Brief Motivational Interviewing to Reduce Child Body Mass Index
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children.
      Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three
      groups. The first group continued with standard care; in group 2, each practitioner delivered
      four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in
      addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing
      visits. The primary outcome will be the child's percentile BMI change between the baseline
      and 2-year follow-up. Secondary outcomes will include behavior change around fruits and
      vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger
      decrease in BMI percentile for children in group 3 than in group 2, and that children in
      group 2 will have a decrease in BMI percentile when compared to group one.
    

Detailed description: 
      The study is a cluster-randomized intervention trial with clinical practices serving as the
      unit of randomization and analysis. The investigators are testing two increasingly intensive
      interventions compared to a minimal intensity/Usual Care Group. Group 1 (Usual Care) includes
      determination of BMI percentile at baseline, 1-year, and 2-year follow-up. Usual Care (UC)
      practitioners provide parents with educational materials and routine care. UC pediatricians
      and their study staff received a ½ day study orientation session which included a brief
      CME-type workshop addressing obesity treatment.. Group 2 (Pediatric Practitioner only)
      includes the same assessment points as UC. In addition, Group 2 Pediatric Practitioners (PPs)
      received 2 days of in-person training in Motivational Interviewing (MI) and Behavior Therapy
      (BT) as well as an interactive DVD MI booster training system focusing on pediatric obesity.
      PPs in Group 2 are asked to schedule 3 proactive counseling sessions with a parent of the
      index child in Year 1 and one additional "booster" visit in year 2. To guide their counseling
      they are provided with a food and activity screening tool. In addition, Group 2 practices are
      provided with educational materials written in a style consistent with Motivational
      Interviewing and Self Determination Theory. Unlike in Group 1, where all of the educational
      materials are provided proactively to each parent, in Groups 2 and 3, materials are
      distributed on a more selective tailored basis depending on parent needs. Group 3 (PP+RD)
      includes the same intervention components as Group 2, but adds MI-based counseling from a
      trained and registered dietitian (RD) who is linked to that practice. RDs deliver 6 MI-based
      counseling sessions over 2 years. The intervention is front loaded with 4 sessions in Year 1
      and the remaining 2 in Year 2. The RD sessions are delivered both in-person (required for
      visit 1) and optionally by telephone or in-person, subsequently. Similar to MDs, RDs received
      2.0 days of in-person MI and BT training, and the interactive DVD MI booster training system.
    

Intervention name(s): Standard Care; Moderate Dose Motivational Interviewing; Higher Dose Motivational Interviewing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment; Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment; Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric Obesity; Motivational Interviewing; Overweight; Behavior Change