Clinical trial NCT02067728: Family Nutrition Physical Activity Tool Use During Well Child Visits
Official title: Family Nutrition, Physical Activity (FNPA) Tool: a Motivational Interviewing-based Practice Intervention to Address Pediatric Health Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity prevention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Northwestern University Feinberg School of Medicine
name: New York University
First posted: 2014-02-20
Enrollment: 430
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Percentage of Patients With Documented Goal Setting
timeFrame: 2 weeks from encounter
Secondary outcomes:
measure: Obesiogenic Goal Setting Success
timeFrame: 1 month after the encounter
measure: Obesiogenic Goal Setting Success
timeFrame: 6 months after encounter
measure: Success of Obesiogenic Goals
timeFrame: 1 month post encounter
measure: Success of Obesiogenic Goals
timeFrame: 6 months post encounter
measure: Success of Other Health Goals
timeFrame: 1 month post encounter
measure: Success of Other Health Goals
timeFrame: 6 months post encounter
measure: BMI Z-score Change for Ages 4-10 Years
timeFrame: Baseline and 6 months post encounter
measure: BMI Z-score Change for Ages 11-17 Years
timeFrame: Baseline and 6 months post encounter
Other outcomes:
measure: BMI Z-score Change for All
timeFrame: Baseline and 6 months after the encounter
measure: Perception of Patient Centeredness of Encounter
timeFrame: 1 month after the encounter
measure: Obesity Follow-up Adherence
timeFrame: 6 months after the encounter
Locations:
city: Peoria
country: United States
facility: UnityPointHealth Methodist in Peoria
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Amy Christison, MD
role: PRINCIPAL_INVESTIGATOR
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