Impact of SMS Reminder on Weight Loss, As Part of a Health Pathway in Patients with Prediabetes (PREDIABCOACH)

NCT ID: NCT06477900

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2028-11-30

Brief Summary

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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

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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.

Conditions

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SMS receiption

150 participants will follow the FindRiscPei-CPTM program (current care) and will also receive 72 SMS messages over 6 months encouraging them to take part in sports and offering nutritional advice.

Group Type EXPERIMENTAL

SMS reception

Intervention Type OTHER

reception of 72 SMS encouraging physical activity and nutritional advice

No SMS

150 participants will only follow the FindRiscPei-CPTM program (current care) and will not receive SMS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMS reception

reception of 72 SMS encouraging physical activity and nutritional advice

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LERUSTE Sebastien, Dr

Role: PRINCIPAL_INVESTIGATOR

Réunion Island University

Locations

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Communauté Professionnelle Territoriale de Santé (CPTS RéSO)

Saint-Louis, Réunion, France

Site Status RECRUITING

Territorial Health Professional Community (CPTS) Grand Sud

Saint-Philippe, , Reunion

Site Status NOT_YET_RECRUITING

Countries

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France Reunion

Central Contacts

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Benedicte ARTARIT

Role: CONTACT

+262262905284

Facility Contacts

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Philippe GOMARD, Dr

Role: primary

+26226 421270

Sebastien LERUSTE, Dr

Role: primary

+262 262 37 10 10

Other Identifiers

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2023/CHU/30

Identifier Type: -

Identifier Source: org_study_id

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