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Completed

NCT Number: NCT04406441

Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children

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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Key information

Age range

20 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shawnee L Lutcher

Danville, Pennsylvania, 17822, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Difference in BMI Z-score, Based on WHO Growth Standards

    Time frame: 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 outcomes

  1. United States Household Food Security Survey Module: Six-Item Short Form

    Time frame: 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.

  2. Modified Version of Perceived Involvement in Care Scale

    Time frame: 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.

  3. Food Resource Management

    Time frame: 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 outcomes

  1. Raw BMI

    Time frame: 1-year

    Differences in raw BMI will be evaluated amongst study arms.

  2. BMI Units Above the 50th Percentile (BMI50)

    Time frame: 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.

  3. Percentage of Children Overweight and Obese

    Time frame: 1-year

    Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Iowa State University
  • Patient-Centered Outcomes Research Institute
  • Penn State University
  • University of Nebraska

Registry information

Acronym: ENCIRCLE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 28, 2020
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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