Primary Care Treatment for Overweight Adolescent Females (SHINE)
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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:

      Determine if dietary intake (total energy intake, % calories from fat, etc.) and/or physical
      activity mediate the effect of the intervention on BMI z score. H2: Change in dietary intake
      and physical activity from baseline to 6 months will mediate the relationship between the
      intervention and change in BMI z score from baseline to 12 months.

      Determine the impact of the experimental intervention for overweight adolescents and their
      families on the secondary outcomes including other physiological parameters (triglycerides,
      cholesterol, fasting insulin), quality of life, and psychosocial functioning; participant
      safety (depression and disordered eating behaviors); and feasibility/acceptability of the
      intervention (e.g., participant and provider satisfaction) in preparation for future Phase
      III trials.

      Determine the incremental cost-effectiveness of the intervention relative to usual care from
      the societal perspective. We will examine the direct cost of delivering the intervention and
      this treatment's impact on subsequent use and cost of health services. We also will include
      indirect costs to participants and their families due to their participation in the
      intervention and use of other health care services (e.g., time spent in travel, usual care
      visits, out-of session activities).
    

Intervention name(s): Healthy lifestyle managment
Intervention type(s): Behavioral
Intervention description(s): Exercise, yoga, food diaries, provider consultation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Teen girls; weightloss; healthy lifestyle; yoga; Weight loss and healthy lifestyle