Therapeutic Education Groups for Childhood Obesity

NCT06239662 | Completed DMC

• 1 other identifier: GET-Obesità N.01-18/02/16
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test the efficacy of an educational therapeutic intervention in treating obesity in a pediatric population. 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.

Conditions

Childhood Obesity

Keywords

Childhood obesity; Group Intervention; Psychological Aspects

Outcome Measures

Primary Outcomes (2)

• BMI z-score

  BMI z-score variation from baseline to end of treatment

  measurement at end of treatment i.e approximately 24 months after baseline measurements

• BMI z-score

  BMI z-score variation from baseline to 18 months after the and of treatment

  measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements

Secondary Outcomes (27)

• healthy dietary habits

  measurement at end of treatment i.e approximately 24 months after baseline measurements

• healthy dietary habits

  measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements

• unhealthy dietary habits

  measurement at end of treatment i.e approximately 24 months after baseline measurements

• unhealthy dietary habits

  measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements

• Biohumoral exams from blood sample: Uric acid

  measurement at end of treatment i.e approximately 24 months after baseline measurements

Study Arms (2)

Therapeutic group intervention

EXPERIMENTAL

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.

Behavioral: Therapeutic Group

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Therapeutic Group BEHAVIORAL

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.

Therapeutic group intervention

Usual care BEHAVIORAL

The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.

Usual care

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Obesity (\>= 95th percentile);
• 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).

You may not qualify if:

• Degree of obesity\< 95th percentile;
• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Related Publications (14)

• 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.

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• 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.

  PMID: 17438555 BACKGROUND

• 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.

  PMID: 15238894 BACKGROUND

• 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.

  PMID: 9019048 BACKGROUND

• 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.

  PMID: 11274524 BACKGROUND

• 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.

  PMID: 14620250 BACKGROUND

• 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.

  PMID: 17449466 BACKGROUND

• 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.

  PMID: 15347700 BACKGROUND

• 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.

  PMID: 20462509 BACKGROUND

• 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.

  PMID: 24693926 BACKGROUND

• 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.

  PMID: 25981555 BACKGROUND

• 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.

  PMID: 17845100 BACKGROUND

• 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.

  PMID: 17723034 BACKGROUND

• 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.

  PMID: 24144717 BACKGROUND

Related Links

• BMI definition
• national surveillance system Okkio alla SALUTE

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Marta Fontana, Psycologist

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 2, 2024
• Study Start: September 22, 2016
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 1, 2024

Record last verified: 2023-10