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

Sponsor

Elsan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954377

Collaborator

(none)

116

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Quarterly remote motivational interviews	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 programThe 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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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)

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2029

Anticipated Study Completion Date :

Apr 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard multidisciplinary follow-up reinforced with telemedicine Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)	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
No Intervention: Standard multidisciplinary follow up Standard annual multidisciplinary follow-up without telemedicine follow up

Arm

Intervention/Treatment

Experimental: Standard multidisciplinary follow-up reinforced with telemedicine

Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)

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

No Intervention: Standard multidisciplinary follow up

Standard annual multidisciplinary follow-up without telemedicine follow up

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Saint-François	Châteauroux		France	36000

Sponsors and Collaborators

Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elsan

ClinicalTrials.gov Identifier:

NCT05954377

Other Study ID Numbers:

STROBERRY

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elsan

obesity

public health

telemedicine

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jul 27, 2023