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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard multidisciplinary follow-up reinforced with telemedicine | Experimental | Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews) |
|
| Standard multidisciplinary follow up | No Intervention | Standard annual multidisciplinary follow-up without telemedicine follow up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quarterly remote motivational interviews | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Non Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Françoise LEVITTA, MD | Contact | 06 78 57 01 42 | +33 | françoise.levitta@orange.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint-François | Châteauroux | 36000 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |