ObesityBimbingambaNCT05859867
Bimbingamba Zerosix Third Phase: Studying Communities
A study testing Promotion of Healthy Nutrition and Physical Activity in people with Obesity and Childhood Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Read more about this study
- Who is it for?
- Ages 2 days to 5 years
- Conditions the study is for
- Obesity, Childhood Obesity, Weight Loss
- What is being tested?
- Promotion of Healthy Nutrition and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 0-5 year of both sex resident in the two Municipalities under evaluation
- children having date of birth between 1/1/2018 and 31/12/2022 (subjects born 5 years prior to the start of the project)
- newborns between 01/1/2023 and 21/6/2023 residing in the two municipalities under study.
Who cannot join
- Residence/domicile in the municipalities under investigation, for a period of time less than 6 months following recruitment;
- Recruitment of the child in other intervention trials of any nature.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Eastern Piedmont
Novara, 28100
Flavia Prodam, Prof.MD, +39 0321 660 693, flavia.prodam@med.uniupo.it
Piermarco Ferraresi, Prof., +39 0131283819, piermarco.ferraresi@unito.it
About this study
Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group.
Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years.
The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).
Read the detailed description
Bimbingamba is an initiative promoted by "Fondazione Compagnia di San Paolo" with the aim of achieving healthy nutrition and physical exercise among children, aged 0-7 years. The initiative will take place in Mondovì (Cuneo, Italy), selected as the intervention Municipality, and will involve resident children with their families. Due to the common interest in the topic, Compagnia di San Paolo has requested the University of Eastern Piedmont of collaborating on the project.
As reported by literature, childhood obesity presents a multifactorial origin being determined by the interaction between environmental and genetic factors. Increased habits in consuming "junk foods", sweetened beverages, unhealthy lifestyles, and low levels of physical activity are the major driving factors for the development of obesity during childhood. The restoration of a normal weight condition, especially if the ponderal excess rose in the first years of life, seems very difficult to achieve not only because of behavioral mechanisms but also of epigenetic imprinting. The interest of this study is the prevention of the obese phenotype in children together with the restoration of normal weight. There are a great number of interventions centered on the promotion of a healthy lifestyle in adolescents, but few of these are focused on infancy, especially interventions directed to the 0-7 age group. According to reported knowledge, preventing obesity in childhood is important for reducing the risk of obesity among adolescents and adults. Therefore preventing/reducing the related comorbidities.
This intervention study will be conducted in two Italian Commons, Mondovì and Savigliano, respectively selected as the interventional Municipality and control Municipality. The study will include at least 200 children between 0-7 years with their families living and residing in one of the two cities. The main objectives of this study will be the description of weight status during the time in the 0-7 aged group in relation to the socio-economic factors, parental parameters, families, and lifestyle habits. As a secondary objective, this study aims to evaluate the effectiveness of interdisciplinary interventions in the community. Therefore, evaluating lifestyle promotion, health improvement, and soft skills acquisition in the 0-7 aged group.
Interventions will be administered during organized events involving the participation of children and their families together with the presence of specialized staff (nutritionists, personal trainers, educators). During these days children will be educated in the Mediterranean diet and healthy cooking (preparing simple meals with their parents) guided by nutritionists and will be involved in recreational and motor activities to promote physical activity.
Participants' recruiting will occur during the organized events, in places of birth, kindergarten, and vaccination centers through informative materials. On the occasion of the first meeting, those parents apparently interested will be given the materials and the link for the application (https://bimbingambazerosei.app.interacta.space/) through which join the projects and fill out the informed consent for them and their children. Recruiting period will start in April 2023.
Data collection will be performed by the specialized personnel by using specific and validated questionnaires, by taking clinical and non-clinical data, and by data arriving from health sources (i.e.: emergency accesses). All data will be registered in REDCap.
The study is thought to last 2 years, pre-intervention data will be collected at time (t) 0 (during recruiting), while post-intervention data will be collected at t24 (end of the study). Among the possible outcomes of treatment have been identified the percentage of children that are average weight or overweight, the number of children having a Mediterranean diet regimen before and after the educational period, the kind of family diet, and the level of physical activity.
Obtained data will be analyzed with statistical analysis (i.e. ANOVA and t.test) in order to identify the differences between the intervention and the control group. The final aim of the study is to obtain different data among the two cohorts regarding the prevalence of risk factors related to obesity, among the adherence of children and their families to the Mediterranean diet, differences in anthropometric and clinical parameters, and the ability of parents in distinguish healthy and unhealthy habits for their children.
The entire study will be conducted according to the Helsinki Declaration and following the Standards of Good Clinical Practice of the European Union.
- Conditions
- Obesity, Childhood Obesity, Weight Loss, Life Style, Healthy
- Being tested
- Promotion of Healthy Nutrition and Physical Activity
- Keywords
- Childhood Obesity
- Medical subject headings
- Obesity, Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of Healthy Nutrition and Physical ActivityOther
Through scheduled and specific activities, enrolled subjects receive information for the promotion of the Mediterranean diet and Mediterranean lifestyle habits, according to the pyramid of the Mediterranean diet. In addition, subjects receive general recommendations about the promotion of regular recreational motor activity, the pyramid of physical activity for pediatric age, and free games appropriate to age. These activities are conducted by professionals in the food (nutritionists) and sports sectors and are aimed in the preparation of simple recipes repeatable at home, and in motor play activities to encourage physical activity. Information regarding clinical, and socio-demographic parameters and family habits will be collected through validated questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Children resident in the Municipality of Mondovì (Intervention group) | Experimental | Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Mondovì.
Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023.
Children of both sex and of any ethnicity could be enrolled in the trial.
Moreover, parents of eligible and enrolled children are also considered in-study subjects. Receives: Other: Promotion of Healthy Nutrition and Physical Activity |
| Children resident in the Municipality of Savigliano (Control group) | No intervention | Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Savigliano. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weigh/overweight subjects
Variation in total body weight in children belonging to the intervention or control groups at times 0 and 24 months.
Measured: Change in body weight at time 0 and 24 months.
Rate of Mediterranean Diet (MD) adherence
Variation in nutritional habits (Western Diet to Mediterranean Diet) in both control and intervention groups at times 0 and 24 months. Habits in consuming MD are evaluated with KIDMED (Mediterranean Diet Quality Index) questionnaire, the scores are as follows:
total score = 12 points lower than 3 = low adherence to MD between 4-7= moderate adherence to MD higher than 8= high adherence to MD
Measured: Change in KIDMED score at time 0 and 24 months.
Physical activity level
Variation in physical activity level assessed by the International Physical Activity Questionnaire "IPAQ" in both control and intervention groups at time t0 and 24 months.
IPAQ scale is based on MET (minutes of physical activity per week):
lower than 30 minutes per day = low level of physical activity equal to 30 minutes per day= moderate level of physical activity higher than 3000 minutes per week (MET)= high level of physical activity
Measured: Change in IPAQ score at time 0 and 24 months.
Adherence to Mediterranean Diet
Evaluate the Mediterranean Diet adherence (consumption of fruit, vegetables, nuts, extra virgin olive "EVO" oil, and so on) before and after the intervention in both control and intervention groups.
The questionnaire will be performed on time t0 (time of enrollment) and time t24 (24 months later).
This questionnaire gives as results the percentage of macronutrient and micronutrient consumption and the association with Mediterranean Diet adherence.
Measured: Changes in the adherence of Mediterranean Diet between 0 and 24 months.
Nutritional habits
Nutritional habits will be evaluated in both the control and intervention groups through the use of the Andromeda questionnaire. This questionnaire will be performed at time 0 (during the enrollment) and 24 months later.
Andromeda is a questionnaire that collects information on eating habits in terms of the frequency of food consumption in the last year. Therefore, the questionnaire assesses dietary habits before the start of the observation period (t0) and 24 months (two years) after the observation or intervention period.
There is no score for this questionnaire, it divides food into macro-categories giving information about the nutrients assumption.
Measured: Changes in nutritional habits between time 0 and 24 months
Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC)
Comparison in number of times visiting ER and PFC among the intervention and control group at times 0 and 24 months.
Measured: Changes in the ER and PFC accesses at time 0 and 24 months.
Change in physiological parameters
Variation in self-confidence, self-control, and socialization level in control and intervention groups at times 0 and 24 months. These physiological parameters are evaluated through the use of Likert scale having 5 points:
- Very satisfied.
- Moderately satisfied.
- Neither satisfied nor dissatisfied.
- Moderately dissatisfied.
- Very dissatisfied
Measured: Variation in Likert scale points at time 0 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Apr 2023
- Primary completion15 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Compagnia di San Paolo
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859867
- Sponsor's protocol ID
- CE273/2022
- Acronym
- Bimbingamba
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Archero F, Ricotti R, Solito A, Carrera D, Civello F, Di Bella R, Bellone S, Prodam F. Adherence to the Mediterranean Diet among School Children and Adolescents Living in Northern Italy and Unhealthy Food Behaviors Associated to Overweight. Nutrients. 2018 Sep 18;10(9):1322. doi: 10.3390/nu10091322.
PubMed 30231531Belot M, James J. Healthy school meals and educational outcomes. J Health Econ. 2011 May;30(3):489-504. doi: 10.1016/j.jhealeco.2011.02.003. Epub 2011 Mar 1.
PubMed 21458872Colquitt JL, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Cochrane Database Syst Rev. 2016 Mar 10;3(3):CD012105. doi: 10.1002/14651858.CD012105.
PubMed 26961576Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Crispim SP, Nicolas G, Casagrande C, Knaze V, Illner AK, Huybrechts I, Slimani N. Quality assurance of the international computerised 24 h dietary recall method (EPIC-Soft). Br J Nutr. 2014 Feb;111(3):506-15. doi: 10.1017/S0007114513002766. Epub 2013 Sep 4.
PubMed 24001201Davison KK, Gavarkovs A, McBride B, Kotelchuck M, Levy R, Taveras EM. Engaging Fathers in Early Obesity Prevention During the First 1,000 Days: Policy, Systems, and Environmental Change Strategies. Obesity (Silver Spring). 2019 Apr;27(4):525-533. doi: 10.1002/oby.22395.
PubMed 30900405Di Cesare M, Soric M, Bovet P, Miranda JJ, Bhutta Z, Stevens GA, Laxmaiah A, Kengne AP, Bentham J. The epidemiological burden of obesity in childhood: a worldwide epidemic requiring urgent action. BMC Med. 2019 Nov 25;17(1):212. doi: 10.1186/s12916-019-1449-8.
PubMed 31760948Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
PubMed 29897866Ferrari P, Kaaks R, Fahey MT, Slimani N, Day NE, Pera G, Boshuizen HC, Roddam A, Boeing H, Nagel G, Thiebaut A, Orfanos P, Krogh V, Braaten T, Riboli E; European Prospective Investigation into Cancer and Nutrition study. Within- and between-cohort variation in measured macronutrient intakes, taking account of measurement errors, in the European Prospective Investigation into Cancer and Nutrition study. Am J Epidemiol. 2004 Oct 15;160(8):814-22. doi: 10.1093/aje/kwh280.
PubMed 15466504Giordano L, Gallo F, Petracci E, Chiorino G, Segnan N; Andromeda working group. The ANDROMEDA prospective cohort study: predictive value of combined criteria to tailor breast cancer screening and new opportunities from circulating markers: study protocol. BMC Cancer. 2017 Nov 22;17(1):785. doi: 10.1186/s12885-017-3784-5.
PubMed 29166878Gonzalez CA. The European Prospective Investigation into Cancer and Nutrition (EPIC). Public Health Nutr. 2006 Feb;9(1A):124-6. doi: 10.1079/phn2005934.
PubMed 16512959Vineis P, Riboli E. The EPIC study: an update. Recent Results Cancer Res. 2009;181:63-70. doi: 10.1007/978-3-540-69297-3_7. No abstract available.
PubMed 19213558Hennessy M, Heary C, Laws R, van Rhoon L, Toomey E, Wolstenholme H, Byrne M. The effectiveness of health professional-delivered interventions during the first 1000 days to prevent overweight/obesity in children: A systematic review. Obes Rev. 2019 Dec;20(12):1691-1707. doi: 10.1111/obr.12924. Epub 2019 Sep 2.
PubMed 31478333Larque E, Labayen I, Flodmark CE, Lissau I, Czernin S, Moreno LA, Pietrobelli A, Widhalm K. From conception to infancy - early risk factors for childhood obesity. Nat Rev Endocrinol. 2019 Aug;15(8):456-478. doi: 10.1038/s41574-019-0219-1. Epub 2019 Jul 3.
PubMed 31270440Liu Z, Xu HM, Wen LM, Peng YZ, Lin LZ, Zhou S, Li WH, Wang HJ. A systematic review and meta-analysis of the overall effects of school-based obesity prevention interventions and effect differences by intervention components. Int J Behav Nutr Phys Act. 2019 Oct 29;16(1):95. doi: 10.1186/s12966-019-0848-8.
PubMed 31665040
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimbingamba Zerosix Third Phase: Studying Communities
- ClinicalTrials.gov ID
- NCT05859867
- Acronym / sponsor ID
- Bimbingamba / CE273/2022
- Conditions
- Obesity, Childhood Obesity, Weight Loss, Life Style, Healthy
- Keywords
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Compagnia di San Paolo
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group.
Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years.
The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).
Detailed description
Bimbingamba is an initiative promoted by "Fondazione Compagnia di San Paolo" with the aim of achieving healthy nutrition and physical exercise among children, aged 0-7 years. The initiative will take place in Mondovì (Cuneo, Italy), selected as the intervention Municipality, and will involve resident children with their families. Due to the common interest in the topic, Compagnia di San Paolo has requested the University of Eastern Piedmont of collaborating on the project.
As reported by literature, childhood obesity presents a multifactorial origin being determined by the interaction between environmental and genetic factors. Increased habits in consuming "junk foods", sweetened beverages, unhealthy lifestyles, and low levels of physical activity are the major driving factors for the development of obesity during childhood. The restoration of a normal weight condition, especially if the ponderal excess rose in the first years of life, seems very difficult to achieve not only because of behavioral mechanisms but also of epigenetic imprinting. The interest of this study is the prevention of the obese phenotype in children together with the restoration of normal weight. There are a great number of interventions centered on the promotion of a healthy lifestyle in adolescents, but few of these are focused on infancy, especially interventions directed to the 0-7 age group. According to reported knowledge, preventing obesity in childhood is important for reducing the risk of obesity among adolescents and adults. Therefore preventing/reducing the related comorbidities.
This intervention study will be conducted in two Italian Commons, Mondovì and Savigliano, respectively selected as the interventional Municipality and control Municipality. The study will include at least 200 children between 0-7 years with their families living and residing in one of the two cities. The main objectives of this study will be the description of weight status during the time in the 0-7 aged group in relation to the socio-economic factors, parental parameters, families, and lifestyle habits. As a secondary objective, this study aims to evaluate the effectiveness of interdisciplinary interventions in the community. Therefore, evaluating lifestyle promotion, health improvement, and soft skills acquisition in the 0-7 aged group.
Interventions will be administered during organized events involving the participation of children and their families together with the presence of specialized staff (nutritionists, personal trainers, educators). During these days children will be educated in the Mediterranean diet and healthy cooking (preparing simple meals with their parents) guided by nutritionists and will be involved in recreational and motor activities to promote physical activity.
Participants' recruiting will occur during the organized events, in places of birth, kindergarten, and vaccination centers through informative materials. On the occasion of the first meeting, those parents apparently interested will be given the materials and the link for the application (https://bimbingambazerosei.app.interacta.space/) through which join the projects and fill out the informed consent for them and their children. Recruiting period will start in April 2023.
Data collection will be performed by the specialized personnel by using specific and validated questionnaires, by taking clinical and non-clinical data, and by data arriving from health sources (i.e.: emergency accesses). All data will be registered in REDCap.
The study is thought to last 2 years, pre-intervention data will be collected at time (t) 0 (during recruiting), while post-intervention data will be collected at t24 (end of the study). Among the possible outcomes of treatment have been identified the percentage of children that are average weight or overweight, the number of children having a Mediterranean diet regimen before and after the educational period, the kind of family diet, and the level of physical activity.
Obtained data will be analyzed with statistical analysis (i.e. ANOVA and t.test) in order to identify the differences between the intervention and the control group. The final aim of the study is to obtain different data among the two cohorts regarding the prevalence of risk factors related to obesity, among the adherence of children and their families to the Mediterranean diet, differences in anthropometric and clinical parameters, and the ability of parents in distinguish healthy and unhealthy habits for their children.
The entire study will be conducted according to the Helsinki Declaration and following the Standards of Good Clinical Practice of the European Union.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children resident in the Municipality of Mondovì (Intervention group) | Experimental | Other: Promotion of Healthy Nutrition and Physical ActivityRecruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Mondovì. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects. |
| Children resident in the Municipality of Savigliano (Control group) | No intervention | –Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Savigliano. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects. |
Who may qualify
- Ages
- 2 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 0-5 year of both sex resident in the two Municipalities under evaluation
- children having date of birth between 1/1/2018 and 31/12/2022 (subjects born 5 years prior to the start of the project)
- newborns between 01/1/2023 and 21/6/2023 residing in the two municipalities under study.
Key exclusion criteria (2 listed)
- Residence/domicile in the municipalities under investigation, for a period of time less than 6 months following recruitment;
- Recruitment of the child in other intervention trials of any nature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of Healthy Nutrition and Physical ActivityThrough scheduled and specific activities, enrolled subjects receive information for the promotion of the Mediterranean diet and Mediterranean lifestyle habits, according to the pyramid of the Mediterranean diet. In addition, subjects receive general recommendations about the promotion of regular recreational motor activity, the pyramid of physical activity for pediatric age, and free games appropriate to age. These activities are conducted by professionals in the food (nutritionists) and sports sectors and are aimed in the preparation of simple recipes repeatable at home, and in motor play activities to encourage physical activity. Information regarding clinical, and socio-demographic parameters and family habits will be collected through validated questionnaires. | Other | Children resident in the Municipality of Mondovì (Intervention group) |
Primary outcome
Rate of weigh/overweight subjects
Time frame: Change in body weight at time 0 and 24 months.
Variation in total body weight in children belonging to the intervention or control groups at times 0 and 24 months.
Rate of Mediterranean Diet (MD) adherence
Time frame: Change in KIDMED score at time 0 and 24 months.
Variation in nutritional habits (Western Diet to Mediterranean Diet) in both control and intervention groups at times 0 and 24 months. Habits in consuming MD are evaluated with KIDMED (Mediterranean Diet Quality Index) questionnaire, the scores are as follows: total score = 12 points lower than 3 = low adherence to MD between 4-7= moderate adherence to MD higher than 8= high adherence to MD
Physical activity level
Time frame: Change in IPAQ score at time 0 and 24 months.
Variation in physical activity level assessed by the International Physical Activity Questionnaire "IPAQ" in both control and intervention groups at time t0 and 24 months. IPAQ scale is based on MET (minutes of physical activity per week): lower than 30 minutes per day = low level of physical activity equal to 30 minutes per day= moderate level of physical activity higher than 3000 minutes per week (MET)= high level of physical activity
Adherence to Mediterranean Diet
Time frame: Changes in the adherence of Mediterranean Diet between 0 and 24 months.
Evaluate the Mediterranean Diet adherence (consumption of fruit, vegetables, nuts, extra virgin olive "EVO" oil, and so on) before and after the intervention in both control and intervention groups. The questionnaire will be performed on time t0 (time of enrollment) and time t24 (24 months later). This questionnaire gives as results the percentage of macronutrient and micronutrient consumption and the association with Mediterranean Diet adherence.
Nutritional habits
Time frame: Changes in nutritional habits between time 0 and 24 months
Nutritional habits will be evaluated in both the control and intervention groups through the use of the Andromeda questionnaire. This questionnaire will be performed at time 0 (during the enrollment) and 24 months later. Andromeda is a questionnaire that collects information on eating habits in terms of the frequency of food consumption in the last year. Therefore, the questionnaire assesses dietary habits before the start of the observation period (t0) and 24 months (two years) after the observation or intervention period. There is no score for this questionnaire, it divides food into macro-categories giving information about the nutrients assumption.
Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC)
Time frame: Changes in the ER and PFC accesses at time 0 and 24 months.
Comparison in number of times visiting ER and PFC among the intervention and control group at times 0 and 24 months.
Change in physiological parameters
Time frame: Variation in Likert scale points at time 0 and 24 months.
Variation in self-confidence, self-control, and socialization level in control and intervention groups at times 0 and 24 months. These physiological parameters are evaluated through the use of Likert scale having 5 points: 1. Very satisfied. 2. Moderately satisfied. 3. Neither satisfied nor dissatisfied. 4. Moderately dissatisfied. 5. Very dissatisfied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 30231531Archero F, Ricotti R, Solito A, Carrera D, Civello F, Di Bella R, Bellone S, Prodam F. Adherence to the Mediterranean Diet among School Children and Adolescents Living in Northern Italy and Unhealthy Food Behaviors Associated to Overweight. Nutrients. 2018 Sep 18;10(9):1322. doi: 10.3390/nu10091322.
- Background: PubMed 21458872Belot M, James J. Healthy school meals and educational outcomes. J Health Econ. 2011 May;30(3):489-504. doi: 10.1016/j.jhealeco.2011.02.003. Epub 2011 Mar 1.
- Background: PubMed 26961576Colquitt JL, Loveman E, O'Malley C, Azevedo LB, Mead E, Al-Khudairy L, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years. Cochrane Database Syst Rev. 2016 Mar 10;3(3):CD012105. doi: 10.1002/14651858.CD012105.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 24001201Crispim SP, Nicolas G, Casagrande C, Knaze V, Illner AK, Huybrechts I, Slimani N. Quality assurance of the international computerised 24 h dietary recall method (EPIC-Soft). Br J Nutr. 2014 Feb;111(3):506-15. doi: 10.1017/S0007114513002766. Epub 2013 Sep 4.
- Background: PubMed 30900405Davison KK, Gavarkovs A, McBride B, Kotelchuck M, Levy R, Taveras EM. Engaging Fathers in Early Obesity Prevention During the First 1,000 Days: Policy, Systems, and Environmental Change Strategies. Obesity (Silver Spring). 2019 Apr;27(4):525-533. doi: 10.1002/oby.22395.
- Background: PubMed 31760948Di Cesare M, Soric M, Bovet P, Miranda JJ, Bhutta Z, Stevens GA, Laxmaiah A, Kengne AP, Bentham J. The epidemiological burden of obesity in childhood: a worldwide epidemic requiring urgent action. BMC Med. 2019 Nov 25;17(1):212. doi: 10.1186/s12916-019-1449-8.
- Background: PubMed 29897866Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
- Background: PubMed 15466504Ferrari P, Kaaks R, Fahey MT, Slimani N, Day NE, Pera G, Boshuizen HC, Roddam A, Boeing H, Nagel G, Thiebaut A, Orfanos P, Krogh V, Braaten T, Riboli E; European Prospective Investigation into Cancer and Nutrition study. Within- and between-cohort variation in measured macronutrient intakes, taking account of measurement errors, in the European Prospective Investigation into Cancer and Nutrition study. Am J Epidemiol. 2004 Oct 15;160(8):814-22. doi: 10.1093/aje/kwh280.
- Background: PubMed 29166878Giordano L, Gallo F, Petracci E, Chiorino G, Segnan N; Andromeda working group. The ANDROMEDA prospective cohort study: predictive value of combined criteria to tailor breast cancer screening and new opportunities from circulating markers: study protocol. BMC Cancer. 2017 Nov 22;17(1):785. doi: 10.1186/s12885-017-3784-5.
- Background: PubMed 16512959Gonzalez CA. The European Prospective Investigation into Cancer and Nutrition (EPIC). Public Health Nutr. 2006 Feb;9(1A):124-6. doi: 10.1079/phn2005934.
- Background: PubMed 19213558Vineis P, Riboli E. The EPIC study: an update. Recent Results Cancer Res. 2009;181:63-70. doi: 10.1007/978-3-540-69297-3_7. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of Healthy Nutrition and Physical Activity in people with Obesity and Childhood Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Prodam (+39 0321 660 693, flavia.prodam@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weigh/overweight subjects (time frame: Change in body weight at time 0 and 24 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859867, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.