- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00461994
The Role of Exercise and Diet in Weight Loss in Obese Children
The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.
Objectives:
- The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
Secondary goals were:
- To determine the effects of exercise and/or diet on body composition.
- To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
- To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
- To determine the role of exercise and/or diet on psychological parameters of obese children.
Study Population
Inclusion Criteria
- Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Exclusion Criteria
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of three groups.
The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
On the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:
Weight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.
Safety:There were no complications with these modes of treatment.
Tipo di studio
Iscrizione
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beer-Sheva, Israele
- Soroka Medical Center
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Petah-Tikva, Israele, 49202
- Schneider Children's Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Exclusion Criteria:
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Indice di massa corporea
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BMI-SDS
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BODY FAT PERCENTAGE
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WAIST AND HIP CIRCUMFERENCES
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Misure di risultato secondarie
Misura del risultato |
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BLOOD METABOLIC PROFILE
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BLOOD INFLAMATORY MARKERS
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GHRELIN AND LEPTIN LEVELS
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RESTING ENERGY EXPENDITURE
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PSYCHOLOGICAL PARAMETERS
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Moshe Phillip, Prof, MD, Schneider Children Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- rmc003189CTil
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .