UnityPointHealth Methodist in Peoria
Peoria, Illinois, 61636, United States
NCT Number: NCT02067728
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.
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Notify Me4 year–17 year
All sexes
Interventional
Not applicable
Peoria, Illinois, 61636, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Patients with chronic medical conditions or developmental delays that preclude age appropriate nutrition and physical activity habits will be excluded. -
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.
Time frame: 2 weeks from encounter
Health behavior change goal documented in charting of well-child visits.
Time frame: 1 month after the encounter
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: 6 months after encounter
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: 1 month post encounter
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: 6 months post encounter
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: 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.
Time frame: 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.
Time frame: Baseline and 6 months post encounter
Time frame: Baseline and 6 months post encounter
Time frame: Baseline and 6 months after the encounter
Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.
Time frame: 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
Time frame: 6 months after the encounter
Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter
University of Illinois at Chicago
Other
Family Nutrition, Physical Activity (FNPA) Tool: a Motivational Interviewing-based Practice Intervention to Address Pediatric Health Behaviors
Acronym: FNPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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