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Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents (SHINE)
This study has been completed.
Sponsors and Collaborators: Kaiser Permanente
Garfield Memorial Fund
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00462267
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Enriched lifestyle intervention
Behavioral: Low-intensity lifestyle intervention

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Body mass index

Secondary Outcome Measures:
  • Quality of life (PedsQL 4.0)
  • Self esteem (RSE)
  • Depression (PHQ-A)
  • Unhealthy eating practices (QEWPR-A, TFEQ)
  • Weight and shape concerns (WCS)
  • Sociocultural attitudes toward appearance (SATAQ)
  • Participant satisfaction with the intervention
  • Dietary intake
  • Personal and family eating patterns
  • Physical activity
  • Sedentary behaviors
  • Personal and family physical activity patterns

Estimated Enrollment: 65
Study Start Date: January 2005
Study Completion Date: October 2006
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 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.
  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462267

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Garfield Memorial Fund
Investigators
Principal Investigator: Lynn L DeBar, PhD, MPH Kaiser Permanente
Study Director: Michelle H Forest, PhD Kaiser Permanente
  More Information

Study ID Numbers: 101-9295
Study First Received: April 17, 2007
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00462267  
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Nutrition
Exercise
Body mass index
Lifestyle change
Obesity
Overweight
Adolescents
Teens

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009