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Premature termination due to lack of inclusion. Behavioral preparation is perceived as too restrictive by patients. Furthermore, the Covid and post-covid period has drastically restricted the possibilities of support for behavioral preparation.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | The patients in this arm will have usual care during preoperative period, bariatric surgery and follow-up. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative usual care | Behavioral | Usual care during the preoperative preparation for bariatric surgery consists of:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Before preparation, before surgery and 24 months after surgery |
| Changes in the physical status in terms of walking abilities |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michel VIX, MD, PhD | Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne, NHC | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24239920 | Background | 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. | |
| 28117037 |
| Label | URL |
|---|---|
| The ASMBS textbook of bariatric surgery | View source |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Prospective, randomized, controlled, open-label study
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|
| Preoperative intensive behavioral lifestyle intervention | Behavioral | The intensive behavioral lifestyle intervention program takes place over 4 weeks of 5 days. It includes:
|
|
Changes in 6-min walk test: the distance (in meters) that the patient is able to walk in 6 minutes |
| 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 | 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 | Changes in hip circumference measured in centimetres | 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 | Left liver volume, as measured by Magnetic Resonance Imaging (MRI) | Before preparation, before surgery and 24 months after surgery |
| Changes in surgical difficulty in terms of visceral flat volume | Visceral Fat volume, as measured by Magnetic Resonance Imaging (MRI) on a 1 cm slide at L2-L3 level | Before preparation, before surgery and 24 months after surgery |
| Comparison of surgical difficulty in terms of surgery duration | Total duration of Surgery, in minutes, for each group | At time of surgery |
| Comparison of surgical difficulty in terms of gastric pouch positioning duration | Time from trocar positioning to fashioning the gastric pouch, in minutes, for each group | At time of surgery |
| Comparison of surgical difficulty in terms of postoperative hospitalisation duration | Duration of the hospitalisation stay after the surgery, in days, for each group | At time of surgery |
| Changes in the quality of life by the mean of the Gastrointestinal Quality of Life Index (GIQLI) | The GIQLI (Gastrointestinal Quality of Life Index) questionnaire is a digestive quality of life score including 36 items dealing with symptoms, physical status, emotions, social problems, and the effect of medical treatment in relation with gastro-intestinal disorders or procedures. The score is between 0 and 144, the higher the score, the better the quality of life. | before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery |
| Changes in the quality of life by the mean of a quality of life questionnaire specialized in bariatric surgery | "Moorehead-Ardelt Quality of Life Questionnaire II" (M-A-QoLQII) was originally designed as a disease-specific instrument to measure postoperative outcomes of self-perceived QoL in obese patients. Six areas are examined: self-esteem, physical well-being, social relationships, work, sexuality, and eating behavior. Each item is evaluated on a 10-point scale and scored from -0.5 to +0.5. The higher the score, the better the quality of life. | before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery |
| Changes in the remission rate of fatty liver | the remission rate of the fatty liver is assessed by MRI (Magnetic Resonance Imaging) which provides measurements of the liver fatty infiltration | Before preparation, before surgery and 24 months after surgery |
| Changes in liver elasticity | The liver elasticity is assessed by Magnetic Resonance Elastography (MRE) which provides quantitative maps of its stiffness | Before preparation, before surgery and 24 months after surgery |
| Changes in iron overload in the liver | The iron overload in the liver is assessed through Magnetic Resonance Imaging (MRI) measurement of the tissue relaxivity in T2 phase | Before preparation, before surgery and 24 months after surgery |
| Changes in LDL cholesterol levels | Changes in LDL cholesterol levels (grams per liter) | Before preparation, before surgery and 24 months after surgery |
| Changes in insulin resistance | Changes in Homeostatic Model Assessment of Insulin Resistance(HOMA-IR) levels is calculated as follow: HOMA - IR = Insulin x Glucose / 22.5 | Before preparation, before surgery and 24 months after surgery |
| Surgical complication assessment | percentage of patients presenting a complication | Up to 24 months after surgery |
| 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. |
| 22395811 | 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. |
| 7749697 | 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. |
| 14627461 | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |