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Lifestyle vs.Surgery for Morbid Obesity Treatment

A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122029
Enrollment
29
Registered
2014-04-24
Start date
2003-02-28
Completion date
2013-10-31
Last updated
2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Lifestyle intervention, Bariatric surgery, Weight management, Physical activity

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.

Interventions

Behavioral techniques for weight management

PROCEDUREBariatric Surgery

Vertical Banding Gastroplasty

Sponsors

The University of Texas Medical Branch, Galveston
CollaboratorOTHER
Harokopio University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 51 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)9 years

Secondary

MeasureTime frameDescription
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 yearsDietary intake measured as energy intake (kcal/d) derived from fat, protein and carbohydrate. Eating habits were reflected by the reported consumption of fruits, vegetables, sweets (portions/d).

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026