Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents

Obesity Clinical Trial

— SHINE-Garfield  

Official title:

Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462267
• Other study ID #: 101-9295
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2007
• Last updated: April 2, 2015
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Enriched lifestyle intervention
Multi-component lifestyle intervention

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Garfield Memorial Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score		2 years	No
Secondary	Quality of life (PedsQL 4.0)		2 years	No
Secondary	Self esteem (RSE)		2 years	No
Secondary	Depression (PHQ-A)		2 years	No
Secondary	Unhealthy eating practices (QEWPR-A, TFEQ)		2 years	No
Secondary	Weight and shape concerns (WCS)		2 years	No
Secondary	Sociocultural attitudes toward appearance (SATAQ)		2 years	No
Secondary	Participant satisfaction with the intervention		2 years	No
Secondary	Dietary intake		2 years	No
Secondary	Personal and family eating patterns		2 years	No
Secondary	Physical activity		2 years	No
Secondary	Sedentary behaviors		2 years	No
Secondary	Personal and family physical activity patterns		2 years	No