CompletedNot Applicable

MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood

Italy226 participantsStarted 2023-10-18

Plain-language summary

Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century. The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior. To counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term. Moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective. The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children 6-11 years * children whose parents will provide written consent to participate. Exclusion Criteria: * Children who do not have inclusion criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Investigate prevalence of childhood overweight and/or obesity

Timeframe: Baseline

Investigation on adherence to Mediterranian diet

Timeframe: Baseline

Assessment of the consumption of ultra-processed food by children

Timeframe: Baseline

Investigation of family lifestyles

Timeframe: Baseline

Trial details

NCT IDNCT05966051

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Childhood Obesity trials

Plain-language summary

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children 6-11 years * children whose parents will provide written consent to participate. Exclusion Criteria: * Children who do not have inclusion criteria.