Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
2. november 2012 opdateret af: University of Kansas
Effectiveness of a Treatment Program for Pediatric Obesity
The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families.
The target intervention was compared to an enhanced standard of care treatment.
The impact of both treatment programs on numerous outcomes was explored.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings.
A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families.
As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL).
Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention.
Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
93
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
-
Lawrence, Kansas, Forenede Stater, 66045
- University of Kansas
-
-
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
7 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Child between ages 7 and 17 (inclusive)
- Child BMI at or above the 85th percentile based on norms provided for age and gender
- Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
- Child's parent/caregiver is willing to participate with the child in the program
Exclusion Criteria:
- Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
- Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence
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)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Brief Family Intervention (Primarily education)
Behaviorally based family group intervention using standard education and nutrition counseling.
Three hours of client contact
|
3 hours of contact with registered dietician for education and nutritional counseling.
|
|
Eksperimentel: Positively Fit
12 week (90 minute per session) behavioral group intervention for children and their parents.
Children and parent attend parallel group with identical (but developmentally appropriate) information presented.
|
12-week group intervention for children with obesity and their parents/caregivers
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
BMI Percentile Change
Tidsramme: Treatment completion, 1 year follow up
|
Treatment completion, 1 year follow up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
Tidsramme: treatment completion, one year follow up
|
treatment completion, one year follow up
|
|
Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002)
Tidsramme: Treatment completion, one year follow up
|
Treatment completion, one year follow up
|
|
Cost-effectiveness
Tidsramme: Treatment completion, one year follow up
|
Treatment completion, one year follow up
|
|
Consumer Satisfaction
Tidsramme: Treatment completion
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Treatment completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ric G Steele, Ph.D., University of Kansas
- Ledende efterforsker: Ann M. Davis, Ph.D., University of Kansas Medical Center
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.
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. juli 2006
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. maj 2010
Datoer for studieregistrering
Først indsendt
17. august 2006
Først indsendt, der opfyldte QC-kriterier
17. august 2006
Først opslået (Skøn)
18. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R40MC06631-01-00
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 .