A New Model of Exercise Referral Scheme Before and After Bariatric Surgery for People With Obesity
NCT Number: NCT06541977
Acronym: B-FIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Quality of Life|Weight Loss
Interventions: BEHAVIORAL: Behavioral to reduce sedentary behvaior|BEHAVIORAL: Physical activity|PROCEDURE: Bariatric Surgery
Sponsor: Fundació Universitària del Bages
Collaborators: Althaia Xarxa Assistencial Universitària de Manresa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-09-09
Completion Date: 2036-06-30

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. 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

Primary Outcome Measures: Physical activity levels, Levels of Moderate to vigorous physical activity, light physical activity using accelerometry, Once a year during ten years|Sedentary behavior patterns, Number and time of Sedentary bouts and breaks using accelerometry, Once a year during ten years|Mass Body Index, Weight and height will be combined to report BMI in kg/m\^2, Once a year during ten years|Weist Circunference, Centimeters in the abdominal circunference, Once a year during ten years
Secondary Outcome Measures: Mental Health and Wellbeing, Measured with Warwick-Edinburgh Mental Wellbeing Scales questionarie, Once a year during ten years|Coginitive flexibility, Measured with Impulsive Behavior Scale questionaire, Once a year during ten years