Randomised Trial of Intensive Behavioral Lifestyle Intervention Versus Usual Preparation for Bariatric Surgery

NCT04282304 | Terminated

• 1 other identifier: 19-006
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized clinical trial aiming to compare a comprehensive, intensive behavioral lifestyle intervention and usual care during the preoperative preparation to bariatric surgery, with primary outcome on excess weight loss and secondary outcomes on patient's physical status, quality of life, comorbidity and technical difficulty of the surgery.

Conditions

Morbid Obesity

Keywords

Behavioral intervention; Severe obesity; Weight loss; Bariatric surgery

Outcome Measures

Primary Outcomes (3)

• Changes in body weight

  Changes in body weight

  Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

• Excess weight loss

  The percentage of excess weight loss is obtained as follow: (initial body weight - body weight at 2 years postoperatively) / (initial body weight - ideal body weight at BMI 25) x 100

  2 years after surgery

• Changes in Body Mass Index (BMI)

  Changes in Body Mass Index, obtained as follow: body weight (in kilograms)/ the square of height (in meters)

  Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

Secondary Outcomes (17)

• Changes in the physical status in terms of muscle/fat report

  Before preparation, before surgery and 24 months after surgery

• Changes in the physical status in terms of walking abilities

  before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

• Changes in the physical status in terms of waist circumference

  before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

• Changes in physical status in terms of hip circumference

  before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

• Changes in surgical difficulty in terms of left liver volume

  Before preparation, before surgery and 24 months after surgery

Study Arms (2)

Usual Care

OTHER

The patients in this arm will have usual care during preoperative period, bariatric surgery and follow-up.

Behavioral: Preoperative usual care

UGECAM

EXPERIMENTAL

During the preoperative period, the patients in this arm will have usual care and a 4 weeks intensive, comprehensive behavioral lifestyle intervention. They will then have usual bariatric surgery and follow-up.

Behavioral: Preoperative intensive behavioral lifestyle intervention

Interventions

Preoperative usual care BEHAVIORAL

Usual care during the preoperative preparation for bariatric surgery consists of: * Endocrinologist work-up and follow-up, with at least 2 consultations; * Dietary advice, provided during the endocrine consultation or dietician consultation * Psychological counselling with the patient's usual psychiatrist (at least 2 consultations * Physical activity and nutrition are encouraged, but entrusted to the patient's freedom of choice. Weight loss, or at least, weight stabilization, is recommended before the surgery, without initiating a specific behavioural procedure.

Usual Care

Preoperative intensive behavioral lifestyle intervention BEHAVIORAL

The intensive behavioral lifestyle intervention program takes place over 4 weeks of 5 days. It includes: * Rehabilitation to physical exercise every morning * Therapeutic cooking sessions; during these sessions, the patients prepare the day's meals under the supervision of a nutritionist * Psychological counselling * One swimming session per week * One relaxation session * Regular physical activity (aerobics, work-up) * Individual entertainment with the physiotherapist physician and discussion groups * Weight, BMI and waist circumference control at the end of each week.

UGECAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who desires obesity surgery
• Patient agreeing to participate in the study, including the 2 years follow-up
• Patient accepting the constraints of the study related to the group to which he/she will be assigned as a result of randomization (availability to his work, his family, etc.)
• Patient able to receive and to understand the study information and to give written informed consent
• Patient affiliated with the French social security system

You may not qualify if:

• Patient with a BMI of more than 60
• Patient with contraindication to laparoscopic obesity surgery
• Patient already operated on for obesity
• Patient with a history of major abdominal surgery
• Patient with contraindications to MRI:
• pace maker or automatic defibrillator, implanted insulin pump
• auditory neurostimulator, anal neurostimulator, etc.
• ferromagnetic bodies in soft tissues, intraocular foreign bodies, cerebral vascular clips
• claustrophobia
• morphotype not allowing access to MRI: morbid obesity with waist circumference greater than 150 cm, shoulder width greater than 59 cm
• Patient with psychiatric pathology (untreated psychosis, drug dependence, etc.)
• Pregnant or breast-feeding patient
• Patient under safeguard of justice
• Patient under guardianship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

Location

Related Publications (5)

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.

  PMID: 24239920 BACKGROUND

• Yang YX, Chong MS, Lim WS, Tay L, Yew S, Yeo A, Tan CH. Validity of estimating muscle and fat volume from a single MRI section in older adults with sarcopenia and sarcopenic obesity. Clin Radiol. 2017 May;72(5):427.e9-427.e14. doi: 10.1016/j.crad.2016.12.011. Epub 2017 Jan 20.

  PMID: 28117037 BACKGROUND

• Maislin G, Ahmed MM, Gooneratne N, Thorne-Fitzgerald M, Kim C, Teff K, Arnardottir ES, Benediktsdottir B, Einarsdottir H, Juliusson S, Pack AI, Gislason T, Schwab RJ. Single slice vs. volumetric MR assessment of visceral adipose tissue: reliability and validity among the overweight and obese. Obesity (Silver Spring). 2012 Oct;20(10):2124-32. doi: 10.1038/oby.2012.53. Epub 2012 Mar 7.

  PMID: 22395811 BACKGROUND

• Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

  PMID: 7749697 BACKGROUND

• Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237.

  PMID: 14627461 BACKGROUND

Related Links

• The ASMBS textbook of bariatric surgery

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Michel VIX, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, open-label study

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: September 11, 2020
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)