Empowering Healthy Lifestyle Behaviour Through Personalized Intervention Portfolios to Prevent and Control Obesity During Vulnerable Stages of Life: The HealthyW8 Project.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,720
- Locations
- 13
- Primary Endpoint
- Change in BMI
Study Overview
Brief Summary
The goal of the HealthyW8 study (an intervention study) is:
To assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (>65 y).
The main questions it aims to answer are:
Outcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight/obesity among the described age groups.
Outcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight/obesity at described ages.
Researchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight/obesity, and related parameters (body composition and biomarkers).
Participants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.
Detailed Description
HealthyW8 will enhance early screening and prevention of obesity by making the scientific and technological breakthroughs necessary to support evidence-based clinical, environmental and policy-level decisions, while also directly empowering citizens to adopt healthy and sustainable lifestyle behaviours in a "push-pull" approach.
HealthyW8 will step up primary obesity prevention efforts across Europe, endowing them with a multi-disciplinary portfolio approach, i.e. a set of selective multi-component interventions that combine a large set of interventions and implementation options, focussing on diet, physical activity (PA), and psycho-emotional aspects.
The current approach considers obesity as a multifactorial phenomenon, necessitating a holistic, systemic approach accounting for the complexity of individual, interpersonal, organisational, community and public policy levels, as mutually reinforcing and supportive systems.
The attention will be focused on pivotal situations of transitions in the life-trajectory of individuals, which pose an elevated risk to progress from healthy weight to overweight and obesity, i.e. windows of opportunity to reduce the risk of developing obesity where the impact will have most leverage.
HealthyW8 targets vulnerable populations where transitional changes of lifestyle appear to be dominant: primary schoolchildren (5-12y, with active parent involvement), young adults (18-25y), and the elderly (>65y).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overweight (BMI between 25-30 kg/m^2)
- •To have a smart phone
Exclusion Criteria
- •Individuals with manifest chronic diseases
- •Individuals with cognitive diseases
- •Individuas not able to lead an independent life
Arms & Interventions
School-children (including families)
HLRS intervention on 5-12 year-old school-children (including families) adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).
Intervention: Intervention Group (Behavioral)
Young adults
HLRS intervention on 18-25-year-old young adults adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).
Intervention: Intervention Group (Behavioral)
Elderly people
HLRS intervention on >65-year-old elderly people adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).
Intervention: Intervention Group (Behavioral)
Outcomes
Primary Outcomes
Change in BMI
Time Frame: Baseline and every 3 months up to 12 months
The Primary Outcome (to be measured every 3 months) will be the change of BMI (kg/m\^2) measuring body weight in kilograms and height in meters\^2 as combined to obtain BMI data (kg/m\^2) after the 12-month intervention of healthy lifestyle recommender solutions (HLRS) in the selected age groups (5-12 y.o. children and families; 18-25 y.o. young adults; and \>65 y.o. elderly people).
Secondary Outcomes
- Change of visceral body fat(Baseline and every 3 months up to 12 months)
- Body composition and biomarkers(Baseline and every 6 months up to 12 months)