Family Nutrition Physical Activity Tool Use During Well Child Visits

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.

Inclusion Criteria:

- All children ages 4-17 years scheduled for well child visits

Exclusion Criteria:

-Patients with chronic medical conditions or developmental delays that preclude age
appropriate nutrition and physical activity habits will be excluded. -