A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Morbid Obesity
- Sponsor
- Harokopio University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.
Detailed Description
Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive. Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.
Investigators
M. Yannakoulia
Associate Professor
Harokopio University
Eligibility Criteria
Inclusion Criteria
- •female sex
- •Age ≥ 18 years
- •BMI ≥ 40 kg/m2
- •Absence of mental illness as determined by evaluation by an experienced psychiatrist
- •Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
Time Frame: 9 years
Secondary Outcomes
- Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.(9 years)
- Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.(3 years)
- Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.(3 years)
- Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.(3 years)