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| Name | Class |
|---|---|
| Penn State University | OTHER |
| Iowa State University | OTHER |
| University of Nebraska | OTHER |
| Patient-Centered Outcomes Research Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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). | |
| Patient Reported Outcome | Active Comparator | 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 + Food Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Reported Outcome Well Child Visit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Raw BMI | Differences in raw BMI will be evaluated amongst study arms. | 1-year |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Bailey-Davis, DEd, RD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shawnee L Lutcher | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22799481 | Background | Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060. | |
| 31275595 | Background | Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun. |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. The number of dyads is represented in the Overall Number of Baseline Participants above. Baseline Characteristics for both parents and children are represented below.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only child age is represented. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | BMI z-score | 1-year |
|
1 year
There were no expected adverse and/or serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Limitations: Internal threats to validity may have influenced results including the Hawthorne effect and regression to the mean.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Bailey-Davis | Geisinger Health System | 570-214-9625 | ldbaileydavis@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2022 | Sep 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2021 | Sep 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| OTHER |
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|
| Patient Reported Outcome Well Child Visit + Food Care | Behavioral | 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-year |
| 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. | 1-year |
| 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. | 1-year |
| 1-year |
| Percentage of Children Overweight and Obese | Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions. | 1-year |
| 36572870 | Background | Bailey-Davis L, Moore AM, Poulsen MN, Dzewaltowski DA, Cummings S, DeCriscio LR, Hosterman JF, Huston D, Kirchner HL, Lutcher S, McCabe C, Welk GJ, Savage JS. Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial. BMC Public Health. 2022 Dec 26;22(1):2429. doi: 10.1186/s12889-022-14827-w. |
| 38496791 | Background | Potts BA, Wood GC, Bailey-Davis L. Agreement between parent-report and EMR height, weight, and BMI among rural children. Front Nutr. 2024 Mar 1;11:1279931. doi: 10.3389/fnut.2024.1279931. eCollection 2024. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Child Age (Months), mean (SD) |
|
| Sex/Gender, Customized | There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. | Count of Participants | Participants |
|
| Region of Enrollment | There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads. Data in this section are represented at the dyad not individual level as all participants were required to live in the United States. | Number | Parent/Child dyads |
|
| BMI z-score, mean (SD) | 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. | BMI z-score are only analyzed on children. | Mean | Standard Deviation | Child BMI z-score |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Only participants completing the Food Security section of the1-year survey were included in the overall number of participants analyzed. | Posted | Number | 95% Confidence Interval | Percentage Low or Very Low Food Security | 1-year |
|
|
|
| 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. | Only participants completing the M-PICS section of the1-year survey were included in the overall number of participants analyzed. | Posted | Mean | Standard Error | score on a scale | 1-year |
|
|
|
| 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. | Only participants completing the Food Resource Management section of the1-year survey were included in the overall number of participants analyzed. | Posted | Mean | Standard Error | Units on a scale | 1-year |
|
|
|
| Other Pre-specified | Raw BMI | Differences in raw BMI will be evaluated amongst study arms. | Posted | Mean | Standard Error | kg/m2 | 1-year |
|
|
|
| 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. | Posted | Mean | Standard Error | kg/m^2 | 1-year |
|
|
|
| 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. | Posted | Number | Percent of total population | 1-year |
|
|
|
| 0 |
| 711 |
| 0 |
| 711 |
| 0 |
| 711 |
| EG001 | 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. | 0 | 752 | 0 | 752 | 0 | 752 |
| EG002 | 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. | 0 | 577 | 0 | 577 | 0 | 577 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Unknown |
|
| White |
|
| Other |
|
| Unknown |
|
| Title | Measurements |
|---|---|
| Black |
|
| White |
|
| Other |
|
| Unknown |
|
| Non-Hispanic |
|
| Unknown |
|
| Title | Measurements |
|---|---|
| Hispanic |
|
| Non-Hispanic |
|
| Unknown |
|
|
| Title | Measurements |
|---|---|
|