Effects of SlimTrack® Platform on Diet Adherence, Anthropometry and Arterial Stiffness in Postmenopausal Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorInstituto de Cardiologia do Rio Grande do Sul

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Menopause

Overweight

Obesity

Sedentary lifestyle

Disqualifiers

Use of hormone therapy

Use of pharmacologial pshychiatric medication

Recent surgery (six months)

Recent (six months) cardiardiovascular events (myocardial infarction, stroke)

Trial design

Design model

Factorial

Treatments tested in this trial

  • SlimTrack Plataform

    Behavioral

    SlimTrack Plataform requests log in and includes anthropometric data of participants, besides answers about questionaires and other tasks in online content available

  • Diet prescription

    Behavioral

    Nutrition Professional evaluates diet habits and prescribes a reeducation method in order to fulfill better behavior towards food intake

Treatment groups

64 Participants
are divided into 4 treatment groups
Group A: SlimTrackActive comparator 1 intervention
Group B: SlimTrack + Diet PrescriptionActive comparator 2 interventions
Group C: Diet PrescriptionActive comparator 1 intervention
Group D: ControllNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Arterial Stiffness (m/s)

Pulse Wave Velocity by oscilometric method, aimed to be decreased at post intervention assessment

Time frame
Up to 21 days

Secondary outcomes

1

Anthropometric Measures (cm)

Abdominal circumference aimed to be decreased at post intervention assessment

Time frame
Up to 21 days
2

Physical Activity Levels

Inventary of Physical Activity Questionnaire (IPAQ) short version aimed to be increased at post intervention assessment

Time frame
Up to 21 days
3

Adherence to Diet

Food Intake Questionnaire (WebDiet) aimed to be increased at post intervention assessment

Time frame
Up to 21 days

Other outcomes

Sponsors and contacts

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