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The Role of Exercise and Diet in Weight Loss in Obese Children

17. april 2007 opdateret af: Rabin Medical Center

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.

Studieoversigt

Detaljeret beskrivelse

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:

  1. The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
  2. Secondary goals were:

    1. To determine the effects of exercise and/or diet on body composition.
    2. To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
    3. 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.
    4. To determine the role of exercise and/or diet on psychological parameters of obese children.

Study Population

Inclusion Criteria

  1. Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
  2. A signed informed consent will be taken from patients and their parents.
  3. Agreement to a follow-up of one year.

Exclusion Criteria

  1. Cardiac problems (arrhythmia, Congestive heart disease)
  2. Uncontrolled hypertension
  3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
  4. Renal failure
  5. Genetic syndromes associated with obesity
  6. Presence of untreated hypothyroidism
  7. 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.

Undersøgelsestype

Interventionel

Tilmelding

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Beer-Sheva, Israel
        • Soroka Medical Center
      • Petah-Tikva, Israel, 49202
        • Schneider Children's Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 11 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
  2. A signed informed consent will be taken from patients and their parents.
  3. Agreement to a follow-up of one year.

Exclusion Criteria:

  1. Cardiac problems (arrhythmia, Congestive heart disease)
  2. Uncontrolled hypertension
  3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
  4. Renal failure
  5. Genetic syndromes associated with obesity
  6. Presence of untreated hypothyroidism
  7. Participation in a clinical study during the last month

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES

Sekundære resultatmål

Resultatmål
BLOOD METABOLIC PROFILE
BLOOD INFLAMATORY MARKERS
GHRELIN AND LEPTIN LEVELS
RESTING ENERGY EXPENDITURE
PSYCHOLOGICAL PARAMETERS

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Moshe Phillip, Prof, MD, Schneider Children Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2004

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

17. april 2007

Først indsendt, der opfyldte QC-kriterier

17. april 2007

Først opslået (Skøn)

18. april 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. april 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2007

Sidst verificeret

1. april 2007

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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