Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541977
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A New Model of Exercise Referral Scheme Before and After Bariatric Surgery for People With Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-FIT
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 worlds 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
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
Detailed Description:
Obesity as defined by the World Health Organization WHO as an abnormal or excessive accumulation of fat that presents a risk to health has reached pandemic levels Since 1980 its prevalence has doubled affecting approximately one-third of the worlds population This increase spans all ages and both sexes regardless of geographic location ethnic origin or socioeconomic level though it is more prevalent in older individuals and women
Obesity is a complex multifactorial disease primarily caused by an imbalance between energy intake and expenditure Genetic epigenetic social and microenvironmental factors contribute to its development The main drivers of this pandemic are changes in the global food system increased sedentary behavior and reduced physical activity
Complications and comorbidities associated with obesity include nearly all non-communicable diseases such as type II diabetes myocardial infarction various types of cancer immune system problems and increased mortality in adulthood Obesity also poses a significant economic cost with 32 higher healthcare expenses compared to people of normal weight divided into 318 direct costs and 682 indirect costs
Currently the most effective and cost-efficient long-term treatment for weight loss in people with obesity and comorbidities or severe obesity is bariatric surgery Bariatric surgery is cost-effective especially in the long term helping to reduce body weight in the first years after the intervention 567 for gastric bypass and 459 for gastric balloon in the first ten years improving metabolic control and reducing obesity-related comorbidities
However individuals undergoing gastric bypass or gastric balloon surgery tend to regain weight in the long term At least one in six operated individuals regain weight and by 24 months post-surgery up to 50 of patients regain weight Factors such as genetics anatomy gastrointestinal hormones adherence to a balanced diet and healthy behaviors reducing sedentary behavior and increasing physical activity influence weight regain after bariatric surgery
Sedentary behavior and physical activity are crucial for maintaining weight loss post-bariatric surgery Physical activity post-surgery increases weight loss by 4 and when performed before the intervention improves weight loss at 12 months follow-up However the predisposition to obesity and weight regain post-surgery is influenced by factors such as lack of professional support accessibility to sports facilities and low socioeconomic status making it difficult to improve physical activity levels and reduce sedentary behavior with simple health advice
Despite this knowledge hospital interventions before and after bariatric surgery focus on improving diet and only offer advice on physical activity never physical activity and health behavior change interventions Although diet is crucial and these interventions are often sufficient physical activity and reducing sedentary behavior require supervised interventions of more than six months to achieve long-term behavior changes
For these reasons it is important to study through randomized clinical trials with long-term follow-up the effects of physical activity and reducing sedentary behavior on weight control metabolic outcomes and the quality of life both mental and physical of people with obesity who are going to undergo or have undergone bariatric surgery
The B-FIT Bariatric surgery and FITness project aims to create a new referral and intervention model from Hospital Sant Joan de Déu Fundación Althaia to the University of Vic-Central University of Catalonia for physical activity and reducing sedentary behavior in people with obesity both before and after bariatric surgery This model aims to prevent post-surgery weight regain and promote healthy habits through behavior change techniques and supervised physical activity
Obesity is a complex multifactorial disease primarily caused by an imbalance between energy intake and expenditure Genetic epigenetic social and microenvironmental factors contribute to its development The main drivers of this pandemic are changes in the global food system increased sedentary behavior and reduced physical activity
Complications and comorbidities associated with obesity include nearly all non-communicable diseases such as type II diabetes myocardial infarction various types of cancer immune system problems and increased mortality in adulthood Obesity also poses a significant economic cost with 32 higher healthcare expenses compared to people of normal weight divided into 318 direct costs and 682 indirect costs
Currently the most effective and cost-efficient long-term treatment for weight loss in people with obesity and comorbidities or severe obesity is bariatric surgery Bariatric surgery is cost-effective especially in the long term helping to reduce body weight in the first years after the intervention 567 for gastric bypass and 459 for gastric balloon in the first ten years improving metabolic control and reducing obesity-related comorbidities
However individuals undergoing gastric bypass or gastric balloon surgery tend to regain weight in the long term At least one in six operated individuals regain weight and by 24 months post-surgery up to 50 of patients regain weight Factors such as genetics anatomy gastrointestinal hormones adherence to a balanced diet and healthy behaviors reducing sedentary behavior and increasing physical activity influence weight regain after bariatric surgery
Sedentary behavior and physical activity are crucial for maintaining weight loss post-bariatric surgery Physical activity post-surgery increases weight loss by 4 and when performed before the intervention improves weight loss at 12 months follow-up However the predisposition to obesity and weight regain post-surgery is influenced by factors such as lack of professional support accessibility to sports facilities and low socioeconomic status making it difficult to improve physical activity levels and reduce sedentary behavior with simple health advice
Despite this knowledge hospital interventions before and after bariatric surgery focus on improving diet and only offer advice on physical activity never physical activity and health behavior change interventions Although diet is crucial and these interventions are often sufficient physical activity and reducing sedentary behavior require supervised interventions of more than six months to achieve long-term behavior changes
For these reasons it is important to study through randomized clinical trials with long-term follow-up the effects of physical activity and reducing sedentary behavior on weight control metabolic outcomes and the quality of life both mental and physical of people with obesity who are going to undergo or have undergone bariatric surgery
The B-FIT Bariatric surgery and FITness project aims to create a new referral and intervention model from Hospital Sant Joan de Déu Fundación Althaia to the University of Vic-Central University of Catalonia for physical activity and reducing sedentary behavior in people with obesity both before and after bariatric surgery This model aims to prevent post-surgery weight regain and promote healthy habits through behavior change techniques and supervised physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None