Clinical trial NCT05954377: Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program
Official title: Prospective, Single-center, Randomized, Open Label Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up, Strengthening an Obesity Program in Berry (FRANCE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: obesity
public health
telemedicine
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study concerns patients who ended the 6 months obesity treatment program proposed by the center. At the end of this 6 months care phase, patients will be randomized in 2 groups (ratio 1:1).

The intervention will be and addition of telemedicine quarterly follow up (remote motivational interviews) to the standard multidisciplinary follow-up post care management program
Primary purpose: SUPPORTIVE_CARE

Brief summary: STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Detailed description: Obesity became a major public health issue in France. In 2019, obesity represented 5% of annual costs in health and was responsible of a 2.7% lost in France's Gross Domestic Product. In the scop of french health ministry's recommendations for obese patients'care and the territorial healthcare program; Saint-François' hospital set up 3 healthcare programs: "medical obesity"," interventional" and "post surgery". A very few number of studies aim to asse the efficacity of a long-term telemedicine follow-up after a bariatric medical care program. STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of a long term, telemedical, personalized, educative quarterly, follow-up (4 years follow up), in addition to standard follow-up, strengthening an Obesity program in Berry (FRANCE). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Eligibility criteria: Inclusion Criteria:

* Woman or Male aged from 18 to 60 years old included
* Patient in obesity (BMI\> or = 30)
* Patient who has completed a multidisciplinary medical program for obesity management, as a first- or second-line intention (after initial obesity management) at the investigating center
* Affiliation to a social security scheme
* Patient informed of the study and who had signed the informed consent form

Non Inclusion Criteria:

* Management of obesity within the framework of an exclusively interventional program, without redirection to a medical program
* Managing obesity as part of a post-operative program
* Pregnant or breastfeeding women
* Patients deprived of liberty
* Patients under legal protection

Primary outcomes:
measure: Rates of patients lost to follow up
timeFrame: 4 years
Secondary outcomes:
measure: The evolution of quality of life, self-esteem and perceived health compared to baseline
timeFrame: 1,2,3 and 4 years
measure: Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization
timeFrame: 1,2 and 3 years
measure: Change in waist circumference (cm) compared with the baseline measurement will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization.
timeFrame: 1,2,3 and 4 years
Other outcomes:
Locations:
city: Châteauroux
country: France
facility: Clinique Saint-François
Study officials:
References: