
Sedentary behavior and physical activity are crucial for maintaining weight loss post-bariatric surgery. Physical activity post-surgery increases weight loss by 4%, and when performed before the intervention, improves weight loss at 12 months follow-up. However, the predisposition to obesity and weight regain post-surgery is influenced by factors such as lack of professional support, accessibility to sports facilities, and low socioeconomic status, making it difficult to improve physical activity levels and reduce sedentary behavior with simple health advice.
Despite this knowledge, hospital interventions before and after bariatric surgery focus on improving diet and only offer advice on physical activity, never physical activity and health behavior change interventions. Although diet is crucial and these interventions are often sufficient, physical activity and reducing sedentary behavior require supervised interventions of more than six months to achieve long-term behavior changes.
For these reasons, it is important to study through randomized clinical trials, with long-term follow-up, the effects of physical activity and reducing sedentary behavior on weight control, metabolic outcomes, and the quality of life, both mental and physical, of people with obesity who are going to undergo or have undergone bariatric surgery.
The B-FIT (Bariatric surgery and FITness) project aims to create a new referral and intervention model, from Hospital Sant Joan de Déu (Fundación Althaia) to the University of Vic-Central University of Catalonia, for physical activity and reducing sedentary behavior in people with obesity, both before and after bariatric surgery. This model aims to prevent post-surgery weight regain and promote healthy habits through behavior change techniques and supervised physical activity.
- Conditions
- Obesity, Quality of Life, Weight Loss
- Being tested
- Behavioral to reduce sedentary behvaior, Physical activity, Bariatric Surgery
- Keywords
- bariatric surgery, physical activity, quality of life, obesity
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral to reduce sedentary behvaiorBehavioural
This intervention will also utilize a geographical time app to raise awareness about participants' sedentary lifestyles, helping them identify opportunities to incorporate more movement into their daily routines. Furthermore, the program will implement the Wheel of Change behavior technique, which serves as a structured approach to facilitate lasting changes in health behaviors, empowering participants to take control of their physical activity levels and overall well-being.
Physical activityBehavioural
This intervention will be conducted with two weekly days of supervised and structured physical activity sessions, held at the university's facilities, providing participants with expert guidance and a supportive environment to enhance their physical fitness and overall health.
Bariatric SurgeryProcedure or surgery
In this intervention, bariatric surgery will be performed, accompanied by the usual hospital care, which includes comprehensive nutritional and physical activity advice. This standard care ensures that participants receive essential guidance and support for their dietary and exercise routines, complementing the surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pre and Post Intervention | Experimental | Participants in this group will receive the usual hospital care, which includes psychology visits, nutritional advice, and a physical activity protocol plan. In addition, participants will be referral form the Hospital to the Unviersity to undertake supervised physical activity sessions and health behavior change techniques aimed at reducing sedentary behavior and improving quality of life. This intervention will start 8 months before surgery and continue for 12 months post-surgery, with regular monitoring and support to sustain life-changing behaviors. Receives: Behavioral: Behavioral to reduce sedentary behvaior; Behavioral: Physical activity; Procedure: Bariatric Surgery |
| Post Intervention | Experimental | Participants in this group will receive the usual hospital care, including psychology visits, nutritional advice, and a physical activity protocol plan. Additionally, participants in this group will be referral from the Hospital to the Unviersity to begin supervised physical activity sessions and health behavior change techniques 12 months post-surgery, designed to reduce sedentary behavior and improve quality of life, with continuous professional support throughout the intervention period. Receives: Behavioral: Behavioral to reduce sedentary behvaior; Behavioral: Physical activity; Procedure: Bariatric Surgery |
| Comparision | Active comparator | Participants in this group will receive the usual hospital care, which includes psychology visits, nutritional advice, and a physical activity protocol plan provided on a sheet. There will be no additional supervised physical activity sessions or health behavior change techniques beyond the standard care currently provided by the hospital. Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity levels
Levels of Moderate to vigorous physical activity, light physical activity using accelerometry
Measured: Once a year during ten years
Sedentary behavior patterns
Number and time of Sedentary bouts and breaks using accelerometry
Measured: Once a year during ten years
Mass Body Index
Weight and height will be combined to report BMI in kg/m^2
Measured: Once a year during ten years
Weist Circunference
Centimeters in the abdominal circunference
Measured: Once a year during ten years
Secondary outcomes (2)
Mental Health and Wellbeing
Measured with Warwick-Edinburgh Mental Wellbeing Scales questionarie
Measured: Once a year during ten years
Coginitive flexibility
Measured with Impulsive Behavior Scale questionaire
Measured: Once a year during ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start9 Sep 2025 (estimated)
- Primary completion2 May 2026 (estimated)
- Study completion30 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Groups will be followed and assessed concurrently but separately, ensuring that the comparison between interventions is clear and not influenced by crossover effects.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Universitària del Bages
- Sponsor type
- University, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa
- Responsible party
- Sponsor
- Investigators
- Guillem Jabardo Camprubí, PhD, Principal investigator, Faculty of Health Science at Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541977
- Sponsor's protocol ID
- UManresa_B-FIT2024
- Acronym
- B-FIT
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
PubMed 30253139Baillot A, Vallee CA, Mampuya WM, Dionne IJ, Comeau E, Meziat-Burdin A, Langlois MF. Effects of a Pre-surgery Supervised Exercise Training 1 Year After Bariatric Surgery: a Randomized Controlled Study. Obes Surg. 2018 Apr;28(4):955-962. doi: 10.1007/s11695-017-2943-8.
PubMed 28963710Lier HO, Biringer E, Stubhaug B, Tangen T. The impact of preoperative counseling on postoperative treatment adherence in bariatric surgery patients: a randomized controlled trial. Patient Educ Couns. 2012 Jun;87(3):336-42. doi: 10.1016/j.pec.2011.09.014. Epub 2011 Oct 27.
PubMed 22035647
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Physical Activity Program Before and After Bariatric Surgery for People With Obesity: Referral From Healthcare Settings to the B-FIT Programme.
- ClinicalTrials.gov ID
- NCT06541977
- Acronym / sponsor ID
- B-FIT / UManresa_B-FIT2024
- Conditions
- Obesity, Quality of Life, Weight Loss
- Keywords
- bariatric surgery, physical activity, quality of life, obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Fundació Universitària del BagesUniversity, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa
- Study start
- 9 Sep 2025 (estimated)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 30 Jun 2036 (estimated)
- First posted
- 7 Aug 2024 (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, defined by the WHO as an abnormal or excessive accumulation of fat that presents a risk to health, has reached pandemic levels, affecting approximately one-third of the world's population. This increase spans all ages, sexes, and socioeconomic levels, though it is more prevalent in older individuals and women.
Obesity is caused by an imbalance between energy intake and expenditure, influenced by genetic, epigenetic, social, and environmental factors. Key drivers are changes in the global food system, increased sedentary behavior, and reduced physical activity.
Complications include type II diabetes, myocardial infarction, various cancers, immune system problems, and increased mortality. Obesity also results in significant economic costs, with healthcare expenses 32% higher than for people of normal weight.
Bariatric surgery is the most effective long-term treatment for severe obesity, helping reduce body weight significantly in the first years post-surgery and improving metabolic control. However, individuals often regain weight in the long term. Factors influencing this include genetics, gastrointestinal hormones, adherence to diet, and healthy behaviors like physical activity.
Sedentary behavior and physical activity are crucial for maintaining weight loss post-surgery. Physical activity increases weight loss by 4% and improves outcomes when performed before surgery. However, lack of professional support, accessibility to sports facilities, and low socioeconomic status make it difficult to sustain these behaviors with simple advice alone.
Despite this, hospital interventions often focus solely on diet, offering only advice on physical activity. Effective interventions require supervised programs of more than six months to achieve long-term behavior changes.
The B-FIT (Bariatric surgery and FITness) project aims to create a new referral and intervention model for physical activity and reducing sedentary behavior in people with obesity before and after bariatric surgery. This model seeks to prevent post-surgery weight regain and promote healthy
Detailed description
Obesity, as defined by the World Health Organization (WHO) as an abnormal or excessive accumulation of fat that presents a risk to health, has reached pandemic levels. Since 1980, its prevalence has doubled, affecting approximately one-third of the world's population. This increase spans all ages and both sexes, regardless of geographic location, ethnic origin, or socioeconomic level, though it is more prevalent in older individuals and women.
Obesity is a complex multifactorial disease primarily caused by an imbalance between energy intake and expenditure. Genetic, epigenetic, social, and microenvironmental factors contribute to its development. The main drivers of this pandemic are changes in the global food system, increased sedentary behavior, and reduced physical activity.
Complications and comorbidities associated with obesity include nearly all non-communicable diseases, such as type II diabetes, myocardial infarction, various types of cancer, immune system problems, and increased mortality in adulthood. Obesity also poses a significant economic cost, with 32% higher healthcare expenses compared to people of normal weight, divided into 31.8% direct costs and 68.2% indirect costs.
Currently, the most effective and cost-efficient long-term treatment for weight loss in people with obesity and comorbidities, or severe obesity, is bariatric surgery. Bariatric surgery is cost-effective, especially in the long term, helping to reduce body weight in the first years after the intervention (56.7% for gastric bypass and 45.9% for gastric balloon in the first ten years), improving metabolic control, and reducing obesity-related comorbidities.
However, individuals undergoing gastric bypass or gastric balloon surgery tend to regain weight in the long term. At least one in six operated individuals regain weight, and by 24 months post-surgery, up to 50% of patients regain weight. Factors such as genetics, anatomy, gastrointestinal hormones, adherence to a balanced diet, and healthy behaviors (reducing sedentary behavior and increasing physical activity) influence weight regain after bariatric surgery.
Sedentary behavior and physical activity are crucial for maintaining weight loss post-bariatric surgery. Physical activity post-surgery increases weight loss by 4%, and when performed before the intervention, improves weight loss at 12 months follow-up. However, the predisposition to obesity and weight regain post-surgery is influenced by factors such as lack of professional support, accessibility to sports facilities, and low socioeconomic status, making it difficult to improve physical activity levels and reduce sedentary behavior with simple health advice.
Despite this knowledge, hospital interventions before and after bariatric surgery focus on improving diet and only offer advice on physical activity, never physical activity and health behavior change interventions. Although diet is crucial and these interventions are often sufficient, physical activity and reducing sedentary behavior require supervised interventions of more than six months to achieve long-term behavior changes.
For these reasons, it is important to study through randomized clinical trials, with long-term follow-up, the effects of physical activity and reducing sedentary behavior on weight control, metabolic outcomes, and the quality of life, both mental and physical, of people with obesity who are going to undergo or have undergone bariatric surgery.
The B-FIT (Bariatric surgery and FITness) project aims to create a new referral and intervention model, from Hospital Sant Joan de Déu (Fundación Althaia) to the University of Vic-Central University of Catalonia, for physical activity and reducing sedentary behavior in people with obesity, both before and after bariatric surgery. This model aims to prevent post-surgery weight regain and promote healthy habits through behavior change techniques and supervised physical activity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Groups will be followed and assessed concurrently but separately, ensuring that the comparison between interventions is clear and not influenced by crossover effects.
| Arm | Type | Receives |
|---|---|---|
| Pre and Post Intervention | Experimental | Behavioral: Behavioral to reduce sedentary behvaior, Behavioral: Physical activity, Procedure: Bariatric SurgeryParticipants in this group will receive the usual hospital care, which includes psychology visits, nutritional advice, and a physical activity protocol plan. In addition, participants will be referral form the Hospital to the Unviersity to undertake supervised physical activity sessions and health behavior change techniques aimed at reducing sedentary behavior and improving quality of life. This intervention will start 8 months before surgery and continue for 12 months post-surgery, with regular monitoring and support to sustain life-changing behaviors. |
| Post Intervention | Experimental | Behavioral: Behavioral to reduce sedentary behvaior, Behavioral: Physical activity, Procedure: Bariatric SurgeryParticipants in this group will receive the usual hospital care, including psychology visits, nutritional advice, and a physical activity protocol plan. Additionally, participants in this group will be referral from the Hospital to the Unviersity to begin supervised physical activity sessions and health behavior change techniques 12 months post-surgery, designed to reduce sedentary behavior and improve quality of life, with continuous professional support throughout the intervention period. |
| Comparision | Active comparator | Procedure: Bariatric SurgeryParticipants in this group will receive the usual hospital care, which includes psychology visits, nutritional advice, and a physical activity protocol plan provided on a sheet. There will be no additional supervised physical activity sessions or health behavior change techniques beyond the standard care currently provided by the hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Adults aged 18-65 years.
- BMI: Body Mass Index (BMI) ≥ 35 kg/m² with associated comorbidities (e.g., type II diabetes, hypertension) or BMI ≥ 40 kg/m² without comorbidities.
- Eligibility for Bariatric Surgery: Candidates must be approved for bariatric surgery by their healthcare provider.
- Consent: Willingness to participate in the study, including signing an informed consent form.
- Commitment: Ability to commit to the study protocol, including pre-surgery and post-surgery interventions and follow-up assessments.
Key exclusion criteria (5 listed)
- Previous Bariatric Surgery: Individuals who have undergone any form of bariatric surgery previously.
- Medical Conditions: Presence of medical conditions that contraindicate physical activity, such as severe cardiovascular disease, uncontrolled hypertension, or orthopedic conditions that limit mobility.
- Psychiatric Disorders: Severe psychiatric disorders or substance abuse issues that might impair the ability to comply with the study protocol.
- Pregnancy: Pregnant or planning to become pregnant during the study period. Participation in Other Studies: Currently participating in another clinical trial or weight loss program.
- Non-compliance Risk: Any other condition or factor that the investigators believe would prevent the participant from complying with the study protocol or that would put the participant at risk.
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 |
|---|---|---|
| Behavioral to reduce sedentary behvaiorThis intervention will also utilize a geographical time app to raise awareness about participants' sedentary lifestyles, helping them identify opportunities to incorporate more movement into their daily routines. Furthermore, the program will implement the Wheel of Change behavior technique, which serves as a structured approach to facilitate lasting changes in health behaviors, empowering participants to take control of their physical activity levels and overall well-being. | Behavioural | Post Intervention, Pre and Post Intervention |
| Physical activityThis intervention will be conducted with two weekly days of supervised and structured physical activity sessions, held at the university's facilities, providing participants with expert guidance and a supportive environment to enhance their physical fitness and overall health. | Behavioural | Post Intervention, Pre and Post Intervention |
| Bariatric SurgeryIn this intervention, bariatric surgery will be performed, accompanied by the usual hospital care, which includes comprehensive nutritional and physical activity advice. This standard care ensures that participants receive essential guidance and support for their dietary and exercise routines, complementing the surgical intervention. | Procedure or surgery | Comparision, Post Intervention, Pre and Post Intervention |
Primary outcome
Physical activity levels
Time frame: Once a year during ten years
Levels of Moderate to vigorous physical activity, light physical activity using accelerometry
Sedentary behavior patterns
Time frame: Once a year during ten years
Number and time of Sedentary bouts and breaks using accelerometry
Mass Body Index
Time frame: Once a year during ten years
Weight and height will be combined to report BMI in kg/m^2
Weist Circunference
Time frame: Once a year during ten years
Centimeters in the abdominal circunference
2 secondary outcomes
Mental Health and Wellbeing
Time frame: Once a year during ten years
Coginitive flexibility
Time frame: Once a year during ten years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 30253139Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
- Background: PubMed 28963710Baillot A, Vallee CA, Mampuya WM, Dionne IJ, Comeau E, Meziat-Burdin A, Langlois MF. Effects of a Pre-surgery Supervised Exercise Training 1 Year After Bariatric Surgery: a Randomized Controlled Study. Obes Surg. 2018 Apr;28(4):955-962. doi: 10.1007/s11695-017-2943-8.
- Background: PubMed 22035647Lier HO, Biringer E, Stubhaug B, Tangen T. The impact of preoperative counseling on postoperative treatment adherence in bariatric surgery patients: a randomized controlled trial. Patient Educ Couns. 2012 Jun;87(3):336-42. doi: 10.1016/j.pec.2011.09.014. Epub 2011 Oct 27.
- Individual participant dataSharing planned: No
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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.
Jonatan Caro, MSc contact
Guillem Jabardo Camprubí, PhD principal investigator
Faculty of Health Science at Manresa
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral to reduce sedentary behvaior, Physical activity and Bariatric Surgery in people with Obesity and Quality of Life, run by Fundació Universitària del Bages.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillem Jabardo Camprubí, PhD (691145828, gjabardo@umanresa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels (time frame: Once a year during ten years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06541977, which also lists 3 linked publications.
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 7 Aug 2024.