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Completed

NCT Number: NCT02122029

Lifestyle vs.Surgery for Morbid Obesity Treatment

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.

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Key information

Conditions

Morbid Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Harokopio University

Athens, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle counselling

Behavioral

Behavioral techniques for weight management

bariatric surgery

Procedure

Vertical Banding Gastroplasty

Primary outcomes

  1. The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)

    Time frame: 9 years

Secondary outcomes

  1. Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.

    Time frame: 9 years

  2. Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.

    Time frame: 3 years

  3. Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.

    Time frame: 3 years

  4. Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.

    Time frame: 3 years

    Dietary 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).

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • The University of Texas Medical Branch, Galveston

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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