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

NCT06497946 | Recruiting

• 1 other identifier: 6092-23
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Obesity; Overweight

Keywords

Obesity; Menopause; Weight Loss; Digital Platform; Exercises; Eating Behavior

Outcome Measures

Primary Outcomes (1)

• Arterial Stiffness (m/s)

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

  Up to 21 days

Secondary Outcomes (3)

• Anthropometric Measures (cm)

  Up to 21 days

• Physical Activity Levels

  Up to 21 days

• Adherence to Diet

  Up to 21 days

Study Arms (4)

SlimTrack

ACTIVE COMPARATOR

Use of the SlimTrack Plataform

Behavioral: SlimTrack Plataform

SlimTrack + Diet Prescription

ACTIVE COMPARATOR

Use of the SlimTrack Plataform + diet prescription

Behavioral: SlimTrack Plataform; Behavioral: Diet prescription

Diet Prescription

ACTIVE COMPARATOR

Use of Diet Prescription

Behavioral: Diet prescription

Controll

NO INTERVENTION

Tips for health with delivery of graphic material

Interventions

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

SlimTrack; SlimTrack + Diet Prescription

Diet prescription BEHAVIORAL

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

Diet Prescription; SlimTrack + Diet Prescription

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Cis Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Menopause
• Overweight
• Obesity
• Sedentary lifestyle

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-130, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior; Behavior, Animal

Study Officials

• Fernanda Ms Poester, Graduated

  Instituto de Cardiologia RS

  STUDY DIRECTOR

Central Study Contacts

Mariana Ms Ávila, Graduated

CONTACT

51996540423; nutmarianaavila@gmail.com

Claudia Ms Fetter, Doctor

CONTACT

51984516888; profclaudiafetter@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 12, 2024
• Study Start: July 10, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)