PreDiabetesPREDIABCOACHNCT06477900
Impact of SMS Reminder on Weight Loss, as Part of a Health Pathway in Patients With Prediabetes (PREDIABCOACH)
A study testing SMS reception in people with PreDiabetes, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- SMS reception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jan 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
Communauté Professionnelle Territoriale de Santé (CPTS RéSO)
Saint-Louis, Réunion, 97427
Philippe GOMARD, Dr, +26226 421270, philippe.gomard@univ-reunion.fr
Reunion1 site, 1 recruiting
- Not yet recruiting
Territorial Health Professional Community (CPTS) Grand Sud
Saint-Philippe, 97442
Sebastien LERUSTE, Dr, +262 262 37 10 10, sebastien.leruste@univ-reunion.fr
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- SMS reception
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS receptionOther
reception of 72 SMS encouraging physical activity and nutritional advice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SMS reception |
| No SMS | No intervention | 150 participants will only follow the FindRiscPei-CPTM program (current care) and will not receive SMS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start22 Jan 2025
- Primary completion22 Jan 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LERUSTE Sebastien, Dr, Principal investigator, Réunion Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477900
- Sponsor's protocol ID
- 2023/CHU/30
- Acronym
- PREDIABCOACH
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06477900
- Acronym / sponsor ID
- PREDIABCOACH / 2023/CHU/30
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 22 Jan 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS receiption | Experimental | Other: SMS reception150 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. |
| No SMS | No intervention | –150 participants will only follow the FindRiscPei-CPTM program (current care) and will not receive SMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS receptionreception of 72 SMS encouraging physical activity and nutritional advice | Other | SMS receiption |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LERUSTE Sebastien, Dr principal investigator
Réunion Island University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reception in people with PreDiabetes, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedicte ARTARIT (+262262905284, benedicte.artarit@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss > 3% (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.