- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01789671
Peer Counseling in Family-Based Treatment for Childhood Obesity (EPICH)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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:
- 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
- To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention
- 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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Washington
-
Seattle, Washington, Spojené státy, 98121
- Seattle Children's
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
|
|
Aktivní komparátor: 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.
|
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Child BMI z-score
Časové okno: 20 weeks
|
20 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acceptability
Časové okno: 20 weeks
|
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
|
20 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Brian E. Saelens, PhD, Seattle Children's
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SafewayFoundationSaelens-01
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Dětská obezita
-
Children's Hospital of Fudan UniversityAktivní, ne náborVŠECHNY, Childhood B-CellČína
-
University Hospital TuebingenNáborVŠECHNY, Childhood B-Cell | Relaps akutní lymfoidní leukémie | Refrakterní akutní lymfocytární leukémieNěmecko
Klinické studie na Family-based behavioral intervention
-
Sarah MorrowLawson Health Research InstituteDokončeno
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brown... a další spolupracovníciNábor
-
Queen's UniversityCanadian Institutes of Health Research (CIHR)Dokončeno
-
Fenway Community HealthNational Institute of Mental Health (NIMH)DokončenoHIV infekceSpojené státy
-
Network for Engineering and Economics Research...DokončenoAntikoncepce | Těhotenská anémie z nedostatku železa | Předporodní péče | Poporodní péčeIndie
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)DokončenoObezita | Nadváha | Ztráta váhy | Zdravotní chováníSpojené státy
-
Rutgers, The State University of New JerseyAutism SpeaksNáborAgrese | Problémové chování | SebezraněníSpojené státy