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

NCT04282304 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Michel VIX, MD, PhD · Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2025-04-04
Completion
2025-04-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282304 on ClinicalTrials.gov