A New Model of Exercise Referral Scheme Before and After Bariatric Surgery for People With Obesity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFundació Universitària del Bages

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Behavioral to reduce sedentary behvaior
  • Physical activity
  • Bariatric Surgery

Treatment groups

350 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Fundació Universitària del Bages

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Collaborator