Trial Outcomes & Findings for Family Nutrition Physical Activity Tool Use During Well Child Visits (NCT NCT02067728)

NCT ID: NCT02067728

Last Updated: 2016-03-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 430 participants
• Primary outcome timeframe: 2 weeks from encounter
• Results posted on: 2016-03-23

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Baseline - 1 Month Follow up Survey STARTED	220	210
Baseline - 1 Month Follow up Survey COMPLETED	213	182
Baseline - 1 Month Follow up Survey NOT COMPLETED	7	28
6 Month Follow up Survey STARTED	220	210
6 Month Follow up Survey COMPLETED	172	150
6 Month Follow up Survey NOT COMPLETED	48	60
6 Month Measurements STARTED	220	210
6 Month Measurements COMPLETED	106	113
6 Month Measurements NOT COMPLETED	114	97

Reasons for withdrawal

Measure	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.	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.
Baseline - 1 Month Follow up Survey Lost to Follow-up	7	28
6 Month Follow up Survey Lost to Follow-up	48	60
6 Month Measurements Unable to attend	114	97

Baseline Characteristics

Family Nutrition Physical Activity Tool Use During Well Child Visits

Baseline characteristics by cohort

Measure	Usual Care n=220 Participants 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.	FNPA Tool Intervention n=210 Participants 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.	Total n=430 Participants Total of all reporting groups
Age, Categorical <=18 years	220 Participants n=5 Participants	210 Participants n=7 Participants	430 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.4 years STANDARD_DEVIATION 4.1 • n=5 Participants	10.7 years STANDARD_DEVIATION 4.1 • n=7 Participants	10.6 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	117 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	93 Participants n=7 Participants	200 Participants n=5 Participants
Region of Enrollment United States	220 participants n=5 Participants	210 participants n=7 Participants	430 participants n=5 Participants
Body Mass Index	19.8 kg/m² STANDARD_DEVIATION 5.1 • n=5 Participants	20.0 kg/m² STANDARD_DEVIATION 5.0 • n=7 Participants	19.9 kg/m² STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Usual Care n=220 Participants 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.	FNPA Tool Intervention n=210 Participants 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.
Percentage of Patients With Documented Goal Setting	4.09 percentage of participant charts	71.90 percentage of participant charts

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=55 Participants 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.	FNPA Tool Intervention n=138 Participants 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.
Obesiogenic Goal Setting Success	87.27 percentage of participants	98.55 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=50 Participants 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.	FNPA Tool Intervention n=121 Participants 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.
Obesiogenic Goal Setting Success	100 percentage of participants	99.17 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=210 Participants 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.	FNPA Tool Intervention n=178 Participants 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.
Success of Obesiogenic Goals	17.14 percentage of participants	56.18 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=170 Participants 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.	FNPA Tool Intervention n=150 Participants 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.
Success of Obesiogenic Goals	20.59 percentage of participants	60.67 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=26 Participants 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.	FNPA Tool Intervention n=33 Participants 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.
Success of Other Health Goals	88.46 percentage of participants	90.91 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Usual Care n=18 Participants 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.	FNPA Tool Intervention n=28 Participants 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.
Success of Other Health Goals	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 6 months post encounter

Outcome measures

Measure	Usual Care n=44 Participants 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.	FNPA Tool Intervention n=45 Participants 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.
BMI Z-score Change for Ages 4-10 Years	0.13 BMI z-score Standard Deviation 0.69	0.04 BMI z-score Standard Deviation 0.61

SECONDARY outcome

Timeframe: Baseline and 6 months post encounter

Outcome measures

Measure	Usual Care n=62 Participants 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.	FNPA Tool Intervention n=68 Participants 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.
BMI Z-score Change for Ages 11-17 Years	0.14 BMI z-score Standard Deviation 0.32	0.11 BMI z-score Standard Deviation 0.22

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Measure	Usual Care n=106 Participants 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.	FNPA Tool Intervention n=113 Participants 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.
BMI Z-score Change for All	0.14 BMI z-score Standard Deviation 0.51	0.08 BMI z-score Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month after the 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

Outcome measures

Measure	Usual Care n=193 Participants 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.	FNPA Tool Intervention n=179 Participants 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.
Perception of Patient Centeredness of Encounter	3.42 units on a scale Standard Deviation 0.45	3.67 units on a scale Standard Deviation 0.39

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Measure	Usual Care n=4 Participants 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.	FNPA Tool Intervention n=2 Participants 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.
Obesity Follow-up Adherence	50 percentage of participants	50 percentage of participants

Adverse Events

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

FNPA Tool Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=220 participants at risk 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.	FNPA Tool Intervention n=210 participants at risk 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.
Social circumstances Death of patient	0.45% 1/220 • Adverse event data was collected from the date of initial encounter (enrollment date) to the date of the completion of the 6 month follow up survey data collection.	0.00% 0/210 • Adverse event data was collected from the date of initial encounter (enrollment date) to the date of the completion of the 6 month follow up survey data collection.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy L. Christison

University of Illinois College of Medicine at Peoria

Phone: 309-655-3613

Email: alc@uicomp.uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place