Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477900
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Impact of SMS Reminder on Weight Loss as Part of a Health Pathway in Patients With Prediabetes PREDIABCOACH
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDIABCOACH
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 Réunions 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
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 Réunions 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None