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

IHU Strasbourg17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Morbid Obesity

Interventions

Preoperative usual careBEHAVIORAL

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.

Preoperative intensive behavioral lifestyle interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, France

Outcomes

Primary Outcomes

Changes in body weight

Time frame: 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

Time frame: 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)

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

Secondary Outcomes

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

Muscle/ Fat Cross Sectional Area report obtained by the mean of Magnetic Resonance Imaging (MRI)

Time frame: Before preparation, before surgery and 24 months after surgery

Changes in the physical status in terms of walking abilities

Changes in 6-min walk test: the distance (in meters) that the patient is able to walk in 6 minutes

Time frame: 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

Changes in waist circumference measured in centimetres

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

Data from ClinicalTrials.gov

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