An interventional study of Quarterly remote motivational interviews in Obesity, sponsored by Elsan. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Elsan · Not applicable, Interventional, and Supportive care
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
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 116 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non Inclusion Criteria:
Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)
Other: Quarterly remote motivational interviews
Standard annual multidisciplinary follow-up without telemedicine follow up
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
Rates of patients lost to follow up
Rates of patients lost to follow up measured in both arms and compared 4 years after randomization
Time frame: 4 years
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
Time frame: 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
Time frame: 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.
Time frame: 1,2,3 and 4 years
Start is estimated for Sep 2024; primary completion for Mar 2030, 66 months later.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 66 months is above that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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