Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Garfield Memorial Fund
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00462267
First received: April 17, 2007
Last updated: March 23, 2010
Last verified: March 2010
  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 Phase
Obesity
Overweight
Behavioral: Usual care control group
Behavioral: Enriched lifestyle intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • BMI z-score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (PedsQL 4.0) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Self esteem (RSE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Depression (PHQ-A) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Unhealthy eating practices (QEWPR-A, TFEQ) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Weight and shape concerns (WCS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Sociocultural attitudes toward appearance (SATAQ) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Participant satisfaction with the intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Personal and family eating patterns [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Sedentary behaviors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Personal and family physical activity patterns [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care Behavioral: Usual care control group
Usual care
Experimental: Enriched lifestyle intervention Behavioral: Enriched lifestyle intervention
Multi-component lifestyle intervention

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Victor J. Stevens, PhD, Senior Investigator, Kaiser Permanente Center for Health Research
ClinicalTrials.gov Identifier: NCT00462267     History of Changes
Other Study ID Numbers: 101-9295
Study First Received: April 17, 2007
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014