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

NCT05954377 | Not Yet Recruiting

• 1 other identifier: STROBERRY
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

obesity; public health; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The evolution of quality of life, self-esteem and perceived health compared to baseline

  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

  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.

  1,2,3 and 4 years

Study Arms (2)

Standard multidisciplinary follow-up reinforced with telemedicine

EXPERIMENTAL

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

Other: Quarterly remote motivational interviews

Standard multidisciplinary follow up

NO INTERVENTION

Standard annual multidisciplinary follow-up without telemedicine follow up

Interventions

Quarterly remote motivational interviews OTHER

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

Standard multidisciplinary follow-up reinforced with telemedicine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique Saint-François

Châteauroux, 36000, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Françoise LEVITTA, MD

CONTACT

06 78 57 01 42; françoise.levitta@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FR (1)