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

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quarterly remote motivational interviews
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring obesity, public health, telemedicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique Saint-François

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard multidisciplinary follow-up reinforced with telemedicine

Standard multidisciplinary follow up

Arm Description

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

Standard annual multidisciplinary follow-up without telemedicine follow up

Outcomes

Primary Outcome Measures

Rates of patients lost to follow up
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
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
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.
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.

Full Information

First Posted
July 12, 2023
Last Updated
July 24, 2023
Sponsor
Elsan
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1. Study Identification

Unique Protocol Identification Number
NCT05954377
Brief Title
Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2029 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, public health, telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 program
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard multidisciplinary follow-up reinforced with telemedicine
Arm Type
Experimental
Arm Description
Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)
Arm Title
Standard multidisciplinary follow up
Arm Type
No Intervention
Arm Description
Standard annual multidisciplinary follow-up without telemedicine follow up
Intervention Type
Other
Intervention Name(s)
Quarterly remote motivational interviews
Intervention Description
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 Measure Information:
Title
Rates of patients lost to follow up
Description
Rates of patients lost to follow up measured in both arms and compared 4 years after randomization
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The evolution of quality of life, self-esteem and perceived health compared to baseline
Description
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
Title
Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization
Description
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
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Françoise LEVITTA, MD
Phone
06 78 57 01 42
Ext
+33
Email
françoise.levitta@orange.fr
Facility Information:
Facility Name
Clinique Saint-François
City
Châteauroux
ZIP/Postal Code
36000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise LEVITTA, MD
Phone
06 78 57 01 42
Ext
+33
Email
françoise.levitta@orange.fr

12. IPD Sharing Statement

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

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