Clinical trial NCT06477900: Impact of SMS Reminder on Weight Loss, As Part of a Health Pathway in Patients with Prediabetes (PREDIABCOACH)
Official title: Impact of SMS Reminder on Weight Loss, As Part of a Hygieno-dietary Health Pathway in Patients with Prediabetes: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this interventionnal study is to demonstrate that sending SMS messages with advice on physical activity or nutrition, in addition to a program of hygienic-dietary management, significantly increases weight loss in subjects with prediabetes in La Réunion.

Indeed, type 2 diabetes is a priority health problem on Reunion Island: 10% of the population are treated for type 2 diabetes, twice as many as in France.

International studies have demonstrated the value of modifying dietary and physical activity habits to reduce the risk of transition to diabetes in patients with prediabetes Against this backdrop, a Regional Nutrition Diabetes Program (PRND) 2020-2023 was launched by Réunion's Regional Health Agency (ARS) in 2020.

Studies have also demonstrated the effectiveness of using SMS to encourage and support weight loss interventions.

So, the main question it aims to answer are:

• Does the addition of 72 SMS of physical activity and nutriton advice, to the "FindRisc Péi-CPTS" program, significantly increase weight loss by 3% after 6 months of starting the program.

FindRiscPei-CPTS program includes sports sessions, dietary consultations and therapeutic education.

The 300 participants will be randomized into two arms

* 150 participants will take part in the FindRiscPei-CPTS program + receive SMS messages
* 150 participants will only take part in the FindRiscPei-CPTS program (no SMS)

All participants will follow procedures below:

* Inclusion: assessment of weight and waist circumference, Lifestyle Questionnaire and Socio-Efficacy Questionnaire.
* Participation in Findrisk program for 3 to 9 months (+ SMS for experimental group)
* 3 follow-up visits: 3 months, 6 months and 9 months after starting the program: weight and waist measurement, self-efficacy questionnaire.

Detailed description: The outcomes of this study are :

* A better understanding of the effectiveness of the SMS intervention in the context of health and diet prevention programs for patients with pre-diabetes.
* More precise recommendations for healthcare professionals and decision-makers on the use of SMS intervention in this context.
* Improved health outcomes for prediabetes patients through the identification of effective diabetes prevention strategies.
* A positive impact on healthcare costs by reducing the progression from prediabetes to diabetes, and by reducing the use of costly healthcare associated with diabetes.

Eligibility criteria: Inclusion Criteria:

* Subject with prediabetes as defined by HAS (fasting blood glucose \> 1.10g/L and \< 1.26g/L; or blood glucose 2h after ingestion of 10g of glucose \> 1.40g/L and \< 2g/L \[HGPO test\])
* included in a health and diet care program for patients with pre-diabetes offered by one of Réunion's CPTS (FindRisc Péi-CPTS program)
* age \> 18 years
* in possession of an SMS-enabled telephone
* able to complete self-efficacy questionnaires
* not expected to move within 12 months

Exclusion Criteria:

* participant currently being monitored in the PREDIABRUN study
* protected adults (under guardianship or curatorship)
* pregnant women
* refusal to participate in the study
* patients unable to speak Creole or French

Primary outcomes:
measure: Weight loss > 3%
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: France
facility: Communauté Professionnelle Territoriale de Santé (CPTS RéSO)
state: Réunion
city: Saint-Philippe
country: Réunion
facility: Territorial Health Professional Community (CPTS) Grand Sud
Study officials:
affiliation: Réunion Island University
name: LERUSTE Sebastien, Dr
role: PRINCIPAL_INVESTIGATOR
References: