- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06477900
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
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benedicte ARTARIT
- Phone Number: +262262905284
- Email: benedicte.artarit@chu-reunion.fr
Study Locations
-
-
Réunion
-
Saint-Louis, Réunion, France, 97427
- Recruiting
- Communauté Professionnelle Territoriale de Santé (CPTS RéSO)
-
Contact:
- Philippe GOMARD, Dr
- Phone Number: +26226 421270
- Email: philippe.gomard@univ-reunion.fr
-
-
-
-
-
Saint-Philippe, Reunion, 97442
- Not yet recruiting
- Territorial Health Professional Community (CPTS) Grand Sud
-
Contact:
- Sebastien LERUSTE, Dr
- Phone Number: +262 262 37 10 10
- Email: sebastien.leruste@univ-reunion.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: LERUSTE Sebastien, Dr, Réunion Island University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/CHU/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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