Clinical trial NCT04282304: Randomised Trial of Intensive Behavioral Lifestyle Intervention Versus Usual Preparation for Bariatric Surgery
Official title: Randomised Trial of Comprehensive, Intensive, On-site Behavioural Lifestyle Intervention Versus Usual Care During the Preoperative Preparation for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Morbid Obesity
Keywords: Behavioral intervention
Severe obesity
Weight loss
Bariatric surgery
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, open-label study
Primary purpose: TREATMENT

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.

Detailed description: Obesity is a complex, multifactorial pathology that has major public health importance. Lifestyle modification is the cornerstone of all obesity treatments, including surgery. Throughout the non-surgical treatment options, high-intensity, on-site comprehensive lifestyle intervention has demonstrated the best efficacy in obtaining weight loss, but with a risk of progressive weight regain, after 6 months (1). In obese adults, bariatric surgery produces greater weight loss and weight loss maintenance than the conventional medical treatment and lifestyle intervention (1).

There is no consensus on whether combining these two approaches (i.e. high-intensity, on-site comprehensive lifestyle intervention and bariatric surgery) results in enhanced weight loss or more sustainable outcomes. The present randomized trial aims to answer this question.

Patients preparing for bariatric surgery will be randomized between two groups. The first group will receive the usual care as recommended by the French Health Authority ("Haute Autorité de santé"), including 6 months of endocrine and nutritional follow-up and educational intervention. The second group will receive a high-intensity, 4 weeks on-site comprehensive lifestyle intervention, including prescription of a moderately reduced-calorie diet, a program of increased physical activity, and behavioral management. The patients from both groups will then be operated on and followed for at least 2 years. Complete work-up, including clinical examination, comorbidity assessment, MRI of the liver, thigh and abdominal fat, 6 minutes' walk test, quality of life questionnaires will be performed at the begging of the follow-up, after the preparation (usual care or intensive) and 2 years after surgery. Clinical and biological assessment will be performed regularly after surgery, and technical details from the bariatric interventions will be analyzed in order to assess the eventual facilitation of the gestures in the intervention group.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 in periods of exclusion (determined by a previous or ongoing study)
* Patient under safeguard of justice
* Patient under guardianship

Primary outcomes:
measure: Changes in body weight
timeFrame: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Excess weight loss
timeFrame: 2 years after surgery
measure: Changes in Body Mass Index (BMI)
timeFrame: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Secondary outcomes:
measure: Changes in the physical status in terms of muscle/fat report
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in the physical status in terms of walking abilities
timeFrame: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Changes in the physical status in terms of waist circumference
timeFrame: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Changes in physical status in terms of hip circumference
timeFrame: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Changes in surgical difficulty in terms of left liver volume
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in surgical difficulty in terms of visceral flat volume
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Comparison of surgical difficulty in terms of surgery duration
timeFrame: At time of surgery
measure: Comparison of surgical difficulty in terms of gastric pouch positioning duration
timeFrame: At time of surgery
measure: Comparison of surgical difficulty in terms of postoperative hospitalisation duration
timeFrame: At time of surgery
measure: Changes in the quality of life by the mean of the Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Changes in the quality of life by the mean of a quality of life questionnaire specialized in bariatric surgery
timeFrame: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
measure: Changes in the remission rate of fatty liver
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in liver elasticity
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in iron overload in the liver
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in LDL cholesterol levels
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Changes in insulin resistance
timeFrame: Before preparation, before surgery and 24 months after surgery
measure: Surgical complication assessment
timeFrame: Up to 24 months after surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
name: Michel VIX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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