Bimbingamba Zerosix Third Phase: Studying Communities

NCT05859867 | Recruiting

• 1 other identifier: CE273/2022
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Obesity; Childhood Obesity; Weight Loss; Life Style, Healthy

Keywords

Childhood Obesity

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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.

  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.

  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.

  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: 1. Very satisfied. 2. Moderately satisfied. 3. Neither satisfied nor dissatisfied. 4. Moderately dissatisfied. 5. Very dissatisfied

  Variation in Likert scale points at time 0 and 24 months.

Study Arms (2)

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.

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.

Interventions

Promotion of Healthy Nutrition and Physical Activity OTHER

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.

Children resident in the Municipality of Mondovì (Intervention group)

Eligibility Criteria

• Age: 2 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Compagnia di San Paolo: collaborator

Study Sites (1)

University of Eastern Piedmont

Novara, 28100, Italy

RECRUITING

Related Publications (27)

• 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.

  PMID: 30231531 BACKGROUND

• Belot 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.

  PMID: 21458872 BACKGROUND

• Colquitt 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.

  PMID: 26961576 BACKGROUND

• Craig 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.

  PMID: 12900694 BACKGROUND

• Crispim 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.

  PMID: 24001201 BACKGROUND

• Davison 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.

  PMID: 30900405 BACKGROUND

• Di 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.

  PMID: 31760948 BACKGROUND

• Estruch 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.

  PMID: 29897866 BACKGROUND

• Ferrari 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.

  PMID: 15466504 BACKGROUND

• Giordano 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.

  PMID: 29166878 BACKGROUND

• Gonzalez CA. The European Prospective Investigation into Cancer and Nutrition (EPIC). Public Health Nutr. 2006 Feb;9(1A):124-6. doi: 10.1079/phn2005934.

  PMID: 16512959 BACKGROUND

• Vineis 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.

  PMID: 19213558 BACKGROUND

• Hennessy 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.

  PMID: 31478333 BACKGROUND

• Larque 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.

  PMID: 31270440 BACKGROUND

• Liu 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.

  PMID: 31665040 BACKGROUND

• Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ros E, Covas MI, Fiol M, Warnberg J, Aros F, Ruiz-Gutierrez V, Lamuela-Raventos RM, Lapetra J, Munoz MA, Martinez JA, Saez G, Serra-Majem L, Pinto X, Mitjavila MT, Tur JA, Portillo MP, Estruch R; PREDIMED Study Investigators. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol. 2012 Apr;41(2):377-85. doi: 10.1093/ije/dyq250. Epub 2010 Dec 20. No abstract available.

  PMID: 21172932 BACKGROUND

• Mazarello Paes V, Ong KK, Lakshman R. Factors influencing obesogenic dietary intake in young children (0-6 years): systematic review of qualitative evidence. BMJ Open. 2015 Sep 16;5(9):e007396. doi: 10.1136/bmjopen-2014-007396.

  PMID: 26377503 BACKGROUND

• Prina S, Royer H. The importance of parental knowledge: evidence from weight report cards in Mexico. J Health Econ. 2014 Sep;37:232-47. doi: 10.1016/j.jhealeco.2014.07.001. Epub 2014 Jul 22.

  PMID: 25132149 BACKGROUND

• Reilly JJ, Martin A, Hughes AR. Early-Life Obesity Prevention: Critique of Intervention Trials During the First One Thousand Days. Curr Obes Rep. 2017 Jun;6(2):127-133. doi: 10.1007/s13679-017-0255-x.

  PMID: 28434107 BACKGROUND

• Reinehr T. Long-term effects of adolescent obesity: time to act. Nat Rev Endocrinol. 2018 Mar;14(3):183-188. doi: 10.1038/nrendo.2017.147. Epub 2017 Nov 24.

  PMID: 29170543 BACKGROUND

• Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.

  PMID: 15482620 BACKGROUND

• Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. doi: 10.1542/peds.105.1.e15.

  PMID: 10617752 BACKGROUND

• Valerio G, Maffeis C, Saggese G, Ambruzzi MA, Balsamo A, Bellone S, Bergamini M, Bernasconi S, Bona G, Calcaterra V, Canali T, Caroli M, Chiarelli F, Corciulo N, Crino A, Di Bonito P, Di Pietrantonio V, Di Pietro M, Di Sessa A, Diamanti A, Doria M, Fintini D, Franceschi R, Franzese A, Giussani M, Grugni G, Iafusco D, Iughetti L, Lamborghini A, Licenziati MR, Limauro R, Maltoni G, Manco M, Reggiani LM, Marcovecchio L, Marsciani A, Del Giudice EM, Morandi A, Morino G, Moro B, Nobili V, Perrone L, Picca M, Pietrobelli A, Privitera F, Purromuto S, Ragusa L, Ricotti R, Santamaria F, Sartori C, Stilli S, Street ME, Tanas R, Trifiro G, Umano GR, Vania A, Verduci E, Zito E. Diagnosis, treatment and prevention of pediatric obesity: consensus position statement of the Italian Society for Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics. Ital J Pediatr. 2018 Jul 31;44(1):88. doi: 10.1186/s13052-018-0525-6.

  PMID: 30064525 BACKGROUND

• Venturelli F, Ferrari F, Broccoli S, Bonvicini L, Mancuso P, Bargellini A, Giorgi Rossi P. The effect of Public Health/Pediatric Obesity interventions on socioeconomic inequalities in childhood obesity: A scoping review. Obes Rev. 2019 Dec;20(12):1720-1739. doi: 10.1111/obr.12931. Epub 2019 Aug 29.

  PMID: 31468647 BACKGROUND

• Muros J. J. and E. Knox (2020), Mediterranean diet and mental well-being in the young, The Mediterranean Diet. An Evidence-Based Approach, 2nd Edition - July 4, 2020, • Editors: Victor Preedy, Ronald Watson. Paperback ISBN: 9780128186497

  BACKGROUND

• Blanchflower, D.G., Oswald, A.J. & Stewart-Brown, S. Is Psychological Well-Being Linked to the Consumption of Fruit and Vegetables?. Soc Indic Res 114, 785-801 (2013). https://doi.org/10.1007/s11205-012-0173-y

  BACKGROUND

• Cuadros-Meñaca A., Thomsen M. R., Nayga R. M. (2022), The effect of breakfast after the bell on student academic achievement, Economics of Education Review, Volume 86, 2022.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Flavia Prodam

CONTACT

+39 0321 660 693; flavia.prodam@med.uniupo.it

Piermarco Ferraresu

CONTACT

+39 0131283819; piermarco.ferraresi@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in Clinical Nutrition and MD

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 16, 2023
• Study Start: April 15, 2023
• Primary Completion: April 15, 2025
• Study Completion: December 31, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

IT (1)