Primary Care Research Network for the Treatment of Adolescent Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Family-Based Lifestyle Modification; Family-Based Lifestyle Modification Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Self-Guided condition will receive the same manual content and recommendations for eating and physical activity as the Group Condition. Since this approach is primarily home-based, participants in this condition will also receive additional tips and guidelines to assist the family in following the program at home. There will be 6 visits with the health coach at weeks 01, 04, 08, 24, 40, and 52. Participants will receive 2 phone calls from health coach at weeks 16 and 32. Parents and teens will be encouraged to hold weekly meetings at home to discuss program goals and progress.; The Group condition will consist of a comprehensive family based lifestyle modification program of 23 visits (8 weekly, 8 bi-weekly, 7 monthly).
Intervention visits include a combination of 17 group sessions and 6 individual meetings with health coach. There will be 7 phone calls two weeks after each monthly visit. Adolescents and their parents attend concurrent group meetings. The content of the sessions will include topics related to nutrition, physical activity, and behavior modification for weight management.
Other intervention name(s): TEENS Study; TEENS Study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Obesity; Weight Management; Family-based Lifestyle Modification