Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497946
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-13
Brief Title:
Effects of SlimTrack Platform on Diet Adherence Anthropometry and Arterial Stiffness in Postmenopausal Women
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Instituto de Cardiologia do Rio Grande do Sul
Study Overview
Official Title:
Effects of the SlimTrack Platform on Diet Adherence Body Weight Variation Anthropometric Variables and Arterial Stiffness in Postmenopausal Women Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
SlimTrack
Brief Summary:
IntroductionThe weight gain expected in the postmenopausal period has deleterious effects on the physical and mental health of the female population Management of this situation strongly recommends regular exercise behavioral and psychological interventions and dietary control Activities of this nature can be carried out online The SlimTrack Platform is an interactive digital platform for management and treatment of overweight and obesity in Non-Dietary Weight Loss basis The first phase consisting of 3 stages of 7 days total 21 days presents tools to deal with thoughts and emotions in addition to offering a series of physical activities that promote body self-awareness and movement needs Therefore this study aims to evaluate the effects of this MVP on adherence to the diet body weight variation anthropometric variables and arterial stiffness in postmenopausal women in addition to verifying the accuracy of self-reported measurements on the platform MethodsRandomized clinical trial will recruit overweight and obese volunteers to evaluate body weight variation anthropometric variables and arterial stiffness oscillometric method obtaining central arterial pressure indices pulse wave velocity large artery stiffness and Aix 75 to identify stiffness of small arteries Patients will be randomized to the following interventions Diet SlimTrack Platform Diet SlimTrack Platform and Control The interventions will have in-person assistance once a week The data obtained will be analyzed by intention to treat and presented as means M standard deviation SD They will be tested for normality using the Shapiro Wilk test The differences between interventions will be made through GEE Correlations between variables will be obtained using Pearson Correlations for parametric data and Spearman Correlations for non-parametric data with a significance level of p 005 Expected resultsResults are expected that point to the effectiveness of non-dietary support SlimTrack Platform in both diet adherence and body weight reduction Furthermore through comparisons between groups it will be possible to elucidate the influences of weight reduction diet and physical activity levels on arterial stiffness
Detailed Description:
Obesity is a chronic and multifactorial disease physiologically characterized by excessive storage of body fat which may have as a risk factor certain social reasons lifestyle inappropriate food consumption extremely restrictive diets poor relationship with food low levels of physical activity among other aspects two In Brazil it is estimated that 6 in 10 Brazilians are overweight which represents 96 million overweight people in the country Furthermore according to the World Obesity Federation by the year 2035 1 in 4 people almost two billion will live with obesity BMI above 30 kgm2 Therefore obesity is the second most important risk factor for the global burden of chronic non-communicable diseases NCDs such as cardiovascular diseases high blood pressure diabetes colon rectum breast cancer and cirrhosis However absence from work psychological disorders low self-esteem and social isolation require both a physical and psychological treatment perspective
A population widely susceptible to weight gain are postmenopausal women In a physiological context postmenopause is the last phase of the climacteric period the reproductive to non-reproductive period beginning 12 months after the womans last menstruation and ending on average at 65 years of age Evidence indicates that 50 of the female population at this time has metabolic syndrome a strong tendency to accumulate visceral abdominal adiposity seen by an increased abdominal circumference changes in bone metabolism and greater susceptibility to chronic non-communicable diseases Among the chronic diseases that develop during menopause are those related to the heart with high blood pressure diabetes and coronary disease being the protagonists of this unfavorable scenario a fact already evidenced by some recent studies that point to women in menopause with a higher prevalence of central arterial stiffness
Arterial stiffness is the mechanical distension stress induced by anterograde and retrograde systolic waves which reduces the thickness and fragments elastin fibers replaced by collagen and protein matrix with less capacity to dampen pulse wave pressures increasing the stiffness of the arterial walls and the speed of anterograde and retrograde or reflex pulse waves
Arterial stiffness is assessed using Pulse Wave Velocity PWV an important marker of central artery stiffness considered an early predictor of risk for hypertension and CVD when PWV 10 ms For every 1 ms increase in PWV there is an increase in the risk of cardiovascular death cardiovascular events and death from all causes of around 14-15
A meta-analysis has already demonstrated that reducing body weight average of 8 of initial body weight achieved through diet and lifestyle changes improved PWV Both diet and regular exercise have an effect on PWV reduction in PWV as a consequence of weight reduction and reducing 7 of initial body weight has a more robust effect
Therefore the management of body weight during menopause as well as other aspects of womens health requires a broad spectrum of transdisciplinary action with dietary and non-dietary interventions as psychological support and encouragement for a more active life In this context new technologies represent a comprehensive and accessible alternative for the use of multidisciplinary tools in body weight management since technological advances have increasingly provided non-invasive methods for health management
Therefore the SlimTrack platform presents tools that help both in facing thoughts and emotions that are harmful to long-term weight loss and with physical activities that promote body self-awareness meeting the needs of physical activity and dietary guidelines contributing to a change in Lifestyle At this moment the platform is in the development process through a notice Call CNPqSEMPIMCTI nº 0212021 - RHAE Program - Line 2 - Start-Ups Process 4245092021-0 Creation of an interactive digital platform for the management and treatment of overweight and obesity - Non-Dietary Weight Loss END coordinated by Dr Cláudia Fetter and Dr Juliana Bertoletti The first phase or MVP minimum viable product is made up of 3 stages of 7 days total 21 days is in the finalization phase to be made available to the public scheduled for October 2023 More information about the platform at the link httpsdocsgooglecomdocumentd1imApA0fw1f5oqDIvegEY0X3yaE3xRxl2UkERZH_P-yAedituspsharing
Therefore in view of the above as well as the current health scenario and its demands especially regarding obesity and risk factors associated with health this project intends to evaluate the effects of the SlimTrack Platform on adherence to the diet variation body weight anthropometric variables and arterial stiffness in postmenopausal women
A population widely susceptible to weight gain are postmenopausal women In a physiological context postmenopause is the last phase of the climacteric period the reproductive to non-reproductive period beginning 12 months after the womans last menstruation and ending on average at 65 years of age Evidence indicates that 50 of the female population at this time has metabolic syndrome a strong tendency to accumulate visceral abdominal adiposity seen by an increased abdominal circumference changes in bone metabolism and greater susceptibility to chronic non-communicable diseases Among the chronic diseases that develop during menopause are those related to the heart with high blood pressure diabetes and coronary disease being the protagonists of this unfavorable scenario a fact already evidenced by some recent studies that point to women in menopause with a higher prevalence of central arterial stiffness
Arterial stiffness is the mechanical distension stress induced by anterograde and retrograde systolic waves which reduces the thickness and fragments elastin fibers replaced by collagen and protein matrix with less capacity to dampen pulse wave pressures increasing the stiffness of the arterial walls and the speed of anterograde and retrograde or reflex pulse waves
Arterial stiffness is assessed using Pulse Wave Velocity PWV an important marker of central artery stiffness considered an early predictor of risk for hypertension and CVD when PWV 10 ms For every 1 ms increase in PWV there is an increase in the risk of cardiovascular death cardiovascular events and death from all causes of around 14-15
A meta-analysis has already demonstrated that reducing body weight average of 8 of initial body weight achieved through diet and lifestyle changes improved PWV Both diet and regular exercise have an effect on PWV reduction in PWV as a consequence of weight reduction and reducing 7 of initial body weight has a more robust effect
Therefore the management of body weight during menopause as well as other aspects of womens health requires a broad spectrum of transdisciplinary action with dietary and non-dietary interventions as psychological support and encouragement for a more active life In this context new technologies represent a comprehensive and accessible alternative for the use of multidisciplinary tools in body weight management since technological advances have increasingly provided non-invasive methods for health management
Therefore the SlimTrack platform presents tools that help both in facing thoughts and emotions that are harmful to long-term weight loss and with physical activities that promote body self-awareness meeting the needs of physical activity and dietary guidelines contributing to a change in Lifestyle At this moment the platform is in the development process through a notice Call CNPqSEMPIMCTI nº 0212021 - RHAE Program - Line 2 - Start-Ups Process 4245092021-0 Creation of an interactive digital platform for the management and treatment of overweight and obesity - Non-Dietary Weight Loss END coordinated by Dr Cláudia Fetter and Dr Juliana Bertoletti The first phase or MVP minimum viable product is made up of 3 stages of 7 days total 21 days is in the finalization phase to be made available to the public scheduled for October 2023 More information about the platform at the link httpsdocsgooglecomdocumentd1imApA0fw1f5oqDIvegEY0X3yaE3xRxl2UkERZH_P-yAedituspsharing
Therefore in view of the above as well as the current health scenario and its demands especially regarding obesity and risk factors associated with health this project intends to evaluate the effects of the SlimTrack Platform on adherence to the diet variation body weight anthropometric variables and arterial stiffness in postmenopausal women
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