Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Kaiser Permanente Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
---|---|
Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00451685 |
This project will examine the effectiveness of a primary care based intervention to help overweight teen girls adopt healthy lifestyle practices. Participants are adolescent females at select 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), (or 2) usual-care (control). Primary care providers of teens in the intervention condition are 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 is specifically tailored for teen girls and includes 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: Lifestyle Change |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Primary Care Treatment for Overweight Adolescent Females |
Enrollment: | 215 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | May 2009 |
Arms | Assigned Interventions |
---|---|
Lifestyle Change: Experimental |
Behavioral: Lifestyle Change
16 group sessions for teens, 12 sessions for parents, covering nutrition, exercise, body image, self-esteem, etc. Also includes periodic coaching calls during follow-up period.
|
Usual Care: No Intervention
Psychoeducational materials and usual care from medical provider.
|
Obesity is currently a major US public health problem, given its prevalence and adverse health consequences. In the past two decades, the percentage of overweight adolescents has almost tripled from 5 to 14%. Clinic-based weight control treatments for youth have demonstrated some success, but most have been designed for pre-adolescent children and their families. Even though considerable research explores adult-weight control and a growing body of research examines childhood obesity, treatments for adolescents have not been adequately studied. Also, almost all empirically tested interventions for youth have been based in academic research clinics rather than in primary care medical settings, where weight problems are most often identified and may be most efficiently treated. Placing adolescent weight-related interventions in primary medical care settings could make them both more easily disseminated and more cost-effective. Finally, treating obesity in a primary care (non-school) setting may be particularly effective/appropriate for teen girls for two reasons. First, overweight girls are at higher risk than normal-weight peers for engaging in unhealthy weight-control behaviors. Second, researchers speculate that teen girls' self-consciousness in mixed-gender physical education (PE) classes may contribute to their lower enrollment rates enrollment in PE classes and overall decline in physical activity in recent years. If so, targeting physical activity in a primary-care-based program may be more successful than in school-based programs.
We propose to examine the clinical effectiveness and incremental cost-effectiveness of a primary care-based multi-component lifestyle intervention for overweight adolescent females and their families. This multi-component intervention will be tailored for gender and developmental stage, and will include a behaviorally-based intervention for teens and parents as well as coordinated feedback and counseling from the adolescent's pediatric primary care provider (PCP). We will compare the primary care-based intervention to a usual-care control condition in which adolescents and their family receive information about weight loss and guidelines for achieving and maintaining a healthy lifestyle along with the encouragement to utilize any appropriate health care services.
The principal aim of the study is to determine the clinical effectiveness of a primary care-based, multi-component lifestyle intervention for overweight (≥ 90th percentile) adolescent females and their families. H1: We hypothesize that the treatment group will have a greater decrease in BMI z-score from baseline to 12 months than the control youth.
In addition, we include the following secondary aims that are exploratory and intended to be hypothesis-generating rather than hypothesis-testing activities:
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Oregon | |
Kaiser Permanente Center for Health Research | |
Portland, Oregon, United States, 97227 |
Principal Investigator: | Victor J Stevens, PhD | Kaiser Permanente |
Study ID Numbers: | R01 HD050931-01 |
Study First Received: | March 21, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00451685 |
Health Authority: | United States: Institutional Review Board |
Nutrition Exercise Body mass index Lifestyle change |
Obesity Overweight Adolescents Teens |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |