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

Pediatric Obesity Clinical Trial

— ENCIRCLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04406441
• Other study ID #: 2020-0207
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2040
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Food Supply
• Mentoring
• Obesity
• Pediatric Obesity
• Preventive Medicine

Intervention

Behavioral:
• 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 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.

Locations

Country	Name	City	State
United States	Shawnee L Lutcher	Danville	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Geisinger Clinic	Iowa State University, Patient-Centered Outcomes Research Institute, Penn State University, University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Raw BMI	Differences in raw BMI will be evaluated amongst study arms.	1-year
Other	Percent over BMI (BMI50)	Differences in BMI50 will be evaluated amongst study arms.	1-year
Other	Proportion of Children Overweight and Obese	Evaluate the proportion of children overweight and obese at 1-year follow-up per CDC guidance and definitions.	1-year
Other	BMIz extended	Difference in BMIz extended (CDC) will be evaluated between study arms.	1-year
Primary	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.	1-year
Secondary	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.	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. 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.	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. Change in food resource management by each subscale at 1-year are planned analyses.	1-year