About this trial
This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on young adults (age 18 to 25 y). The main purpose is to study whether the healthy lifestyle recommender solution, reflecting a multi-portfolio intervention and developed within this project, is well accepted by the participants, has a decent adherence (i.e. user time of the app), and whether the overall design is well suited to the participants, in order that they will improve dietary habits. This study will be of longitudinal design without a control group.
At present, numbers of persons with overweight and obesity continue to grow in most countries worldwide. Young adults are at risk since in in this period of life most people start to be independent from their families, with the consequent decisions about their food and lifestyle choices. It is frequent that at this time an increase in irregularity of meals and unhealthy food choices, occurs, together with changes in physical activity habits and social or individual pressures. Because of this, it is essential to give tools to these individuals that will allow them to make healthy choices and to have healthy habits, since they will be the future adult population that will raise and inspire the next generation. As solutions to combat the trend toward increasing overweight and obesity are much in need, the present study aims to intervene with the developed healthy lifestyle recommender solution to address various factors known to constitute a risk for developing obesity, including socio-demographic aspects, psychological/behavioural ones, physical activity, dietary patterns, among other. Such a multi-dimensional portfolio approach is believed to be very much needed for the prevention of obesity and co-morbidities, and the personalization of the solution, as well as the nudging/gamification.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
To be young adult (age 18-25 y)
To reside in Portugal
To be overweight (BMI between 25-30 kg/m2)
Women and men
Disqualifiers
To have a manifest chronic diseases (e.g. cancer)
To be already in energy restriction or following a specific diet (on their own or advised by their physician)
To have eating behavior pathologies.
Trial design
Single group
Treatments tested in this trial
HealthyW8 Digital Twin of healthy lifestyle recommendations
DeviceThe applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis, but with a different purpose. Moreover, the type of digital solution that will be tested will put together different aspects that are not usually to see together in the same application. These different lifestyle aspects will be used for personalized recommendations.
Treatment groups
Trial outcomes
Primary outcomes
Adherence to digital tool
Adherence time to the lifestyle recommender solution, in order to determine the success of application of the healthy-lifestyle recommender solution to the target population (the young adults).
Satisfaction relative to the digital solution
The satisfaction for the use of the digital solution will be assessed through questionnaires addressing the user-friendliness and limitation or problems encountered. Scales will be used, where higher scores mean higher satisfaction.
Secondary outcomes
Anthropometry
Secondary outcomes (measured at the end of the 3-month period of the pilot): Change of BMI, relatively to the beginning of the intervention.
Fat Mass
Reduction of fat mass will be determined by measuring body composition through bio impedance at beginning and end of 3-month trial. The difference will allow to assess if fat mass decreased or increased, during this period.
Blood Pressure
Blood pressure (systolic, diastolic) will be measured at the beginning and at the end of the 3-month trial.
Salivary biomarkers
Saliva composition will be assessed for measuring concentration of C-reactive protein, salivary IgA, glucose and insulin. This will be done at the beginning and at the end of the 3-month trial, to assess changes during this period.
Other outcomes
Antropometric data
Height and body weight will be measured to calculate BMI, both at beginning and at the end of 3-month period.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: