Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

This study examines a redesign of pediatric primary care overweight/obesity treatment, augmenting typical in-person visits with: (1) direct-to-patient video telehealth to tailor counseling advice to families, (2) that leverages certified health coaches as a part of the care team, and (3) creates skills building in real-time within the home environment.

Study Overview

• Status: Completed
• Conditions: Obesity, Pediatric
• Intervention / Treatment: Behavioral: Virtual Health Coach

Detailed Description

Investigators will recruit children with an elevated body mass index (BMI) (85th to <99th percentile) and a parent. Dyads will participate in a 24-week intervention with a total of 26 contact hours. Dyads will participate in weekly education sessions for the first 12 weeks and bi-weekly sessions for the remaining 12 weeks. Additionally, dyads will participate in weekly exercise sessions.

Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth Universiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Children:

• Ages 9-13 years
• BMI 85th to <99th percentile
• Must be a patient within Health System Pediatric Primary Care
• Must be English or Spanish speaking

Parent:

-Must be English or Spanish speaking

Exclusion Criteria:

Children:

• Cannot have an emotional, social, or physical disability that would prevent them from participating in the protocol
• Non-English or Non-Spanish speaking
• Cannot have a medical condition resulting in unintentional weight gain (i.e. Prader Willi)
• Females cannot be pregnant
• In addition, children will potentially be excluded from participation if they have a positive screen during an interview led pre-screening eating disorder questionnaire

Parent:

-Non-English or Non-Spanish speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Health Coach - Parent/Child Dyad; Focuses on providing personalized care conveyed in an integrated and visually demonstrated way for parent-child pairs. Healthy lifestyle changes and behaviors covered in sessions are designed to initiate and maintain behavior change in nutrition and physical activity with BMI improvement.

Behavioral: Virtual Health Coach; Dyads first session will be 60-minutes, totaling 1 hour. Dyads will participate in weekly 30-minute sessions for weeks 2-12, totaling 5.5 hours. Dyads will participate bi-weekly 30-minute sessions for 12 weeks, totaling 3 hours. Dyads will participate in weekly 30-minute exercise sessions for 24-weeks, totaling 12 hours. Children will have 3, 30-minute visits with their primary care physician (PCP) every 3 months, totaling 1.5 hours. Parents will have three, 60-minute individual sessions, totaling 3 hours. Total study duration is 24 weeks, with a total of 26 contact hours. Sessions follow a behavior therapy approach, including guided goal-setting, self-monitoring, identifying barriers and solutions, contingency management, stimulus control, dealing with setbacks, maintenance and relapse prevention. Weight is assessed weekly by coaches, with MI-consistent, autonomy-supportive feedback provided. Parent sessions will focus on ways to support their child's weight management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of Participants.	Percentage of participants recruited compared to goal sample size.	6 months
Retention of Participants	Ability to retain 70% of participants at primary end point.	6 months
Number of Participants Who Reported Being Satisfied With the Intervention	Measured in an exit interview. Participants were asked if they benefited from the program.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index Change	Body Mass Index change (kg/m2) from baseline to 6-months for child and parent. National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI).	6 months
Adolescent Reported Authoritative Parenting Style	The Authoritative Parenting Index (API) was used to assess adolescent-report of authoritative parenting style. Scores range from 16-64 with higher scores indicating the adolescent perceives their parent to have a higher level of authoritative parenting behavior. Results reflect the adolescent's perception on their parent (mom or dad) who participated in the study.	Baseline, 3-, and 6-months
Parent Reported Parenting Style	The Parenting Styles and Dimension Questionnaire (PSDQ) was administered to parents to assess parent self-report of authoritative parenting style. Results reflect the participating parent's perception of their parenting style. Scores range from 1-5 with higher scoring indicating a greater frequency of authoritative parenting behaviors.	Baseline, 3-, and 6-months
Dietary Intake	Child participants completed a 24-hour food recall using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. Total energy intake is reported from the 24-hour recall.	Baseline, 3-, and 6-months
Physical Activity.	Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire. The measure is scored by averaging responses with a range of 0-7. Higher scores (5-7) indicate meeting activity guidelines.	Baseline, 3-, and 6-months
Parent Reported Sleep Duration for Child	Parents completed a subset of questions from the National Health and Nutrition Examination Survey (NHANES) regarding their child's sleep behaviors. Data is reported sleep duration (hours) for child on weekdays/school days.	Baseline, 3-month, and 6-month
Home Food Environment.	The Home Food Inventory (HFI) was used to assess the availability of types of food in the home and calculate an overall obesogenic score. Scores range from 0-60, with high scores indicating a more obesogenic food environment.	Baseline, 3-, and 6-months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Melanie Bean, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): August 16, 2024
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Telehealth; Virtual; House Calls; Pediatric Primary Care
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Pediatric Obesity
• Other Study ID Numbers: HM20026673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No