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

Impact of SMS Reminder on Weight Loss, as Part of a Hygieno-dietary Health Pathway in Patients With Prediabetes: a Randomized Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

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

    • Réunion
      • Saint-Louis, Réunion, France, 97427
        • Recruiting
        • Communauté Professionnelle Territoriale de Santé (CPTS RéSO)
        • Contact:
      • Saint-Philippe, Reunion, 97442
        • Not yet recruiting
        • Territorial Health Professional Community (CPTS) Grand Sud
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
reception of 72 SMS encouraging physical activity and nutritional advice
No Intervention: No SMS
150 participants will only follow the FindRiscPei-CPTM program (current care) and will not receive SMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss > 3%
Time Frame: 6 month
Proportion of patients with weight loss greater than or equal to 3% at T1+6 months (comparison between FindRisc Pei-CPTS program + SMS intervention versus FindRisc Pei-CPTS program alone).
6 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: LERUSTE Sebastien, Dr, Réunion Island University

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 (Actual)

January 22, 2025

Primary Completion (Estimated)

January 22, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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