Empowering Healthy Lifestyle Behaviour Through Personalized Intervention Portfolios to Prevent and Control Obesity in Young Adults - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Adherence to digital tool
Study Overview
Brief Summary
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.
Detailed Description
The 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.
The investigators judge the risk for the participant as low, since only saliva will be collected which collection is totally non-invasive. The administered intervention is expected to be effective, based on the multi-level nature of the tools applied.
This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.
The investigators are aware of the potential influence of seasons and other longitudinal changes on the outcomes, however as the endpoints are rather motivation and adherence, the investigators deem the design as appropriate. Moreover, in case of salivary parameters, which can be more sensitive to this type of variation, the collection in three successive days, before and at the end of the trial (to be analysed as pooled samples) will minimize these potential effects.
The intervention is the developed eHealth solution, i.e. the healthy lifestyle recommender system. It is based on a previously developed meal recommender system, but will be much extended, resulting in a multilevel portfolio intervention regarding:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be young adult (age 18-25 y)
- •To reside in Portugal
- •To be overweight (BMI between 25-30 kg/m2)
- •Women and men
Exclusion Criteria
- •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.
Arms & Interventions
Test of healthyW8 Digital Twin of healthy lifestyle recommendations
Individuals will have access to a digital tool, putting together nutrition, physical activity and emotional aspects. Participant interaction with the tool, through registration collected or inputed by the individual will allow personalized recommendations.
Intervention: HealthyW8 Digital Twin of healthy lifestyle recommendations (Device)
Outcomes
Primary Outcomes
Adherence to digital tool
Time Frame: 3-month
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
Time Frame: 3 months
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
- Blood Pressure(3-month)
- Salivary Amylase(3-month)
- Diet(1 week)
- Anthropometry(3-month)
- Fat Mass(3-months)
- Salivary markers of stress(3-month)
- Physical activity(At the beginning of the study)
- Salivary biomarkers(3-month)
Investigators
Elsa Lamy
Principal Investigator, Head of the Laboratory of Oral Biology and Salivary Proteomics of MED, University of Evora
University of Évora