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

Primary Purpose

Pediatric Obesity, Preventive Medicine, Mentoring

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Reported Outcome Well Child Visit
Patient Reported Outcome Well Child Visit + Food Care
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity

Eligibility Criteria

20 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shawnee L Lutcher

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard of Care

Patient Reported Outcome

Patient Reported Outcome + Food Care

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

difference in 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.) may be used to assess the primary outcome.

Secondary Outcome Measures

United States Household Food Security Survey Module: Six-Item Short Form
The Six-item short form is an abbreviated form of the 10- and 18-item longer scales from the Economic Research Service, United States Department of Agriculture. A score of 0-1 indicates high or marginal food security; a score of 2-4 indicates low food security; a score of 5-6 indicates very low food security. Change in household food security status at 1-year is a planned analysis.
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. Subscale results are provided for 4 domains (each scored on a 1-5 item Likert scale). 1- Health care provider information evaluates the degree to which the provider is perceived as controlling information with a higher score indicating more controlling behavior. 2- Patient information evaluates the extent to which the patient sought or shared information with a higher score indicating greater patient activation in information gathering. 3- Patient decision making evaluates patient participation in decision making during care with a higher score indicating greater participation. 4- Health care provider facilitation reflects patients encouragement to ask questions with a higher score indicating greater facilitation. There is not a summary score. Change in perceived involvement in care by each subscale at 1-year are planned analyses.
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. Change in food resource management by each subscale at 1-year are planned analyses.

Full Information

First Posted
May 21, 2020
Last Updated
August 16, 2023
Sponsor
Geisinger Clinic
Collaborators
Penn State University, Iowa State University, University of Nebraska, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04406441
Brief Title
Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
Acronym
ENCIRCLE
Official Title
Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
Collaborators
Penn State University, Iowa State University, University of Nebraska, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Preventive Medicine, Mentoring, Food Supply

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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).
Arm Title
Patient Reported Outcome
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient Reported Outcome + Food Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Reported Outcome Well Child Visit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Reported Outcome Well Child Visit + Food Care
Intervention Description
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 Outcome Measure Information:
Title
difference in difference in BMI z-score, based on WHO growth standards
Description
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.) may be used to assess the primary outcome.
Time Frame
1-year
Secondary Outcome Measure Information:
Title
United States Household Food Security Survey Module: Six-Item Short Form
Description
The Six-item short form is an abbreviated form of the 10- and 18-item longer scales from the Economic Research Service, United States Department of Agriculture. A score of 0-1 indicates high or marginal food security; a score of 2-4 indicates low food security; a score of 5-6 indicates very low food security. Change in household food security status at 1-year is a planned analysis.
Time Frame
1-year
Title
Modified Version of Perceived Involvement in Care Scale
Description
The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. Subscale results are provided for 4 domains (each scored on a 1-5 item Likert scale). 1- Health care provider information evaluates the degree to which the provider is perceived as controlling information with a higher score indicating more controlling behavior. 2- Patient information evaluates the extent to which the patient sought or shared information with a higher score indicating greater patient activation in information gathering. 3- Patient decision making evaluates patient participation in decision making during care with a higher score indicating greater participation. 4- Health care provider facilitation reflects patients encouragement to ask questions with a higher score indicating greater facilitation. There is not a summary score. Change in perceived involvement in care by each subscale at 1-year are planned analyses.
Time Frame
1-year
Title
Food Resource Management
Description
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. Change in food resource management by each subscale at 1-year are planned analyses.
Time Frame
1-year
Other Pre-specified Outcome Measures:
Title
Raw BMI
Description
Differences in raw BMI will be evaluated amongst study arms.
Time Frame
1-year
Title
Percent over BMI (BMI50)
Description
Differences in BMI50 will be evaluated amongst study arms.
Time Frame
1-year
Title
Proportion of Children Overweight and Obese
Description
Evaluate the proportion of children overweight and obese at 1-year follow-up per CDC guidance and definitions.
Time Frame
1-year
Title
BMIz extended
Description
Difference in BMIz extended (CDC) will be evaluated between study arms.
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Bailey-Davis, DEd, RD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shawnee L Lutcher
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22799481
Citation
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.
Results Reference
result
PubMed Identifier
31275595
Citation
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.
Results Reference
result

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

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