Barriers to Treatment in Obese Adolescents
16. januar 2014 opdateret af: Virginia Commonwealth University
Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia
The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
- Participation for 6 months in a program incorporating exercise, nutritional counseling and behavioral support leads to measurable improvements in overall fitness, metabolic indicators and loss of body fat for obese adolescents.
- Degree of loss of body fat, improved overall fitness and improvements in metabolic indicators can be correlated with the degree of compliance and participation for 6 months in the program.
- Parental involvement and support can be correlated with the degree of compliance and participation in the program.
- Socioeconomic factors can be correlated with the degree of compliance and participation in the program.
- Cultural differences in diet, attitudes toward body shape, and family dynamics can be correlated with success or failure in a weight loss program.
- Individual differences in self-esteem, self-discipline and feelings of connectedness with family members can be correlated with success or failure in a weight loss program.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
292
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
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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
11 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 11-18
- Above 95th percentile for weight
- Reside within 30 miles of program site
- Ability to comprehend basic instructions
- Ability to perform basic exercise movements
Exclusion Criteria:
- Having a metabolic disorder that causes weight gain
- Having a cognitive deficit that impacts learning and comprehension
- Having a physical defect that prevents exercise
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Lifestyle Intervention
Dietary modification and exercise.
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Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.
Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.
Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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A decrease in body mass index.
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Improvement in metabolic indicators.
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Improvement in fitness measures
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Improved subject compliance with exercise and diet.
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Improved parental compliance and support.
Tidsramme: 6 months and 1 year
|
6 months and 1 year
|
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Increase knowledge of nutritional principles
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Improved attitude toward healthy behaviors
Tidsramme: 6 months and 1 year
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6 months and 1 year
|
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Increased self-esteem and motivation
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Decreased negativity
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Improved family cohesiveness
Tidsramme: 6 months and 1 year
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6 months and 1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edmond Wickham, M.D., Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ning Y, Yang S, Evans RK, Stern M, Sun S, Francis GL, Wickham EP 3rd. Changes in body anthropometry and composition in obese adolescents in a lifestyle intervention program. Eur J Nutr. 2014 Jun;53(4):1093-102. doi: 10.1007/s00394-013-0612-9. Epub 2013 Nov 10.
- Wickham EP, Stern M, Evans RK, Bryan DL, Moskowitz WB, Clore JN, Laver JH. Prevalence of the metabolic syndrome among obese adolescents enrolled in a multidisciplinary weight management program: clinical correlates and response to treatment. Metab Syndr Relat Disord. 2009 Jun;7(3):179-86. doi: 10.1089/met.2008.0038.
- Porter JS, Bean MK, Gerke CK, Stern M. Psychosocial factors and perspectives on weight gain and barriers to weight loss among adolescents enrolled in obesity treatment. J Clin Psychol Med Settings. 2010 Jun;17(2):98-102. doi: 10.1007/s10880-010-9186-3.
- Bean MK, Mazzeo SE, Stern M, Evans RK, Bryan D, Ning Y, Wickham EP 3rd, Laver J. Six-month dietary changes in ethnically diverse, obese adolescents participating in a multidisciplinary weight management program. Clin Pediatr (Phila). 2011 May;50(5):408-16. doi: 10.1177/0009922810393497. Epub 2011 Jan 10.
- Stern M, Mazzeo SE, Gerke CK, Porter JS, Bean MK, Laver JH. Gender, ethnicity, psychosocial factors, and quality of life among severely overweight, treatment-seeking adolescents. J Pediatr Psychol. 2007 Jan-Feb;32(1):90-4. doi: 10.1093/jpepsy/jsl013. Epub 2006 Jul 3.
- Stern M, Mazzeo SE, Porter J, Gerke C, Bryan D,and Laver J. Self-esteem, teasing and quality of life: African American adolescent girls participating in a family-based pediatric overweight intervention. Journal of Clinical Psychology in Medical Settings. DOI:10.1007/s10880-006-9029-4, 2006
- Browning MG, Bean MK, Wickham EP, Stern M, Evans RK. Cardiometabolic and Fitness Improvements in Obese Girls Who Either Gained or Lost Weight during Treatment. J Pediatr. 2015 Jun;166(6):1364-9. doi: 10.1016/j.jpeds.2015.03.011. Epub 2015 Apr 15.
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. november 2003
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
9. september 2005
Først indsendt, der opfyldte QC-kriterier
12. september 2005
Først opslået (Skøn)
14. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 760
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 .