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Family Nutrition Physical Activity Tool Use During Well Child Visits

Family Nutrition, Physical Activity (FNPA) Tool: a Motivational Interviewing-based Practice Intervention to Address Pediatric Health Behaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067728
Acronym
FNPA
Enrollment
430
Registered
2014-02-20
Start date
2014-02-28
Completion date
2015-04-30
Last updated
2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity 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.

Interventions

BEHAVIORALFNPA tool

Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits.

BEHAVIORALUsual Care

Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Northwestern University Feinberg School of Medicine
CollaboratorOTHER
New York University
CollaboratorOTHER
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes

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. -

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients With Documented Goal Setting2 weeks from encounterHealth behavior change goal documented in charting of well-child visits.

Secondary

MeasureTime frameDescription
Success of Obesiogenic Goals1 month post encounterDegree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.
Success of Other Health Goals1 month post encounterDegree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.
BMI Z-score Change for Ages 4-10 YearsBaseline and 6 months post encounter
BMI Z-score Change for Ages 11-17 YearsBaseline and 6 months post encounter
Obesiogenic Goal Setting Success1 month after the encounterDegree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.

Other

MeasureTime frameDescription
Obesity Follow-up Adherence6 months after the encounterSubjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter
BMI Z-score Change for AllBaseline and 6 months after the encounterAnthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.
Perception of Patient Centeredness of Encounter1 month after the encounterPatient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot

Countries

United States

Participant flow

Recruitment details

This was a randomized controlled trial comprised of 12 primary care clinics within the Peoria, Illinois region, providing well-child care to children ages 4-17 years. Clinics were a combination of pediatric, medicine/pediatric, and family medicine clinics. Study group assignments were determined by size, specialty, and socioeconomic demographics.

Pre-assignment details

Practices were paired and then randomized to assure similarity across intervention and usual care groups. A total of 35 Providers participated and 430 children/family were enrolled into the project.

Participants by arm

ArmCount
Usual Care
Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits.
220
FNPA Tool Intervention
FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool. FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits.
210
Total430

Withdrawals & dropouts

PeriodReasonFG000FG001
6 Month Follow up SurveyLost to Follow-up4860
6 Month MeasurementsUnable to attend11497
Baseline - 1 Month Follow up SurveyLost to Follow-up728

Baseline characteristics

CharacteristicUsual CareFNPA Tool InterventionTotal
Age, Categorical
<=18 years
220 Participants210 Participants430 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous10.4 years
STANDARD_DEVIATION 4.1
10.7 years
STANDARD_DEVIATION 4.1
10.6 years
STANDARD_DEVIATION 4.1
Body Mass Index19.8 kg/m²
STANDARD_DEVIATION 5.1
20.0 kg/m²
STANDARD_DEVIATION 5
19.9 kg/m²
STANDARD_DEVIATION 5.1
Region of Enrollment
United States
220 participants210 participants430 participants
Sex: Female, Male
Female
113 Participants117 Participants230 Participants
Sex: Female, Male
Male
107 Participants93 Participants200 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2200 / 210
serious
Total, serious adverse events
1 / 2200 / 210

Outcome results

Primary

Percentage of Patients With Documented Goal Setting

Health behavior change goal documented in charting of well-child visits.

Time frame: 2 weeks from encounter

Population: Manual chart review of the electronic medical record (EMR) was completed by the Research Team for all enrolled subjects in both study groups. Goal documentation was defined as any type of goal consisting of an active verb written either on the FNPA Tool which was completed during the well child visit or in Physician notes in the EMR for the visit.

ArmMeasureValue (NUMBER)
Usual CarePercentage of Patients With Documented Goal Setting4.09 percentage of participant charts
FNPA Tool InterventionPercentage of Patients With Documented Goal Setting71.90 percentage of participant charts
Secondary

BMI Z-score Change for Ages 11-17 Years

Time frame: Baseline and 6 months post encounter

ArmMeasureValue (MEAN)Dispersion
Usual CareBMI Z-score Change for Ages 11-17 Years0.14 BMI z-scoreStandard Deviation 0.32
FNPA Tool InterventionBMI Z-score Change for Ages 11-17 Years0.11 BMI z-scoreStandard Deviation 0.22
p-value: 0.588t-test, 2 sided
Secondary

BMI Z-score Change for Ages 4-10 Years

Time frame: Baseline and 6 months post encounter

ArmMeasureValue (MEAN)Dispersion
Usual CareBMI Z-score Change for Ages 4-10 Years0.13 BMI z-scoreStandard Deviation 0.69
FNPA Tool InterventionBMI Z-score Change for Ages 4-10 Years0.04 BMI z-scoreStandard Deviation 0.61
p-value: 0.4835t-test, 2 sided
Secondary

Obesiogenic Goal Setting Success

Degree to which an obesiogenic goal was set and carried out at 6 months after the encounter. Success defined as response of 2-4 on survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.

Time frame: 6 months after encounter

Population: This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 6 months after the medical encounter when goal was set.

ArmMeasureValue (NUMBER)
Usual CareObesiogenic Goal Setting Success100 percentage of participants
FNPA Tool InterventionObesiogenic Goal Setting Success99.17 percentage of participants
p-value: 1Chi-squared
Secondary

Obesiogenic Goal Setting Success

Degree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.

Time frame: 1 month after the encounter

Population: This analysis population only includes the participants who set an obesiogenic goal at the initial appointment and completed the 1 month post survey to rate their success level in achieving that goal.

ArmMeasureValue (NUMBER)
Usual CareObesiogenic Goal Setting Success87.27 percentage of participants
FNPA Tool InterventionObesiogenic Goal Setting Success98.55 percentage of participants
p-value: 0.0029Chi-squared
Secondary

Success of Obesiogenic Goals

Degree to which an obesiogenic goal was set and successfully carried out at 6 months post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.

Time frame: 6 months post encounter

Population: This analysis population only includes those participants who initially set an obesiogenic focused goal at their well child check and then responded to the survey 6 months after to rate their success level in achieving that goal.

ArmMeasureValue (NUMBER)
Usual CareSuccess of Obesiogenic Goals20.59 percentage of participants
FNPA Tool InterventionSuccess of Obesiogenic Goals60.67 percentage of participants
p-value: <0.000195% CI: [2, 4.5]Chi-squared
Secondary

Success of Obesiogenic Goals

Degree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.

Time frame: 1 month post encounter

Population: This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 1 month after the medical encounter to rate their level of success in achieving that goal.

ArmMeasureValue (NUMBER)
Usual CareSuccess of Obesiogenic Goals17.14 percentage of participants
FNPA Tool InterventionSuccess of Obesiogenic Goals56.18 percentage of participants
p-value: <0.000195% CI: [2.2, 4.9]Chi-squared
Secondary

Success of Other Health Goals

Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.

Time frame: 1 month post encounter

Population: This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 1 month post encounter.

ArmMeasureValue (NUMBER)
Usual CareSuccess of Other Health Goals88.46 percentage of participants
FNPA Tool InterventionSuccess of Other Health Goals90.91 percentage of participants
Secondary

Success of Other Health Goals

Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 6 months post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.

Time frame: 6 months post encounter

Population: This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 6 months post encounter.

ArmMeasureValue (NUMBER)
Usual CareSuccess of Other Health Goals100 percentage of participants
FNPA Tool InterventionSuccess of Other Health Goals100 percentage of participants
Other Pre-specified

BMI Z-score Change for All

Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.

Time frame: Baseline and 6 months after the encounter

Population: The number of participants analyzed is low because returning for measurement checks was optional at 6 months \& only 28% usual care and 27% intervention group attended. We also included chart abstraction measurements for those who had a return clinic visit with measurements within 6 months +/- 2 months from initial encounter.

ArmMeasureValue (MEAN)Dispersion
Usual CareBMI Z-score Change for All0.14 BMI z-scoreStandard Deviation 0.51
FNPA Tool InterventionBMI Z-score Change for All0.08 BMI z-scoreStandard Deviation 0.42
p-value: 0.3875t-test, 2 sided
Other Pre-specified

Obesity Follow-up Adherence

Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter

Time frame: 6 months after the encounter

Population: This analysis population only includes the subjects who were identified as obese at their initial appointment and had a 6 month follow up appointment scheduled at that time.

ArmMeasureValue (NUMBER)
Usual CareObesity Follow-up Adherence50 percentage of participants
FNPA Tool InterventionObesity Follow-up Adherence50 percentage of participants
p-value: >0.05Chi-squared
Other Pre-specified

Perception of Patient Centeredness of Encounter

Patient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot

Time frame: 1 month after the encounter

ArmMeasureValue (MEAN)Dispersion
Usual CarePerception of Patient Centeredness of Encounter3.42 units on a scaleStandard Deviation 0.45
FNPA Tool InterventionPerception of Patient Centeredness of Encounter3.67 units on a scaleStandard Deviation 0.39
p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026