NCT06497946 Effects of SlimTrack® Platform on Diet Adherence, Anthropometry and Arterial Stiffness in Postmenopausal Women
| NCT ID | NCT06497946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2024-07-10 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria * Menopause * Overweight * Obesity * Sedentary lifestyle Exclusion Criteria: * Use of hormone therapy * Use of pharmacologial pshychiatric medication * Recent surgery (six months) * Recent (six months) cardiardiovascular events (myocardial infarction, stroke) * Adherence to diet in the last six months * Attending to psychoterapeutic proccess
Contact & Investigator
Fernanda Ms Poester, Graduated
STUDY DIRECTOR
Instituto de Cardiologia RS
Frequently Asked Questions
Who can join the NCT06497946 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 60 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06497946 currently recruiting?
Yes, NCT06497946 is actively recruiting participants. Contact the research team at nutmarianaavila@gmail.com for enrollment information.
Where is the NCT06497946 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06497946 clinical trial?
NCT06497946 is sponsored by Instituto de Cardiologia do Rio Grande do Sul. The principal investigator is Fernanda Ms Poester, Graduated at Instituto de Cardiologia RS. The trial plans to enroll 64 participants.