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Clinical Trials/NCT06078774
NCT06078774CompletedNot Applicable

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Virginia Commonwealth University1 site in 1 country10 target enrollmentStarted: January 24, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Retention of Participants

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
9 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •Must be English or Spanish speaking

Exclusion Criteria

  • •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
  • •Non-English or Non-Spanish speaking

Arms & Interventions

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.

Intervention: Virtual Health Coach (Behavioral)

Outcomes

Primary Outcomes

Retention of Participants

Time Frame: 6 months

Ability to retain 70% of participants at primary end point.

Recruitment of Participants.

Time Frame: 6 months

Percentage of participants recruited compared to goal sample size.

Number of Participants Who Reported Being Satisfied With the Intervention

Time Frame: 6 months

Measured in an exit interview. Participants were asked if they benefited from the program.

Secondary Outcomes

  • 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)
  • Parent Reported Sleep Duration for Child(Baseline, 3-month, and 6-month)
  • Home Food Environment.(Baseline, 3-, and 6-months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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