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Lifestyle vs.Surgery for Morbid Obesity Treatment

H

Harokopio University

Status and phase

Completed
Phase 3

Conditions

Morbid Obesity

Treatments

Behavioral: Lifestyle counselling
Procedure: Bariatric Surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

Female

Ages

21 to 51 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

Bariatric Surgery
Experimental group
Treatment:
Behavioral: Lifestyle counselling
Lifestyle counselling
Experimental group
Treatment:
Procedure: Bariatric Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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