Food Supply, Mentoring, Pediatric Obesity, Preventive Medicine
Conditions
Brief summary
The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.
Interventions
BEHAVIORALPatient Reported Outcome Well Child Visit
Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.
BEHAVIORALPatient Reported Outcome Well Child Visit + Food Care
Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.
Sponsors
Penn State University
Iowa State University
University of Nebraska
Patient-Centered Outcomes Research Institute
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Months to 59 Months
Healthy volunteers
Yes
Inclusion criteria
* Age (20-months to 59-months, 29-days old) * BMI-for-age and -sex \>50th percentile based on WHO growth standards * Parent commitment to participate in 18-month study * Plans to attend scheduled WCV and recommended follow-up WCV in 12 months * No plans to move or change health systems in 2 years * Parent age \> 18 years * Parent is English-speaking * Household is considered lower-income (i.e., eligible for or receiving Special Supplemental Nutrition Program for Women, Infants and Children \[WIC\], Supplemental Nutrition Assistance Program \[SNAP\], Temporary Assistance for Needy Families \[TANF\], Medicaid, or Children's Health Insurance Program \[CHIP\]) or screens positive for food insecurity.
Exclusion criteria
* Another child in family is participating * Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism) * Parents with self-reported major depression will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in BMI Z-score, Based on WHO Growth Standards | 1-year | BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over \>=1 indicates possible risk for overweight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| United States Household Food Security Survey Module: Six-Item Short Form | 1-year | This questionnaire uses 6 items to provide a scale of food security of high food security to very low food security. Scoring: Responses of often or sometimes on questions Q1 and Q2, and yes on Q3, Q5, and Q6 are coded as affirmative (yes). Responses of almost every month and some months but not every month on Q4 are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale); Raw score 2-4-Low food security. Raw score 5-6-Very low food security. Percentage of participants with low or very low food security scores were reported. |
| Modified Version of Perceived Involvement in Care Scale | 1-year | The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. PICs includes 4 domains including 1-Health care provider information 2- Patient information 3- Patient decision making 4- Health care provider facilitation. The total score combines these 4 domains with a range from 20 poor-100 high reported at 12-month follow-up. |
| Food Resource Management | 1-year | Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. The scoring for each subscale uses the average of items within that subscale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI Units Above the 50th Percentile (BMI50) | 1-year | Differences in BMI50 will be evaluated amongst study arms. We reported using mean number of BMI units from the population mean which is defined as the distance from the BMI for age and sex at the 50th %tile. |
| Percentage of Children Overweight and Obese | 1-year | Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions. |
| Raw BMI | 1-year | Differences in raw BMI will be evaluated amongst study arms. |
Countries
United States
Participant flow
Recruitment details
Primary Care Providers were the unit of randomization in this study. Parent/child dyads were enrolled and were assigned to one of the three study arms based on which provider they saw for their regular well-child visits. There were 105 providers trained and randomized, 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. Below enrollment data reflects the randomization of the parent/child dyads.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling). | 1,422 |
| Patient Reported Outcome Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care.
Patient Reported Outcome Well Child Visit: Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided. | 1,504 |
| Patient Reported Outcome + Food Care Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program.
Patient Reported Outcome Well Child Visit + Food Care: Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period. | 1,154 |
| Total | 4,080 |
Baseline characteristics
| Characteristic | Total | Patient Reported Outcome | Patient Reported Outcome + Food Care | Standard of Care |
|---|---|---|---|---|
| Age, Continuous | 35.5 Child Age (Months), mean (SD) STANDARD_DEVIATION 11.1 | 35.2 Child Age (Months), mean (SD) STANDARD_DEVIATION 11.2 | 35.4 Child Age (Months), mean (SD) STANDARD_DEVIATION 10.9 | 35.8 Child Age (Months), mean (SD) STANDARD_DEVIATION 11.3 |
| BMI z-score, mean (SD) | 1.0 Child BMI z-score STANDARD_DEVIATION 1.23 | 0.92 Child BMI z-score STANDARD_DEVIATION 1.08 | 1.03 Child BMI z-score STANDARD_DEVIATION 1.31 | 1.05 Child BMI z-score STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Ethnicity of Child Hispanic | 238 Participants | 78 Participants | 63 Participants | 97 Participants |
| Race/Ethnicity, Customized Ethnicity of Child Non-Hispanic | 1802 Participants | 674 Participants | 514 Participants | 614 Participants |
| Race/Ethnicity, Customized Ethnicity of Child Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity of Parent Hispanic | 210 Participants | 74 Participants | 56 Participants | 80 Participants |
| Race/Ethnicity, Customized Ethnicity of Parent Non-Hispanic | 1782 Participants | 657 Participants | 508 Participants | 617 Participants |
| Race/Ethnicity, Customized Ethnicity of Parent Unknown | 48 Participants | 21 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized Race of Child Black | 155 Participants | 39 Participants | 46 Participants | 70 Participants |
| Race/Ethnicity, Customized Race of Child Other | 70 Participants | 23 Participants | 25 Participants | 22 Participants |
| Race/Ethnicity, Customized Race of Child Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race of Child White | 1815 Participants | 690 Participants | 506 Participants | 619 Participants |
| Race/Ethnicity, Customized Race of Parent Black | 112 Participants | 20 Participants | 31 Participants | 61 Participants |
| Race/Ethnicity, Customized Race of Parent Other | 158 Participants | 51 Participants | 42 Participants | 65 Participants |
| Race/Ethnicity, Customized Race of Parent Unknown | 62 Participants | 30 Participants | 15 Participants | 17 Participants |
| Race/Ethnicity, Customized Race of Parent White | 1708 Participants | 651 Participants | 489 Participants | 568 Participants |
| Region of Enrollment United States | 2040 Parent/Child dyads | 752 Parent/Child dyads | 577 Parent/Child dyads | 711 Parent/Child dyads |
| Sex/Gender, Customized Sex of Child Female | 990 Participants | 388 Participants | 269 Participants | 333 Participants |
| Sex/Gender, Customized Sex of Child Male | 1050 Participants | 364 Participants | 308 Participants | 378 Participants |
| Sex/Gender, Customized Sex of Child Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex of Parent Female | 1898 Participants | 696 Participants | 539 Participants | 663 Participants |
| Sex/Gender, Customized Sex of Parent Male | 96 Participants | 33 Participants | 29 Participants | 34 Participants |
| Sex/Gender, Customized Sex of Parent Unknown | 46 Participants | 23 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 711 | 0 / 752 | 0 / 577 |
| other Total, other adverse events | 0 / 711 | 0 / 752 | 0 / 577 |
| serious Total, serious adverse events | 0 / 711 | 0 / 752 | 0 / 577 |
Outcome results
Primary
Difference in BMI Z-score, Based on WHO Growth Standards
BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over \>=1 indicates possible risk for overweight.
Time frame: 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Difference in BMI Z-score, Based on WHO Growth Standards | 1.005 BMI z-score | Standard Error 0.068 |
| Patient Reported Outcome | Difference in BMI Z-score, Based on WHO Growth Standards | 0.881 BMI z-score | Standard Error 0.066 |
| Patient Reported Outcome + Food Care | Difference in BMI Z-score, Based on WHO Growth Standards | 0.979 BMI z-score | Standard Error 0.073 |
Secondary
Food Resource Management
Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. The scoring for each subscale uses the average of items within that subscale.
Time frame: 1-year
Population: Only participants completing the Food Resource Management section of the1-year survey were included in the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Food Resource Management | Food Resource Management Practices | 3.76 Units on a scale | Standard Error 0.04 |
| Standard of Care | Food Resource Management | Food Resource Management Confidence | 3.96 Units on a scale | Standard Error 0.05 |
| Patient Reported Outcome | Food Resource Management | Food Resource Management Practices | 3.74 Units on a scale | Standard Error 0.04 |
| Patient Reported Outcome | Food Resource Management | Food Resource Management Confidence | 3.93 Units on a scale | Standard Error 0.05 |
| Patient Reported Outcome + Food Care | Food Resource Management | Food Resource Management Practices | 3.78 Units on a scale | Standard Error 0.04 |
| Patient Reported Outcome + Food Care | Food Resource Management | Food Resource Management Confidence | 4.03 Units on a scale | Standard Error 0.05 |
Secondary
Modified Version of Perceived Involvement in Care Scale
The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. PICs includes 4 domains including 1-Health care provider information 2- Patient information 3- Patient decision making 4- Health care provider facilitation. The total score combines these 4 domains with a range from 20 poor-100 high reported at 12-month follow-up.
Time frame: 1-year
Population: Only participants completing the M-PICS section of the1-year survey were included in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Modified Version of Perceived Involvement in Care Scale | 71.81 score on a scale | Standard Error 0.72 |
| Patient Reported Outcome | Modified Version of Perceived Involvement in Care Scale | 71.99 score on a scale | Standard Error 0.71 |
| Patient Reported Outcome + Food Care | Modified Version of Perceived Involvement in Care Scale | 72.92 score on a scale | Standard Error 0.77 |
Secondary
United States Household Food Security Survey Module: Six-Item Short Form
This questionnaire uses 6 items to provide a scale of food security of high food security to very low food security. Scoring: Responses of often or sometimes on questions Q1 and Q2, and yes on Q3, Q5, and Q6 are coded as affirmative (yes). Responses of almost every month and some months but not every month on Q4 are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale); Raw score 2-4-Low food security. Raw score 5-6-Very low food security. Percentage of participants with low or very low food security scores were reported.
Time frame: 1-year
Population: Only participants completing the Food Security section of the1-year survey were included in the overall number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | United States Household Food Security Survey Module: Six-Item Short Form | 16.9 Percentage Low or Very Low Food Security |
| Patient Reported Outcome | United States Household Food Security Survey Module: Six-Item Short Form | 18.4 Percentage Low or Very Low Food Security |
| Patient Reported Outcome + Food Care | United States Household Food Security Survey Module: Six-Item Short Form | 21.4 Percentage Low or Very Low Food Security |
Other Pre-specified
BMI Units Above the 50th Percentile (BMI50)
Differences in BMI50 will be evaluated amongst study arms. We reported using mean number of BMI units from the population mean which is defined as the distance from the BMI for age and sex at the 50th %tile.
Time frame: 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | BMI Units Above the 50th Percentile (BMI50) | 1.596 kg/m^2 | Standard Error 0.114 |
| Patient Reported Outcome | BMI Units Above the 50th Percentile (BMI50) | 1.373 kg/m^2 | Standard Error 0.113 |
| Patient Reported Outcome + Food Care | BMI Units Above the 50th Percentile (BMI50) | 1.609 kg/m^2 | Standard Error 0.126 |
Other Pre-specified
Percentage of Children Overweight and Obese
Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions.
Time frame: 1-year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Children Overweight and Obese | % Overweight | 40.52 Percent of total population |
| Standard of Care | Percentage of Children Overweight and Obese | % Obese | 22.89 Percent of total population |
| Patient Reported Outcome | Percentage of Children Overweight and Obese | % Overweight | 41.25 Percent of total population |
| Patient Reported Outcome | Percentage of Children Overweight and Obese | % Obese | 23.56 Percent of total population |
| Patient Reported Outcome + Food Care | Percentage of Children Overweight and Obese | % Overweight | 41.54 Percent of total population |
| Patient Reported Outcome + Food Care | Percentage of Children Overweight and Obese | % Obese | 22.85 Percent of total population |
Other Pre-specified
Raw BMI
Differences in raw BMI will be evaluated amongst study arms.
Time frame: 1-year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Raw BMI | 16.952 kg/m2 | Standard Error 0.114 |
| Patient Reported Outcome | Raw BMI | 16.735 kg/m2 | Standard Error 0.112 |
| Patient Reported Outcome + Food Care | Raw BMI | 16.967 kg/m2 | Standard Error 0.125 |