Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Obesity

Intervention / Treatment
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* Other: Quarterly remote motivational interviews


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard multidisciplinary follow-up reinforced with telemedicine<br>Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews) | Other: Quarterly remote motivational interviews<br>* Remote motivational interview will be in the form of quarterly telephone call (at 3, 6 and 9 months after the start of annual follow up; the patient is seen again at 12 months as part of the annual follow-up) and this for 4 years. It will be performed by medical staff trained in motivational interviewing and who have completed at least 40 hours training in therapeutic education<br>|
| No Intervention: Standard multidisciplinary follow up<br>Standard annual multidisciplinary follow-up without telemedicine follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of patients lost to follow up | Rates of patients lost to follow up measured in both arms and compared 4 years after randomization | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evolution of quality of life, self-esteem and perceived health compared to baseline | The evolution of quality of life, self-esteem and perceived health will be measured using the Duke questionnaire, and will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization | 1,2,3 and 4 years | 
| Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization | Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization | 1,2 and 3 years | 
| 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. | 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. | 1,2,3 and 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, public health, telemedicine