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

NCT06541977 | Not Yet Recruiting DMC

• 1 other identifier: UManresa_B-FIT2024
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obesity; Quality of Life; Weight Loss

Keywords

bariatric surgery; physical activity; quality of life; obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mental Health and Wellbeing

  Once a year during ten years

• Coginitive flexibility

  Once a year during ten years

Study Arms (3)

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.

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.

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.

Procedure: Bariatric Surgery

Interventions

Behavioral to reduce sedentary behvaior BEHAVIORAL

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.

Post Intervention; Pre and Post Intervention

Physical activity BEHAVIORAL

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.

Post Intervention; Pre and Post Intervention

Bariatric Surgery PROCEDURE

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.

Comparision; Post Intervention; Pre and Post Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Universitària del Bages: lead
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator

Related Publications (3)

• 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.

  PMID: 30253139 BACKGROUND

• Baillot 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.

  PMID: 28963710 BACKGROUND

• Lier 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.

  PMID: 22035647 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Interventions

Exercise; Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Guillem Jabardo Camprubí, PhD

  Faculty of Health Science at Manresa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillem Jabardo Camprubí, PhD

CONTACT

691145828; gjabardo@umanresa.cat

Jonatan Caro, MSc

CONTACT

jcaro@umanresa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups will be followed and assessed concurrently but separately, ensuring that the comparison between interventions is clear and not influenced by crossover effects.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: September 9, 2025
• Primary Completion: May 2, 2026
• Study Completion (Estimated): June 30, 2036
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share