Childhood ObesityGET-ObesityNCT06239662

Therapeutic Education Groups for Childhood Obesity

A study testing Therapeutic Group in people with Childhood Obesity, run by Azienda USL Reggio Emilia - IRCCS.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Childhood Obesity
What is being tested?: Therapeutic Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 318 participants
Where: No sites listed yet
Study dates: 22 Sep 2016to 31 Mar 2023
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 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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.

About this study

Official title: Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial

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.

Read the detailed description

One of the aim of this clinical trial is to verify that the direct management of the emotional and relational aspects of patients and family plays an important role in maintaining the weight changes achieved in the long term.

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: Childhood Obesity
Being tested: Therapeutic Group, Usual care
Keywords: Childhood obesity, Group Intervention, Psychological Aspects
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06239662
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

BMI z-score
BMI z-score variation from baseline to end of treatment
Measured: 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
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements

Secondary outcomes (27)

healthy dietary habits
variation in the daily consumption (in frequency) of fruits and vegetables measurement at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
healthy dietary habits
variation in the daily consumption (in frequency) of fruits and vegetables measurement from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
unhealthy dietary habits
variation in the weekly consumption (in frequency) of packed and high-calorie food measurment at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
unhealthy dietary habits
variation in the weekly consumption (in frequency) of packed and high-calorie food measurment from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
variation in the value measurements (differences expressed in U/l) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Insulin
variation in the value measurements (differences expressed in µU/mL) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
variation in the value measurements (differences expressed mmol/moli) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
variation in the value measurements (differences expressed μIU/ml) at end of treatment i.e approximately 24 months after baseline measurements
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
variation in the value measurements (differences expressed in U/l) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Insulin
variation in the value measurements (differences expressed in µU/mL) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
variation in the value measurements (differences expressed in mmol/moli) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
variation in the value measurements (differences expressed in μIU/ml) from baseline to 18 months after the and of treatment
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
variation in TAS-20 overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements.Scoring range: 20-100; cutoff 60 (higher scores indicate greater impairment/challenges).
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
variation in TAS-20 overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. Scoring range: 20-100; cutoff 60 (higher scores indicate greater impairment/challenges).
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
variation in PEDSQL overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements. Scores are linearly transformed to a 0-100 scale in which high score means better condition.
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
variation in PEDSQL overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. Scores are linearly transformed to a 0-100 scale in which high score means better condition.
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
variation in CBCL overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements. Scores below the 93rd percentile is considered normal, scores between the 93-97th percentile are borderline clinical, and scores above the 97th percentile are in the clinical range.
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
variation in CBCL overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. Scores below the 93rd percentile is considered normal, scores between the 93-97th percentile are borderline clinical, and scores above the 97th percentile are in the clinical range
Measured: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Drop-out
qualitative differences between experimental and control group in drop-out per cent
Measured: measurement at end of treatment i.e approximately 24 months after baseline measurements

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 201631 Mar 2023

First posted2 Feb 2024
Study start22 Sep 2016
Primary completion31 Mar 2023
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Childhood 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06239662
Sponsor's protocol ID: GET-Obesità N.01-18/02/16
Acronym: GET-Obesity
Status last verified: Oct 2023
First submitted: 28 Dec 2023
Last updated: 1 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: We do not have the authorization to share IPD. We are in the process to agree with the Ethic Committee how the share data.

Publications

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.
PubMed 26520237
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.
PubMed 17438555
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.
PubMed 15238894
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.
PubMed 9019048
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.
PubMed 11274524
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.
PubMed 14620250
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.
PubMed 17449466
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.
PubMed 15347700
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.
PubMed 20462509
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.
PubMed 24693926
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.
PubMed 25981555
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.
PubMed 17845100
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.
PubMed 17723034
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.
PubMed 24144717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
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Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06239662
Acronym / sponsor ID: GET-Obesity / GET-Obesità N.01-18/02/16
Conditions: Childhood Obesity
Keywords: Childhood obesity, Group Intervention, Psychological Aspects
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: Azienda USL Reggio Emilia - IRCCSOther government
Study start: 22 Sep 2016 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 2 Feb 2024 (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.

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

Detailed description

The clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Therapeutic group intervention	Experimental	Behavioral: Therapeutic GroupPatients 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.
Usual care	Active comparator	Behavioral: Usual carePatients 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.

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

Degree of obesity< 95th percentile;
Organic causes of obesity;
Insufficient understanding and production of Italian language;
Age <7 or >17;
Presence of neuropsychiatric diagnosis;

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
Therapeutic GroupThe 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.	Behavioural	Therapeutic group intervention
Usual careThe dietician will meet individually each child together with parents. Dietician will provide nutritional advices.	Behavioural	Usual care

Primary outcome

BMI z-score
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
BMI z-score variation from baseline to end of treatment
BMI z-score
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
BMI z-score variation from baseline to 18 months after the and of treatment

27 secondary outcomes

healthy dietary habits
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
healthy dietary habits
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
unhealthy dietary habits
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
unhealthy dietary habits
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Insulin
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Insulin
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Drop-out
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
Background: PubMed 26520237Panebianco 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.
Background: PubMed 17438555Kalavainen 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.
Background: PubMed 15238894Zeller 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.
Background: PubMed 9019048Braet 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.
Background: PubMed 11274524French 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.
Background: PubMed 14620250Trombini 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.
Background: PubMed 17449466Goldfield 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.
Background: PubMed 15347700Braet 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.
Background: PubMed 20462509Hingle 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.
Background: PubMed 24693926Fonseca 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.
Background: PubMed 25981555Kader 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.
Background: PubMed 17845100Wilfley 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.
Individual participant dataSharing planned: Undecided. We do not have the authorization to share IPD. We are in the process to agree with the Ethic Committee how the share data.

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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.

Marta Fontana, Psycologist principal investigator

Azienda USL Reggio Emilia - IRCCS

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Group in people with Childhood Obesity, run by Azienda USL Reggio Emilia - IRCCS.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI z-score (time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements). The study lists 2 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 NCT06239662, which also lists 14 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 Apr 2024.