Obesity
Conditions
Keywords
obesity, public health, telemedicine
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
Interventions
OTHERQuarterly remote motivational interviews
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
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of patients lost to follow up | 4 years | Rates of patients lost to follow up measured in both arms and compared 4 years after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The evolution of quality of life, self-esteem and perceived health compared to baseline | 1,2,3 and 4 years | 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 |
| 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 | Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 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 | 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. |
Countries
France
Contacts
Primary ContactFrançoise LEVITTA, MD
Outcome results
None listed