Trial Outcomes & Findings for Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children (NCT NCT04406441)
NCT ID: NCT04406441
Last Updated: 2025-03-05
Results Overview
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.
COMPLETED
NA
2040 participants
1-year
2025-03-05
Participant Flow
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.
Unit of analysis: Providers
Participant milestones
| Measure |
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).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1422 34
|
1504 35
|
1154 36
|
|
Overall Study
Parents
|
711 34
|
752 35
|
577 36
|
|
Overall Study
Children
|
711 34
|
752 35
|
577 36
|
|
Overall Study
COMPLETED
|
1422 34
|
1504 35
|
1154 36
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only child age is represented.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=1422 Participants
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
n=1504 Participants
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.
|
Patient Reported Outcome + Food Care
n=1154 Participants
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.
|
Total
n=4080 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.8 Child Age (Months), mean (SD)
STANDARD_DEVIATION 11.3 • n=711 Participants • Only child age is represented.
|
35.2 Child Age (Months), mean (SD)
STANDARD_DEVIATION 11.2 • n=752 Participants • Only child age is represented.
|
35.4 Child Age (Months), mean (SD)
STANDARD_DEVIATION 10.9 • n=577 Participants • Only child age is represented.
|
35.5 Child Age (Months), mean (SD)
STANDARD_DEVIATION 11.1 • n=2040 Participants • Only child age is represented.
|
|
Sex/Gender, Customized
Sex of Child · Female
|
333 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
388 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
269 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
990 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Sex/Gender, Customized
Sex of Child · Male
|
378 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
364 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
308 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1050 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Sex/Gender, Customized
Sex of Child · Unknown
|
0 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Sex/Gender, Customized
Sex of Parent · Female
|
663 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
696 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
539 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1898 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Sex/Gender, Customized
Sex of Parent · Male
|
34 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
33 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
29 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
96 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Sex/Gender, Customized
Sex of Parent · Unknown
|
14 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
23 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
9 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
46 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Child · Black
|
70 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
39 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
46 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
155 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Child · White
|
619 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
690 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
506 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1815 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Child · Other
|
22 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
23 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
25 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
70 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Child · Unknown
|
0 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Parent · Black
|
61 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
20 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
31 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
112 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Parent · White
|
568 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
651 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
489 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1708 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Parent · Other
|
65 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
51 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
42 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
158 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Race of Parent · Unknown
|
17 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
30 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
15 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
62 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Child · Hispanic
|
97 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
78 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
63 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
238 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Child · Non-Hispanic
|
614 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
674 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
514 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1802 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Child · Unknown
|
0 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
0 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Parent · Hispanic
|
80 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
74 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
56 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
210 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Parent · Non-Hispanic
|
617 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
657 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
508 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
1782 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Race/Ethnicity, Customized
Ethnicity of Parent · Unknown
|
14 Participants
n=711 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
21 Participants
n=752 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
13 Participants
n=577 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
48 Participants
n=2040 Participants • There were 2040 unique parents and 2040 unique children that combined to form 2040 parent/child dyads.
|
|
Region of Enrollment
United States
|
711 Parent/Child dyads
n=711 Participants • 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.
|
752 Parent/Child dyads
n=752 Participants • 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.
|
577 Parent/Child dyads
n=577 Participants • 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.
|
2040 Parent/Child dyads
n=2040 Participants • 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.
|
|
BMI z-score, mean (SD)
|
1.05 Child BMI z-score
STANDARD_DEVIATION 1.30 • n=711 Participants • BMI z-score are only analyzed on children.
|
0.92 Child BMI z-score
STANDARD_DEVIATION 1.08 • n=752 Participants • BMI z-score are only analyzed on children.
|
1.03 Child BMI z-score
STANDARD_DEVIATION 1.31 • n=577 Participants • BMI z-score are only analyzed on children.
|
1.0 Child BMI z-score
STANDARD_DEVIATION 1.23 • n=2040 Participants • BMI z-score are only analyzed on children.
|
PRIMARY outcome
Timeframe: 1-yearBMI 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.
Outcome measures
| Measure |
Standard of Care
n=711 Participants
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
n=752 Participants
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.
|
Patient Reported Outcome + Food Care
n=577 Participants
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.
|
|---|---|---|---|
|
Difference in BMI Z-score, Based on WHO Growth Standards
|
1.005 BMI z-score
Standard Error 0.068
|
0.881 BMI z-score
Standard Error 0.066
|
0.979 BMI z-score
Standard Error 0.073
|
SECONDARY outcome
Timeframe: 1-yearPopulation: Only participants completing the Food Security section of the1-year survey were included in the overall number of participants analyzed.
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.
Outcome measures
| Measure |
Standard of Care
n=566 Participants
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
n=594 Participants
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.
|
Patient Reported Outcome + Food Care
n=462 Participants
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.
|
|---|---|---|---|
|
United States Household Food Security Survey Module: Six-Item Short Form
|
16.9 Percentage Low or Very Low Food Security
Interval 13.8 to 20.5
|
18.4 Percentage Low or Very Low Food Security
Interval 15.3 to 21.9
|
21.4 Percentage Low or Very Low Food Security
Interval 17.6 to 25.8
|
SECONDARY outcome
Timeframe: 1-yearPopulation: Only participants completing the M-PICS section of the1-year survey were included in the overall number of participants analyzed.
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.
Outcome measures
| Measure |
Standard of Care
n=581 Participants
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
n=605 Participants
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.
|
Patient Reported Outcome + Food Care
n=475 Participants
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.
|
|---|---|---|---|
|
Modified Version of Perceived Involvement in Care Scale
|
71.81 score on a scale
Standard Error 0.72
|
71.99 score on a scale
Standard Error 0.71
|
72.92 score on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: 1-yearPopulation: Only participants completing the Food Resource Management section of the1-year survey were included in the overall number of participants analyzed.
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.
Outcome measures
| Measure |
Standard of Care
n=566 Participants
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
n=594 Participants
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.
|
Patient Reported Outcome + Food Care
n=462 Participants
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.
|
|---|---|---|---|
|
Food Resource Management
Food Resource Management Practices
|
3.76 Units on a scale
Standard Error 0.04
|
3.74 Units on a scale
Standard Error 0.04
|
3.78 Units on a scale
Standard Error 0.04
|
|
Food Resource Management
Food Resource Management Confidence
|
3.96 Units on a scale
Standard Error 0.05
|
3.93 Units on a scale
Standard Error 0.05
|
4.03 Units on a scale
Standard Error 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-yearDifferences in raw BMI will be evaluated amongst study arms.
Outcome measures
| Measure |
Standard of Care
n=711 Participants
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
n=752 Participants
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.
|
Patient Reported Outcome + Food Care
n=577 Participants
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.
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|---|---|---|---|
|
Raw BMI
|
16.952 kg/m2
Standard Error 0.114
|
16.735 kg/m2
Standard Error 0.112
|
16.967 kg/m2
Standard Error 0.125
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-yearDifferences 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.
Outcome measures
| Measure |
Standard of Care
n=711 Participants
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
n=752 Participants
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.
|
Patient Reported Outcome + Food Care
n=577 Participants
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.
|
|---|---|---|---|
|
BMI Units Above the 50th Percentile (BMI50)
|
1.596 kg/m^2
Standard Error 0.114
|
1.373 kg/m^2
Standard Error 0.113
|
1.609 kg/m^2
Standard Error 0.126
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-yearEvaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions.
Outcome measures
| Measure |
Standard of Care
n=711 Participants
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
n=752 Participants
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.
|
Patient Reported Outcome + Food Care
n=577 Participants
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.
|
|---|---|---|---|
|
Percentage of Children Overweight and Obese
% Overweight
|
40.52 Percent of total population
|
41.25 Percent of total population
|
41.54 Percent of total population
|
|
Percentage of Children Overweight and Obese
% Obese
|
22.89 Percent of total population
|
23.56 Percent of total population
|
22.85 Percent of total population
|
Adverse Events
Standard of Care
Patient Reported Outcome
Patient Reported Outcome + Food Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place