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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enriched lifestyle intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Nutrition, Exercise, Body mass index, Lifestyle change, Obesity, Overweight, Adolescents, Teens

Eligibility Criteria

13 Years - 15 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kaiser Permanente Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Enriched lifestyle intervention

Arm Description

Outcomes

Primary Outcome Measures

BMI z-score

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

Full Information

First Posted
April 17, 2007
Last Updated
April 2, 2015
Sponsor
Kaiser Permanente
Collaborators
Garfield Memorial Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00462267
Brief Title
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents
Acronym
SHINE-Garfield
Official Title
Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Garfield Memorial Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Nutrition, Exercise, Body mass index, Lifestyle change, Obesity, Overweight, Adolescents, Teens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Enriched lifestyle intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Enriched lifestyle intervention
Intervention Description
Multi-component lifestyle intervention
Primary Outcome Measure Information:
Title
BMI z-score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life (PedsQL 4.0)
Time Frame
2 years
Title
Self esteem (RSE)
Time Frame
2 years
Title
Depression (PHQ-A)
Time Frame
2 years
Title
Unhealthy eating practices (QEWPR-A, TFEQ)
Time Frame
2 years
Title
Weight and shape concerns (WCS)
Time Frame
2 years
Title
Sociocultural attitudes toward appearance (SATAQ)
Time Frame
2 years
Title
Participant satisfaction with the intervention
Time Frame
2 years
Title
Dietary intake
Time Frame
2 years
Title
Personal and family eating patterns
Time Frame
2 years
Title
Physical activity
Time Frame
2 years
Title
Sedentary behaviors
Time Frame
2 years
Title
Personal and family physical activity patterns
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn L DeBar, PhD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle H Forest, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

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