Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Peer Counseling in Family-Based Treatment for Childhood Obesity (EPICH)

19. maj 2015 opdateret af: Brian Saelens, Seattle Children's Hospital
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The current study seeks to test the alternative approach of partnering with families, and more specifically parents who have previously received family-based weight control treatment, to serve as peer interventionists to deliver this treatment to other families. Peer-led interventions, common for other health behaviors among adults, has not been previously developed or tested for family-based pediatric weight control intervention. Peer-delivered interventions considerably reduce the high costs of delivering behavioral interventions and could increase the availability of those able to deliver the intervention. In fact, peer interventionists' may be better able to deliver intervention than professionals to families, given these peers have faced similar challenges and barriers to behavior change within their own families. It is also possible that continued engagement in the behavior change process through delivering this intervention to other families could improve peer interventionists' own family's long-term health behaviors and outcomes.

Before utilizing a peer delivery approach more broadly, the novel approach of peer-delivered intervention requires development of training/supervision for peer interventionists and initial evaluation of acceptability/feasibility and efficacy. Therefore, this project has the following aims:

  1. To develop procedures for training and supervising of parents to be peer interventionists, based on our prior intervention delivery experience and family advisory board input
  2. To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention
  3. To compare change in weight and health behavior outcomes of overweight/obese children and parents receiving peer- versus professionally-delivered intervention

This study begins to address the high cost and limited availability of the needed, but intense, family-based pediatric weight control intervention required for efficacy. This approach expands the interdisciplinary nature of this work by engaging the resources and assets of previously treated families to contribute to the reduction of the burden of childhood obesity. Led by a project director (Saelens) and intervention coordinator (Scholz) with over 20 years of combined experience in family-based pediatric weight control intervention, this project moves this intervention in a different and important direction.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98121
        • Seattle Children's

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 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Child age: 7-11 years at time of enrollment
  • Overweight child: at or above 85th percentile for age- and gender-specific BMI.
  • At least one overweight parent (BMI≥ 25.0).
  • Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
  • Must live within 50 miles of the treatment center.

Exclusion Criteria:

  • Current enrollment in another weight control program for the participating child or parent.
  • The participating parent is pregnant.
  • Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
  • Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
  • Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
  • Medication regimen for the child that affects his or her weight.
  • Conditions known to promote obesity in the participating child (e.g. Prader-Willi).
  • Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.

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
Eksperimentel: Peer Interventionist
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Adfærdsmæssigt: Family-based behavioral intervention
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Aktiv komparator: Professional Interventionist
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Adfærdsmæssigt: Family-based behavioral intervention
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Child BMI z-score
Tidsramme: 20 weeks
20 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability
Tidsramme: 20 weeks
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
20 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Seattle Children's Hospital

Efterforskere

  • Ledende efterforsker: Brian E. Saelens, PhD, Seattle Children's

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. september 2012

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

12. december 2012

Først indsendt, der opfyldte QC-kriterier

8. februar 2013

Først opslået (Skøn)

12. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SafewayFoundationSaelens-01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Fedme hos børn

Kliniske forsøg med Family-based behavioral intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner