NCT04282304

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

Randomised Trial of Comprehensive, Intensive, On-site Behavioural Lifestyle Intervention Versus Usual Care During the Preoperative Preparation for Bariatric Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Preoperative usual care	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.
BEHAVIORAL	Preoperative intensive behavioral lifestyle intervention	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.

Timeline

• Start date: 2020-09-11
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2020-02-24
• Last updated: 2025-05-01

Locations

1 site across 1 country: France