NCT06477900

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Nov 2028

First Submitted

Initial submission to the registry

June 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

June 21, 2024

Last Update Submit

March 17, 2026

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Weight loss > 3%

    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

Study Arms (2)

SMS receiption

EXPERIMENTAL

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.

Other: SMS reception

No SMS

NO INTERVENTION

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

Interventions

SMS receptionOTHER

reception of 72 SMS encouraging physical activity and nutritional advice

SMS receiption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Communauté Professionnelle Territoriale de Santé (CPTS RéSO)

Saint-Louis, Réunion, 97427, France

RECRUITING

Territorial Health Professional Community (CPTS) Grand Sud

Saint-Philippe, 97442, Reunion

NOT YET RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • LERUSTE Sebastien, Dr

    Réunion Island University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedicte ARTARIT

CONTACT

+262262905284benedicte.artarit@chu-reunion.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 27, 2024

Study Start

January 22, 2025

Primary Completion (Estimated)

January 22, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)FR(1)