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

Obesity Clinical Trial

— STROBERRY  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954377
• Other study ID #: STROBERRY
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2030

Study information

• Verified date: April 2024
• Source: Elsan
• Contact: Françoise LEVITTA, MD
• Phone: 06 78 57 01 42
• Email: françoise.levitta[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Clinique Saint-François	Châteauroux

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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