- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00462267
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents (SHINE-Garfield)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97227
- Kaiser Permanente Center for Health Research
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Sædvanlig pleje
|
|
Eksperimentel: Enriched lifestyle intervention
|
Multi-component lifestyle intervention
|
Hvad måler undersøgelsen?
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
|
Kostindtag
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lynn L DeBar, PhD, MPH, Kaiser Permanente
- Studieleder: Michelle H Forest, PhD, Kaiser Permanente
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 101-9295
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