NCT06541977Not yet recruiting
A New Model of Exercise Referral Scheme Before and After Bariatric Surgery for People With Obesity
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.
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 9 Sept 2025
- Primary completion date
- 2 May 2026
- Lead sponsor
- Fundació Universitària del Bages
- Diseases
- Obesity
- NCT number
- NCT06541977
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 9 Sept 2025 to the primary completion date, 2 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Bariatric Surgery: Individuals who have undergone any form of bariatric surgery previously.
Other illness
- 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.
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.