Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462267
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2007-04-17
Brief Title:
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE-Garfield
Brief Summary:
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 projects active intervention arms teens primary care providers will be given customized plans describing the teens 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 teens primary care provider
Detailed Description:
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 youths 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 youths 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 eg 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
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 youths 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 youths 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None