For the Health of Our Children--Clinic Based Treatment of Childhood Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood obesity is a major public health problem in the U.S. Currently approximately one in
      three children is considered overweight or obese. Most overweight children grow to become
      overweight adults. It is unclear how effective pediatricians and other primary care
      physicians can be in assisting overweight children to normalize their body weight. Expert
      guidelines have been established, but are currently untested.

      This study will randomize overweight and obese children between the ages of 4 and 8 years old
      to either the recommended treatment guidelines or a control (non-intervention) group.

      The purpose of this study is to evaluate the ability (a) to recruit overweight children
      between the ages of 4 and 8 years old (b) to remeasure the children three months after
      enrollment and (c) to reduce childhood obesity via implementation of the recommended
      treatment guidelines.
    

Detailed description: 
      3. Research Plan:

      a. Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives
      from 16 major clinical organizations (including the PI of this proposal), published
      recommendations for primary care office-based treatment of childhood obesity. Seeking both
      clinical and cost-effectiveness, the recommendations call for staged treatment that starts
      with low intensity, and then, if unsuccessful, increases to a higher frequency of visits. The
      committee acknowledged that this staged approach "has not been evaluated." Recent reviews
      conclude that treatment of childhood obesity can be efficacious. However, most studies were
      conducted in highly controlled tertiary care research settings and involved a large number of
      direct contact hours (e.g. many with ≥ 35 contact hours). Research evaluating the translation
      of these encouraging findings into more real-world clinical settings has been lacking.
      Specifically, there is little research assessing (1) the feasibility of recruitment from
      primary care clinics or (2) whether low intensity treatment (i.e. the initial phase of the
      staged approach recommended by the expert committee) has any benefit on weight loss.

        -  Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8
           years, from a large, urban pediatric primary care clinic, randomizing them to either
           low-intensity treatment or a control group, and then re-measuring them at approximately
           3-months from the date of recruitment.

           o Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads
           and re-measure 80% at 3-months.

        -  Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score
           over a 3-month period is higher in those randomly assigned to the intervention group
           compared with those in the control group.

             -  Our hypothesis is that the intervention will result in a larger proportion of
                children decreasing BMI z-score over a 3-month period.

      Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity
      treatment of this proposal shows a trend toward improvement over usual care, this will
      justify a full scale, R01 trial testing the complete recommendations of the expert committee.
      If few subjects in the intervention group have decreasing BMI z-scores, then a smaller NIH
      trial would be needed to test an amended low-intensity treatment stage with more parent/child
      contact (e.g. emails, home visits, phone calls).
    

Intervention name(s): Behavioral counseling
Intervention type(s): Behavioral
Intervention description(s): Counseling of parents to improve their child's diet and physical activity
Other intervention name(s): Motivational Interviewing; Pediatric obesity treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Childhood obesity treatment; Motivational interviewing