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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Behavioral to reduce sedentary behvaior
BehavioralThis 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 activity
BehavioralThis 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 Surgery
Procedure/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.
Treatment groups
350 Participants
are divided into 3 treatment groupsGroup A: Pre and Post InterventionExperimental treatment 3 interventions
Group B: Post InterventionExperimental treatment 3 interventions
Group C: ComparisionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical activity levels
Levels of Moderate to vigorous physical activity, light physical activity using accelerometry
Time frame
Once a year during ten years2
Sedentary behavior patterns
Number and time of Sedentary bouts and breaks using accelerometry
Time frame
Once a year during ten years3
Mass Body Index
Weight and height will be combined to report BMI in kg/m\^2
Time frame
Once a year during ten years4
Weist Circunference
Centimeters in the abdominal circunference
Time frame
Once a year during ten yearsSecondary outcomes
1
Mental Health and Wellbeing
Measured with Warwick-Edinburgh Mental Wellbeing Scales questionarie
Time frame
Once a year during ten years2
Coginitive flexibility
Measured with Impulsive Behavior Scale questionaire
Time frame
Once a year during ten yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Universitària del Bages
Lead sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: