Clinical trial NCT01073215: Primary Care Research Network for the Treatment of Adolescent Obesity
Official title: Primary Care Research Network for the Treatment of Adolescent Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Adolescents
Obesity
Weight Management
Family-based Lifestyle Modification
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
name: Geisinger Clinic
name: University of Pennsylvania
First posted: 2010-02-23
Enrollment: 173
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The "Primary Care Research Network for the Treatment of Adolescent Obesity" will establish infrastructure within the primary care setting to support programmatic research on weight loss for underserved adolescents, primarily urban African Americans, rural Caucasians, and Latinos. Using primary care settings, to which many youths already have entry, may increase access for underserved adolescents to participate in obesity treatment and research. The primary project will be a 12 month randomized controlled study comparing the relative effectiveness of two interventions for weight reduction: Group Condition (a family based lifestyle modification program delivered by health care providers in 23 sessions); Self-Guided Condition (a family based lifestyle modification program that combines a self-guided, home-based approach with 6 sessions delivered by health care providers).

Detailed description: The broad objective is to establish a Center of Excellence for Research on Obesity at The Children's Hospital of Philadelphia (CHOP) that will create a statewide, collaborative research network to develop and test effective treatments for reducing adolescent obesity and related medical co-morbidities in underserved populations. Collaborating institutions include Lincoln University (LU), Geisinger Health System (GHS), and the University of Pennsylvania (UPenn). Given the locations of these institutions, we will focus on urban African Americans and Latinos and rural Caucasian adolescents. The novelty of this program will be the use of a family-based, lifestyle modification program within the pediatric primary care setting with interdisciplinary teams trained to treat obese adolescents. Specific aims are to: a) design, implement, and evaluate improved treatments for obese teenagers, b) conduct focus groups and treatment development projects to better understand the needs of these populations and c) train, minority students and faculty to become healthcare research professionals. The primary research project will be a randomized clinical trial occurring at two sites: CHOP and GHS. In a four-year study, 156 adolescents (ages 12-16) will be randomized to either a one-year, 23 session, multi-family, group based Lifestyle Modification Program known as the Group Condition, or to a one-year, six-session Self-Guided Condition. Both Group and Self-Guided will be tested as possible treatment protocols for primary care pediatric practice.

The primary aim is to compare the effectiveness of these two treatments in reducing body mass index (BMI) at 12 months. Secondary aims will compare impact of the treatments on reduction of risk factors related to cardiovascular disease and diabetes, including lipids, glucose and insulin, waist circumference, blood pressure, and measures of appetite. Further, the effectiveness of these two treatments in reducing BMI at 15 and 18 months will also be analyzed. Training aims will be met through collaboration with Lincoln University to set up undergraduate summer internships, graduate assistantships, and faculty development. Other methods for achieving the objectives of the Center include: a) establishing a multidisciplinary advisory board consisting of parents, providers, and researchers; b) providing clinical training in obesity treatment for doctors, nurses, dieticians, and behavioral interventionists at our collaborating institutions (CHOP and GHS); c) making all protocols and materials culturally sensitive to the populations they serve; and d) carrying out treatment development activities to tailor the manuals for Latino youth and their families.

Eligibility criteria: Inclusion Criteria:

* Male or female adolescents
* Age 12 to 16 years
* Body Mass Index (BMI) of 28 kg/m2
* Adolescent expresses desire to lose weight
* Parent willing to participate
* Live within 40 minutes from study clinic at CHOP or 60 minutes at Geisinger

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \> 140/90 mm HG)
* Diabetes mellitus (fasting glucose \> 126 mg/dl)
* Any serious uncontrolled medical disorder that would complicate participation in a weight loss program
* Bipolar disorder or psychosis (depression ok if adolescent is receiving treatment)
* Use of any medication affecting body weight, appetite or metabolism within 30 days prior to the start of treatment
* Positive pregnancy test at medical evaluation

Primary outcomes:
measure: Percentage change in initial body mass index (BMI) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Compare mean reduction in percentage of initial BMI in the two treatments within each ethnic group/site (CHOP: urban African American adolescents and GHS: rural Caucasian adolescents
timeFrame: 12 months
measure: Compare the effectiveness of the two treatment approaches on improving risk factors for cardiovascular disease and diabetes (Total, HDL, and LDL cholesterol, triglycerides, glucose, insulin, and blood pressure) and on improving liver function
timeFrame: 12 months
measure: Compare mean reduction in percentage of initial BMI in each treatment group at month 6
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia and University of Pennsylvania
name: Robert I Berkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: