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NCT Number: NCT05954377

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Françoise LEVITTA, MD

CONTACT

franç[email protected]

06 78 57 01 42 ext. +33

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study 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)

Acronym: STROBERRY

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 20, 2023
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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