Obesity
Conditions
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
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.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Documented Goal Setting | 2 weeks from encounter | Health behavior change goal documented in charting of well-child visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of Obesiogenic Goals | 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. |
| Success of Other Health Goals | 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. |
| BMI Z-score Change for Ages 4-10 Years | Baseline and 6 months post encounter | — |
| BMI Z-score Change for Ages 11-17 Years | Baseline and 6 months post encounter | — |
| Obesiogenic Goal Setting Success | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Obesity Follow-up Adherence | 6 months after the encounter | Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter |
| BMI Z-score Change for All | Baseline and 6 months after the encounter | Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter. |
| Perception of Patient Centeredness of Encounter | 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 |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6 Month Follow up Survey | Lost to Follow-up | 48 | 60 |
| 6 Month Measurements | Unable to attend | 114 | 97 |
| Baseline - 1 Month Follow up Survey | Lost to Follow-up | 7 | 28 |
Baseline characteristics
| Characteristic | Usual Care | FNPA Tool Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 220 Participants | 210 Participants | 430 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.4 years STANDARD_DEVIATION 4.1 | 10.7 years STANDARD_DEVIATION 4.1 | 10.6 years STANDARD_DEVIATION 4.1 |
| Body Mass Index | 19.8 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 participants | 210 participants | 430 participants |
| Sex: Female, Male Female | 113 Participants | 117 Participants | 230 Participants |
| Sex: Female, Male Male | 107 Participants | 93 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 220 | 0 / 210 |
| serious Total, serious adverse events | 1 / 220 | 0 / 210 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Patients With Documented Goal Setting | 4.09 percentage of participant charts |
| FNPA Tool Intervention | Percentage of Patients With Documented Goal Setting | 71.90 percentage of participant charts |
BMI Z-score Change for Ages 11-17 Years
Time frame: Baseline and 6 months post encounter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | BMI Z-score Change for Ages 11-17 Years | 0.14 BMI z-score | Standard Deviation 0.32 |
| FNPA Tool Intervention | BMI Z-score Change for Ages 11-17 Years | 0.11 BMI z-score | Standard Deviation 0.22 |
BMI Z-score Change for Ages 4-10 Years
Time frame: Baseline and 6 months post encounter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | BMI Z-score Change for Ages 4-10 Years | 0.13 BMI z-score | Standard Deviation 0.69 |
| FNPA Tool Intervention | BMI Z-score Change for Ages 4-10 Years | 0.04 BMI z-score | Standard Deviation 0.61 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Obesiogenic Goal Setting Success | 100 percentage of participants |
| FNPA Tool Intervention | Obesiogenic Goal Setting Success | 99.17 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Obesiogenic Goal Setting Success | 87.27 percentage of participants |
| FNPA Tool Intervention | Obesiogenic Goal Setting Success | 98.55 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Success of Obesiogenic Goals | 20.59 percentage of participants |
| FNPA Tool Intervention | Success of Obesiogenic Goals | 60.67 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Success of Obesiogenic Goals | 17.14 percentage of participants |
| FNPA Tool Intervention | Success of Obesiogenic Goals | 56.18 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Success of Other Health Goals | 88.46 percentage of participants |
| FNPA Tool Intervention | Success of Other Health Goals | 90.91 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Success of Other Health Goals | 100 percentage of participants |
| FNPA Tool Intervention | Success of Other Health Goals | 100 percentage of participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | BMI Z-score Change for All | 0.14 BMI z-score | Standard Deviation 0.51 |
| FNPA Tool Intervention | BMI Z-score Change for All | 0.08 BMI z-score | Standard Deviation 0.42 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Obesity Follow-up Adherence | 50 percentage of participants |
| FNPA Tool Intervention | Obesity Follow-up Adherence | 50 percentage of participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Perception of Patient Centeredness of Encounter | 3.42 units on a scale | Standard Deviation 0.45 |
| FNPA Tool Intervention | Perception of Patient Centeredness of Encounter | 3.67 units on a scale | Standard Deviation 0.39 |