Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

NCT06078774 | Completed Results

• 1 other identifier: HM20026673
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Pediatric

Keywords

Obesity; House Calls; Pediatric Primary Care; Virtual; Telehealth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Body Mass Index Change

  6 months

• Adolescent Reported Authoritative Parenting Style

  Baseline, 3-, and 6-months

• Parent Reported Parenting Style

  Baseline, 3-, and 6-months

• Dietary Intake

  Baseline, 3-, and 6-months

• Physical Activity.

  Baseline, 3-, and 6-months

Study Arms (1)

Virtual Health Coach - Parent/Child Dyad

EXPERIMENTAL

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

Interventions

Virtual Health Coach BEHAVIORAL

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.

Virtual Health Coach - Parent/Child Dyad

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth Universiy

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sarah Farthing
• Organization: Virginia Commonwealth University

sarah.malone@vcuhealth.org

804-527-4756

Study Officials

• Melanie Bean, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: October 12, 2023
• Study Start: January 24, 2024
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (1)