MenopauseSlimTrackNCT06497946
Effects of SlimTrack® Platform on Diet Adherence, Anthropometry and Arterial Stiffness in Postmenopausal Women
A study testing SlimTrack Plataform and Diet prescription in people with Menopause and Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Obesity, Overweight
- What is being tested?
- SlimTrack Plataform and Diet prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Menopause
- Overweight
- Obesity
- Sedentary lifestyle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-130
About this study
Official title: Effects of the SlimTrack® Platform on Diet Adherence, Body Weight Variation, Anthropometric Variables and Arterial Stiffness in Postmenopausal Women: Pilot Study
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.
Read the 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 kg/m2). 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 woman's 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 m/s. For every 1 m/s 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 women's 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 CNPq/SEMPI/MCTI nº 021/2021 - RHAE Program - Line 2 - Start-Ups, Process: 424509/2021-0 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: https://docs.google.com/document/d/1imApA0fw1f5oqDIvegEY0X3yaE3xRxl2UkERZH_P-yA/edit?usp=sharing
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.
- Conditions
- Menopause, Obesity, Overweight
- Being tested
- SlimTrack Plataform, Diet prescription
- Keywords
- Obesity, Menopause, Weight Loss, Digital Platform, Exercises, Eating Behavior
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SlimTrack PlataformBehavioural
SlimTrack Plataform requests log in and includes anthropometric data of participants, besides answers about questionaires and other tasks in online content available
Diet prescriptionBehavioural
Nutrition Professional evaluates diet habits and prescribes a reeducation method in order to fulfill better behavior towards food intake
| Study group | Role | What they receive |
|---|---|---|
| SlimTrack | Active comparator | Use of the SlimTrack Plataform Receives: Behavioral: SlimTrack Plataform |
| SlimTrack + Diet Prescription | Active comparator | Use of the SlimTrack Plataform + diet prescription Receives: Behavioral: SlimTrack Plataform; Behavioral: Diet prescription |
| Diet Prescription | Active comparator | Use of Diet Prescription Receives: Behavioral: Diet prescription |
| Controll | No intervention | Tips for health with delivery of graphic material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness (m/s)
Pulse Wave Velocity by oscilometric method, aimed to be decreased at post intervention assessment
Measured: Up to 21 days
Secondary outcomes (3)
Anthropometric Measures (cm)
Abdominal circumference aimed to be decreased at post intervention assessment
Measured: Up to 21 days
Physical Activity Levels
Inventary of Physical Activity Questionnaire (IPAQ) short version aimed to be increased at post intervention assessment
Measured: Up to 21 days
Adherence to Diet
Food Intake Questionnaire (WebDiet) aimed to be increased at post intervention assessment
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start10 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clauda Fetter, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Fernanda Ms Poester, Graduated, Study director, Instituto de Cardiologia RS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497946
- Sponsor's protocol ID
- 6092-23
- Acronym
- SlimTrack
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the SlimTrack® Platform on Diet Adherence, Body Weight Variation, Anthropometric Variables and Arterial Stiffness in Postmenopausal Women: Pilot Study
- ClinicalTrials.gov ID
- NCT06497946
- Acronym / sponsor ID
- SlimTrack / 6092-23
- Conditions
- Menopause, Obesity, Overweight
- Keywords
- Obesity, Menopause, Weight Loss, Digital Platform, Exercises, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 kg/m2). 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 woman's 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 m/s. For every 1 m/s 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 women's 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 CNPq/SEMPI/MCTI nº 021/2021 - RHAE Program - Line 2 - Start-Ups, Process: 424509/2021-0 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: https://docs.google.com/document/d/1imApA0fw1f5oqDIvegEY0X3yaE3xRxl2UkERZH_P-yA/edit?usp=sharing
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SlimTrack | Active comparator | Behavioral: SlimTrack PlataformUse of the SlimTrack Plataform |
| SlimTrack + Diet Prescription | Active comparator | Behavioral: SlimTrack Plataform, Behavioral: Diet prescriptionUse of the SlimTrack Plataform + diet prescription |
| Diet Prescription | Active comparator | Behavioral: Diet prescriptionUse of Diet Prescription |
| Controll | No intervention | –Tips for health with delivery of graphic material |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Menopause
- Overweight
- Obesity
- Sedentary lifestyle
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SlimTrack PlataformSlimTrack Plataform requests log in and includes anthropometric data of participants, besides answers about questionaires and other tasks in online content available | Behavioural | SlimTrack, SlimTrack + Diet Prescription |
| Diet prescriptionNutrition Professional evaluates diet habits and prescribes a reeducation method in order to fulfill better behavior towards food intake | Behavioural | Diet Prescription, SlimTrack + Diet Prescription |
Primary outcome
Arterial Stiffness (m/s)
Time frame: Up to 21 days
Pulse Wave Velocity by oscilometric method, aimed to be decreased at post intervention assessment
3 secondary outcomes
Anthropometric Measures (cm)
Time frame: Up to 21 days
Physical Activity Levels
Time frame: Up to 21 days
Adherence to Diet
Time frame: Up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Ms Poester, Graduated study director
Instituto de Cardiologia RS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SlimTrack Plataform and Diet prescription in people with Menopause and Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (m/s) (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.