Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
318 participants
INTERVENTIONAL
2016-09-22
2023-03-31
Brief Summary
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It aims to verify the differences between the experimental group (group-based program) and the control group (individual program) in respect to the BMI z-score values between baseline measurement (beginning of treatment), final measurement (end of treatment) and 18 months follow-up.
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Detailed Description
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The potential added value of the present study concerns the better understanding of the role of psychological and emotional aspects in the treatment of childhood obesity and in maintaining results in the long term.
The clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapeutic group intervention
Patients will be called in groups every 3 months for a total of 10 meetings. At each meeting they will be weighed and measured. Each meeting will focus on a topic of nutritional/lifestyle interest and will see the co-presence of the figures of the dietician and the psychologist, in order to allow an emotional declination for all the participants.
Therapeutic Group
The first part of each meeting, lasting 45 minutes, will be held only with children and young people, while parents will wait in the waiting room. At the end of the first part, for each meeting, the children will be asked to make a commitment relating to the topics covered, which will be verified in the following meeting. Once the part with the patients has concluded, they will be accompanied to an adjacent environment where a pediatrician volunteer will be waiting for them and will offer fun and socialization activities. In the meantime, the parents will be seated and will address, together with the team staff, the same issues discussed with their children, again for a duration of approximately 45 minutes. Parents will also be invited to make a commitment similar to that required of children.
Usual care
Patients will be called individually every 3 months for a total of 10 meetings. At each meeting they will be weighed and measured. Each meeting will focus on a topic of nutritional/lifestyle interest. The meetings will be conducted by a dietician.
Usual care
The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.
Interventions
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Therapeutic Group
The first part of each meeting, lasting 45 minutes, will be held only with children and young people, while parents will wait in the waiting room. At the end of the first part, for each meeting, the children will be asked to make a commitment relating to the topics covered, which will be verified in the following meeting. Once the part with the patients has concluded, they will be accompanied to an adjacent environment where a pediatrician volunteer will be waiting for them and will offer fun and socialization activities. In the meantime, the parents will be seated and will address, together with the team staff, the same issues discussed with their children, again for a duration of approximately 45 minutes. Parents will also be invited to make a commitment similar to that required of children.
Usual care
The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.
Eligibility Criteria
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Inclusion Criteria
* No organic causes of obesity;
* Sufficient understanding and production of Italian language;
* Age between 7 and 17 years old;
* Absence of neuropsychiatric diagnosis;
* Subscription of the Informed Consent from both parents (or legal guardian).
Exclusion Criteria
* Organic causes of obesity;
* Insufficient understanding and production of Italian language;
* Age \<7 or \>17;
* Presence of neuropsychiatric diagnosis;
* One parent (or legal guardian) refuses to subscribe the Informed Consent.
7 Years
17 Years
ALL
No
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Principal Investigators
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Marta Fontana, Psycologist
Role: PRINCIPAL_INVESTIGATOR
Azienda USL - IRCCS di Reggio Emilia
References
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Panebianco D, Gallupe O, Carrington PJ, Colozzi I. Personal support networks, social capital, and risk of relapse among individuals treated for substance use issues. Int J Drug Policy. 2016 Jan;27:146-53. doi: 10.1016/j.drugpo.2015.09.009. Epub 2015 Sep 28.
Kalavainen MP, Korppi MO, Nuutinen OM. Clinical efficacy of group-based treatment for childhood obesity compared with routinely given individual counseling. Int J Obes (Lond). 2007 Oct;31(10):1500-8. doi: 10.1038/sj.ijo.0803628. Epub 2007 Apr 17.
Zeller M, Daniels S. The obesity epidemic: family matters. J Pediatr. 2004 Jul;145(1):3-4. doi: 10.1016/j.jpeds.2004.04.038. No abstract available.
Braet C, Mervielde I, Vandereycken W. Psychological aspects of childhood obesity: a controlled study in a clinical and nonclinical sample. J Pediatr Psychol. 1997 Feb;22(1):59-71. doi: 10.1093/jpepsy/22.1.59.
French SA, Story M, Jeffery RW. Environmental influences on eating and physical activity. Annu Rev Public Health. 2001;22:309-35. doi: 10.1146/annurev.publhealth.22.1.309.
Trombini E, Baldaro B, Bertaccini R, Mattei C, Montebarocci O, Rossi N. Maternal attitudes and attachment styles in mothers of obese children. Percept Mot Skills. 2003 Oct;97(2):613-20. doi: 10.2466/pms.2003.97.2.613.
Goldfield GS, Mallory R, Parker T, Cunningham T, Legg C, Lumb A, Parker K, Prud'homme D, Adamo KB. Effects of modifying physical activity and sedentary behavior on psychosocial adjustment in overweight/obese children. J Pediatr Psychol. 2007 Aug;32(7):783-93. doi: 10.1093/jpepsy/jsm017. Epub 2007 Apr 19.
Braet C, Tanghe A, Decaluwe V, Moens E, Rosseel Y. Inpatient treatment for children with obesity: weight loss, psychological well-being, and eating behavior. J Pediatr Psychol. 2004 Oct;29(7):519-29. doi: 10.1093/jpepsy/jsh054.
Hingle MD, O'Connor TM, Dave JM, Baranowski T. Parental involvement in interventions to improve child dietary intake: a systematic review. Prev Med. 2010 Aug;51(2):103-11. doi: 10.1016/j.ypmed.2010.04.014. Epub 2010 May 10.
Fonseca H, Palmeira AL, Martins SC, Falcato L, Quaresma A. Managing paediatric obesity: a multidisciplinary intervention including peers in the therapeutic process. BMC Pediatr. 2014 Apr 3;14:89. doi: 10.1186/1471-2431-14-89.
Kader M, Sundblom E, Elinder LS. Effectiveness of universal parental support interventions addressing children's dietary habits, physical activity and bodyweight: A systematic review. Prev Med. 2015 Aug;77:52-67. doi: 10.1016/j.ypmed.2015.05.005. Epub 2015 May 14.
Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol. 2007 Sep;26(5):521-32. doi: 10.1037/0278-6133.26.5.521.
Epstein LH, Leddy JJ, Temple JL, Faith MS. Food reinforcement and eating: a multilevel analysis. Psychol Bull. 2007 Sep;133(5):884-906. doi: 10.1037/0033-2909.133.5.884.
Davoli AM, Broccoli S, Bonvicini L, Fabbri A, Ferrari E, D'Angelo S, Di Buono A, Montagna G, Panza C, Pinotti M, Romani G, Storani S, Tamelli M, Candela S, Giorgi Rossi P. Pediatrician-led motivational interviewing to treat overweight children: an RCT. Pediatrics. 2013 Nov;132(5):e1236-46. doi: 10.1542/peds.2013-1738. Epub 2013 Oct 21.
Related Links
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BMI definition
national surveillance system Okkio alla SALUTE
Other Identifiers
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GET-Obesità N.01-18/02/16
Identifier Type: -
Identifier Source: org_study_id
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