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Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents (SHINE-Garfield)

2. april 2015 oppdatert av: Kaiser Permanente
This project will examine the effectiveness of a primary care based intervention to help overweight teen girls adopt healthy lifestyle practices. Participants will be adolescent females from Kaiser Permanente Northwest primary care clinics with a body mass index above the 90th percentile. Teens will be randomly assigned to (1) a behavioral weight control program (enriched intervention), (2) brief primary care counseling (low intensity intervention), or (3) usual-care (control). For both of the project's active intervention arms, teens' primary care providers will be given customized plans describing the teen's eating and physical activity habits and instructions on how to best work with these teens and their families. The behavioral weight control program will be specifically tailored for teen girls and will include separate group meetings for teens and parents, follow-up telephone contacts with their group leader, and coordinated feedback from the teen's primary care provider.

Studieoversikt

Status

Fullført

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:

  1. 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.
  2. 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.
  3. Adolescents in EI will report higher psychosocial functioning and quality of life outcomes than those receiving LII or Usual Care.
  4. Neither intervention will result in increases in problematic eating or weight-related behaviors or beliefs.

Studietype

Intervensjonell

Registrering (Faktiske)

215

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Oregon
      • Portland, Oregon, Forente stater, 97227
        • Kaiser Permanente Center for Health Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 15 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Lynn L DeBar, PhD, MPH, Kaiser Permanente
  • Studieleder: Michelle H Forest, PhD, Kaiser Permanente

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2005

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

17. april 2007

Først innsendt som oppfylte QC-kriteriene

17. april 2007

Først lagt ut (Anslag)

19. april 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. april 2015

Sist bekreftet

1. april 2015

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. .

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