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

April 23, 2024 updated by: Elsan

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of patients lost to follow up
Time Frame: 4 years
Rates of patients lost to follow up measured in both arms and compared 4 years after randomization
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evolution of quality of life, self-esteem and perceived health compared to baseline
Time Frame: 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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STROBERRY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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