- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00462267
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents (SHINE-Garfield)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Overweight / obesity among youth has recently been declared a "public health crisis" in the United States and other Western countries due to its alarming increase in prevalence (Flegal, 1999; Kohn & Booth, 2003; Lobstein et al., 2004; Sokol, 2000). Over the past decade, overweight in youth (Body mass index [BMI] > 95th percentile) has increased 4% for school-age children, 6 - 11 years old. Adolescents, 12 - 19 years of age are even more overweight (5%) (Ogden et al., 2002). Further, American adolescents had the highest prevalence of overweight among 15 western countries included in a cross-sectional, nationally representative school-based study (Lissau et al., 2004). Such trends are particularly troubling given the psychosocial and physical health risks associated with being overweight in childhood (Must & Strauss, 1999). Overweight among youth appears to confer longer-term health risks even among later normative weight adults (Must et al., 1992). Further, both longer-term health risks and the probability of adult obesity is greater for overweight adolescents than for those developing weight problems earlier in childhood (Must et al., 1992; Whitaker et al., 1997). Collectively, these factors suggest adolescent weight control is an important public health priority.
Clinic-based weight control treatments for youth have demonstrated some success, however, most empirically-supported interventions have been designed for younger school-age children and their families (see Epstein et al., 1998 for a review). Even though a large volume of research explores adult-weight control (see NIH-NHLBI, 1998 for a review) and (though more limited) substantial research examines childhood obesity (see Epstein et al., 1998 for a review), obesity treatments for adolescents have not been adequately studied. Furthermore, almost all empirically tested weight control interventions among youth have been based in academic research clinics rather than the primary care medical settings, in which weight problems among these youth are most often identified and, arguably, in which they could be most efficiently treated. Placing adolescent weight-related interventions within primary medical care settings could make such interventions both more cost-effective and easier to disseminate. The purpose of this study is to assess the feasibility, acceptability, relative cost, and efficacy of a collaborative primary care-based behavioral lifestyle intervention (Enriched Intervention - EI) for overweight adolescent females and their families. This multi-component intervention, adapted for gender and developmental stage, will include a combination of assessment, group teen and parent sessions, individual telephone-based coaching contact, and a distinct collaborative care component with follow-up visits to the youth's primary care provider [PCP]. Further, we will compare the EI to a low intensity intervention [LII] (assessment and information about healthy diet and activity, and follow-up visits with the youth's PCP) and a usual care control condition.
We hypothesize that:
- Adolescents participating in the Enriched Intervention (EI) will have a greater decrease in BMI percentile scores than adolescents receiving the Low Intensity Intervention (LII) or Usual Care.
- Adolescent in EI will have improved healthy lifestyle skills (e.g., more physical activity, less junk food and sodas) compared with those receiving LII or Usual Care.
- Adolescents in EI will report higher psychosocial functioning and quality of life outcomes than those receiving LII or Usual Care.
- Neither intervention will result in increases in problematic eating or weight-related behaviors or beliefs.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97227
- Kaiser Permanente Center for Health Research
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Body mass index 90th percentile or greater
- One or both parent(s) willing to participate in study assessments and parent sessions
Exclusion Criteria:
- Body mass index 99th percentile or greater
- Significant cognitive impairment
- Current pregnancy
- Congenital heart disease that limits activity
- Serious asthma requiring oral prednisone
- Taking medications that increase appetite
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Vanlig omsorg
|
|
Eksperimentell: Enriched lifestyle intervention
|
Multi-component lifestyle intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
BMI z-score
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Quality of life (PedsQL 4.0)
Tidsramme: 2 years
|
2 years
|
Self esteem (RSE)
Tidsramme: 2 years
|
2 years
|
Depression (PHQ-A)
Tidsramme: 2 years
|
2 years
|
Unhealthy eating practices (QEWPR-A, TFEQ)
Tidsramme: 2 years
|
2 years
|
Weight and shape concerns (WCS)
Tidsramme: 2 years
|
2 years
|
Sociocultural attitudes toward appearance (SATAQ)
Tidsramme: 2 years
|
2 years
|
Participant satisfaction with the intervention
Tidsramme: 2 years
|
2 years
|
Diettinntak
Tidsramme: 2 år
|
2 år
|
Personal and family eating patterns
Tidsramme: 2 years
|
2 years
|
Physical activity
Tidsramme: 2 years
|
2 years
|
Sedentary behaviors
Tidsramme: 2 years
|
2 years
|
Personal and family physical activity patterns
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lynn L DeBar, PhD, MPH, Kaiser Permanente
- Studieleder: Michelle H Forest, PhD, Kaiser Permanente
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 101-9295
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Enriched lifestyle intervention
-
The University of Texas Health Science Center,...EurofinsFullførtOdontogen Deep Space Neck InfeksjonForente stater
-
University of PittsburghUnited States Department of DefenseFullførtSmerte | AmputasjonsstubberForente stater
-
University of Alabama at BirminghamUnited States Department of DefenseFullførtTraumatisk hjerneskadeForente stater
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th... og andre samarbeidspartnereRekrutteringSmerte i korsryggen | Kronisk smerte | Kirurgi | Ryggsmerter Nedre rygg Kronisk | Ryggsmerter, lavForente stater
-
Case Western Reserve UniversityAmerican UniversityHar ikke rekruttert ennåErnæring, sunn
-
Thomas Jefferson UniversityRekrutteringProstata karsinomForente stater
-
Tel Aviv UniversityFullført
-
National Institute of Allergy and Infectious Diseases...FullførtKronisk granulomatøs sykdomForente stater
-
Oregon Research InstituteFullført
-
Sarah BlaylockVA Office of Research and DevelopmentFullførtFalle | LavsynForente stater