NCT06078774

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Completed NA Results posted Last updated 23 December 2025

What this trial tests

NA trial testing Virtual Health Coach in Obesity, Pediatric in 10 participants. Completed in 16 August 2024.

Timeline

24 January 2024

Primary endpoint
16 August 2024

16 August 2024

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	24 January 2024
Primary completion	16 August 2024
Estimated completion	16 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Virtual Health Coach

Conditions studied

• Obesity, Pediatric — all drugs for Obesity, Pediatric →

Sponsor

Virginia Commonwealth University

Who can join

9 and older, any sex, with Obesity, Pediatric. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment of Participants. Primary · 6 months

Percentage of participants recruited compared to goal sample size.

Group	Value	95% CI
Child	5
Parent	5

Retention of Participants Primary · 6 months

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

Group	Value	95% CI
Child	5
Parent	5

Number of Participants Who Reported Being Satisfied With the Intervention Primary · 6 months

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

Group	Value	95% CI
Child	3
Parent	3

Body Mass Index Change Secondary · 6 months

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).

Group	Value	95% CI
Child	1.07	± 1.05
Parent	-0.43	± 1.18

Adolescent Reported Authoritative Parenting Style Secondary · Baseline, 3-, and 6-months

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

Group	Value	95% CI
Child	26.80	± 6.54

3-months

Group	Value	95% CI
Child	26.40	± 2.41

6-months

Group	Value	95% CI
Child	27.60	± 4.93

Parent Reported Parenting Style Secondary · Baseline, 3-, and 6-months

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

Group	Value	95% CI
Parent	4.16	± 0.51

3-month

Group	Value	95% CI
Parent	4.2	± 0.69

6-month

Group	Value	95% CI
Parent	4.25	± 0.71

Dietary Intake Secondary · Baseline, 3-, and 6-months

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

Group	Value	95% CI
Child	1606	± 440

3-month

Group	Value	95% CI
Child	1997	± 1143

6-month

Group	Value	95% CI
Child	1224	± 385

Physical Activity. Secondary · Baseline, 3-, and 6-months

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

Group	Value	95% CI
Child	3.7	± 1.6

3-month

Group	Value	95% CI
Child	4.3	± 1.6

6-month

Group	Value	95% CI
Child	3.5	± 1.3

Parent Reported Sleep Duration for Child Secondary · Baseline, 3-month, and 6-month

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

Group	Value	95% CI
Child	8.45	± 1.12

3-month

Group	Value	95% CI
Child	8.55	± 1.303

6-month

Group	Value	95% CI
Child	9.10	± 0.96

Home Food Environment. Secondary · Baseline, 3-, and 6-months

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

Group	Value	95% CI
Parent	15.40	± 14.98

3-month

Group	Value	95% CI
Parent	10.60	± 1.52

6-month

Group	Value	95% CI
Parent	11.20	± 3.27

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.