Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quarterly remote motivational interviews.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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
- Other Quarterly 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
Primary outcome measures
- Rates of patients lost to follow up [Time frame: 4 years]
Secondary outcome measures (3)
- The evolution of quality of life, self-esteem and perceived health compared to baseline [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 [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. [Time frame: 1,2,3 and 4 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Clinique Saint-François — Châteauroux
Identifiers
NCT: NCT05954377 · STROBERRY