Adults 20 Months to 59 Months, any sex, with Pediatric Obesity or Preventive Medicine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in BMI Z-score, Based on WHO Growth StandardsPrimary· 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 over
Group
Value
95% CI
Standard of Care
1.005
± 0.068
Patient Reported Outcome
0.881
± 0.066
Patient Reported Outcome + Food Care
0.979
± 0.073
United States Household Food Security Survey Module: Six-Item Short FormSecondary· 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 foo
Group
Value
95% CI
Standard of Care
16.9
13.8 – 20.5
Patient Reported Outcome
18.4
15.3 – 21.9
Patient Reported Outcome + Food Care
21.4
17.6 – 25.8
Modified Version of Perceived Involvement in Care ScaleSecondary· 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.
Group
Value
95% CI
Standard of Care
71.81
± 0.72
Patient Reported Outcome
71.99
± 0.71
Patient Reported Outcome + Food Care
72.92
± 0.77
Food Resource ManagementSecondary· 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
Food Resource Management Practices
Group
Value
95% CI
Standard of Care
3.76
± 0.04
Patient Reported Outcome
3.74
± 0.04
Patient Reported Outcome + Food Care
3.78
± 0.04
Food Resource Management Confidence
Group
Value
95% CI
Standard of Care
3.96
± 0.05
Patient Reported Outcome
3.93
± 0.05
Patient Reported Outcome + Food Care
4.03
± 0.05
Raw BMISecondary· 1-year
Differences in raw BMI will be evaluated amongst study arms.
Group
Value
95% CI
Standard of Care
16.952
± 0.114
Patient Reported Outcome
16.735
± 0.112
Patient Reported Outcome + Food Care
16.967
± 0.125
BMI Units Above the 50th Percentile (BMI50)Secondary· 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.
Group
Value
95% CI
Standard of Care
1.596
± 0.114
Patient Reported Outcome
1.373
± 0.113
Patient Reported Outcome + Food Care
1.609
± 0.126
Percentage of Children Overweight and ObeseSecondary· 1-year
Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions.
% Overweight
Group
Value
95% CI
Standard of Care
40.52
Patient Reported Outcome
41.25
Patient Reported Outcome + Food Care
41.54
% Obese
Group
Value
95% CI
Standard of Care
22.89
Patient Reported Outcome
23.56
Patient Reported Outcome + Food Care
22.85
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Geisinger Clinic
Last refreshed: 5 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04406441.