Family Nutrition Physical Activity Tool Use During Well Child Visits
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The main aim of the study would be to examine the effect of using a health behavior screening
      tool and a brief patient centered conversation on health behavior goal setting during
      well-child visits.
    

Detailed description: 
      Rationale and Significance: Although much research aimed at preventing childhood obesity
      focuses on community, environment, and school-based initiatives, there is significant
      potential for healthcare systems and primary care providers to aid in preventing obesity. All
      children, one-third of whom are overweight, have multiple well-child and acute encounters
      with their providers. Provider counseling regarding Body Mass Index (BMI) is strongly
      correlated with a parent's perception of his or her child's weight, and parents who perceive
      BMI as a health problem are 10 times more likely to make healthy lifestyle changes.As a
      result, a practice intervention aimed at improving behavior change goals employed during
      well-child encounters provide an optimal opportunity for physicians to impact family
      lifestyle behaviors and hopefully reduce the trajectory of obesity rates in their patient
      population.

      To our knowledge, there is little published evidence regarding the use of validated, brief,
      screening and coaching tools paired with MI-enhanced conversations related to obesigenic
      behaviors during health supervision visits. The proposed project, a practice-based
      intervention that pairs Brief Action Planning (BAP)focused on targeted obesigenic behaviors
      identified by the Family Nutrition Physical Activity (FNPA ) tool, addresses many of the
      barriers of existing current practice approaches and will enable providers to implement a
      focused conversation to establish realistic behavior change goals. The study brings primary
      care providers to the forefront of obesity prevention while allowing the patient to direct
      the path to behavior change. The intervention includes a patient-centered approach and has
      been proven to be feasible and acceptable among providers and patients. The potential impact
      of this project is to increase provider and patient collaboration for goal-setting, which
      will then result in a reduction of obesigenic behaviors. Evidence from this investigation
      will give providers specific and feasible methods for counseling on behaviors associated with
      obesity.

      Procedures:

      Practice Recruitment: For 3 months, practice recruitment meetings will be held with offices
      from three healthcare networks during which the research protocol will be explained, roles
      and responsibilities of research staff and practices will be outlined, and written agreements
      signed. At baseline, all practices will complete a practice and provider demographic
      questionnaire to characterize any baseline procedures and documentation practices related to
      obesity prevention as well as previous provider training in obesity prevention and MI
      (questionnaire is available on request). Practices will then be matched and randomly
      assigned.

      Practice training: Practitioners will have a four-month period to undergo three 1.5-hour
      training sessions to learn the principles of MI and BAP and get familiar with using the FNPA
      tool. Research staff and trainers who are licensed clinical professional counselors (LCPC)
      certified in BAP will lead trainings. A PhD psychologist researcher will develop the
      curriculum and oversee trainers. Competency will be measured by successful certification of a
      BAP encounter and correctly interpreting three FNPA tools. Trained research staff will teach
      office staff correct techniques in anthropometrics and FNPA scoring. Competency will be
      measured by three accurate measurements and correct scoring of three FNPA tools. Scales and
      stadiometers at each enrolled practice will be calibrated for consistency in measurement
      across sites.

      Subject Recruitment: Subject recruitment will occur one month before implementation. Eligible
      subjects with scheduled well-child visits will receive a letter signed by their provider and
      the PI (Amy Christison, MD). The letter will briefly describe the study and offer the
      opportunity to enroll. They will be given an opt-out phone number to call within one week of
      mailing this letter if they do not want to participate. If the research coordinator does not
      receive a call, he/she will contact the family by phone to answer questions and send a
      consent form to the family. The subject will be considered enrolled after obtaining a signed
      written consent from the family.

      Implementation Period: The FNPA tool will be routinely used during all health supervision
      visits in the implementation practices during 6 months, regardless of patient is enrolled or
      not. During scheduled well child visits, treatment group practices will implement the FNPA
      tool using BAP. Parents/guardians of all patients, ages 4 to 11, will be asked to answer the
      FNPA child questionnaire, and patients, ages 12 to 17, with their parents will answer the
      FNPA adolescent questionnaire. The practice staff will score it, and providers will 1) engage
      the family in a patient-centered discussion about the patient's body mass index (BMI)
      percentage ,2) discuss healthy and obesigenic behaviors identified on the tool, 3) mutually
      decide on any goals for change, 4) determine the patient's confidence for change, and 5)
      offer follow-up by phone or appointment regarding stated goals, and 6) offer follow-up
      appointments for focused counseling of patients identified as overweight or obese as per
      American Academy of Pediatrics (AAP) recommendations. Goals and follow-up plans will be
      documented on the FNPA tool, and copies will be given to the family and retained in the
      chart. For healthy weight children, if follow-up by phone call is chosen, it will be
      implemented at the time selected by the patient and by the clinical research staff trained in
      BAP so that lack of support staff in a particular site for such calls is not a confounding
      variable.

      Control group practices will provide usual well-child care per AAP recommendations.Their
      patients will complete an FNPA assessment questionnaire directly after their appointment for
      the purposes of comparing baseline and end point measures. Importantly, this approach
      prevents the possibility of providers commenting on the results.

      Both treatment and control group parents/guardians of patients attending appointments will
      provide demographic data including parent-reported parent weight and height, and income
      range. Age, sex, and patient calculated BMI and z-score will be abstracted from the medical
      record.

      Outcomes Measurement Procedures:

        1. Treatment group patients will rate their impressions of the FNPA tool at the end of the
           appointment. If patients are adolescents (12 years or older), both the patient and the
           attending parent will complete the survey. Parents of younger children will complete
           surveys for those patients.

        2. A research assistant blinded to treatment group will perform all phone surveys. At 1
           month, patients from both groups will be will be asked to rate how patient centered
           their encounter was. Behavior change surveys will be performed at 1 month and 6 months
           following the encounter.

        3. All subjects will be asked to return to their practices for weight and height
           measurements 6 months after their initial encounter and to fill out a second FNPA tool.
           This will be performed by un-blinded research staff as using blinding in this setting
           would not be feasible.

        4. Audit of charting regarding goal setting documentation, successful identification of
           overweight and obese patients, and compliance with recommended follow-up appointments
           will be performed of both groups.

        5. Treatment group providers will have a baseline and two random encounters audio recorded
           midway and at the end of the intervention period. They will be scored for fidelity to
           the BAP-approach by a trained and blinded coder. This is done to understand the
           effectiveness of the BAP training for the provider. They will also receive feedback from
           the coding results and given a refresher if needed. Control group providers will have
           one baseline encounter recorded and scored for fidelity and comparison to treatment
           group providers.

        6. Providers will be surveyed regarding their satisfaction with the FNPA intervention at
           the end of the 6-month intervention time.

      Analysis: Analysis will be done with Statistical Analysis System (SAS) 9.3 or the latest
      version. A significance level of p<=0.05 is accepted as significant. Descriptive statistics
      (mean, median, mode, range) will be examined and the data set cleaned. To compare the two
      study groups for univariate analysis, t-tests will be computed for interval variables,
      Mann-Whitney U for ordinal variables, and Chi-square for nominal variables. Generalized
      Linear Mixed Models will be employed for multivariate analysis with repeated measures and
      multi-level effects. Subjects who drop out or are lost to follow-up will be compared to
      completed subjects in differences related to demographics, socioeconomic status, and BMI.
    

Intervention name(s): FNPA tool; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits.; Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity prevention