Effects of SlimTrack® Platform on Diet Adherence, Anthropometry and Arterial Stiffness in Postmenopausal Women
NCT Number: NCT06497946
Acronym: SlimTrack
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause|Obesity|Overweight
Interventions: BEHAVIORAL: SlimTrack Plataform|BEHAVIORAL: Diet prescription
Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sex: FEMALE
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-10
Completion Date: 2025-11-30
Locations: Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Rio Grande Do Sul, 90620-130, Brazil

Summary:
Introduction:The 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. Methods:Randomized 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 \< 0.05. Expected results:Results 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.

Primary Outcome Measures: Arterial Stiffness (m/s), Pulse Wave Velocity by oscilometric method, aimed to be decreased at post intervention assessment, Up to 21 days
Secondary Outcome Measures: Anthropometric Measures (cm), Abdominal circumference aimed to be decreased at post intervention assessment, Up to 21 days|Physical Activity Levels, Inventary of Physical Activity Questionnaire (IPAQ) short version aimed to be increased at post intervention assessment, Up to 21 days|Adherence to Diet, Food Intake Questionnaire (WebDiet) aimed to be increased at post intervention assessment, Up to 21 days