Trial Outcomes & Findings for Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls (NCT NCT06078774)

Results Overview

Percentage of participants recruited compared to goal sample size.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2025-12-23

Participant Flow

Recruitment for the trial occurred from January 2024 through August 2024. Recruitment methods included physician referrals and direct patient messaging with the electronic health record.

Participant milestones

Participant milestones
Measure	Child Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent n=5 Participants Parents that participated in the Virtual Housecalls behavioral intervention with their child.	Total n=10 Participants Total of all reporting groups
Age, Continuous	12.2 years STANDARD_DEVIATION 1.8 • n=68 Participants	40.6 years STANDARD_DEVIATION 5.8 • n=4 Participants	26.4 years STANDARD_DEVIATION 15.5 • n=219 Participants
Sex: Female, Male Female	4 Participants n=68 Participants	5 Participants n=4 Participants	9 Participants n=219 Participants
Sex: Female, Male Male	1 Participants n=68 Participants	0 Participants n=4 Participants	1 Participants n=219 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=68 Participants	5 Participants n=4 Participants	10 Participants n=219 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Black or African American	3 Participants n=68 Participants	3 Participants n=4 Participants	6 Participants n=219 Participants
Race (NIH/OMB) White	1 Participants n=68 Participants	2 Participants n=4 Participants	3 Participants n=219 Participants
Race (NIH/OMB) More than one race	1 Participants n=68 Participants	0 Participants n=4 Participants	1 Participants n=219 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Region of Enrollment United States	5 participants n=68 Participants	5 participants n=4 Participants	10 participants n=219 Participants
Body Mass Index	25.99 kg/m^2 STANDARD_DEVIATION 3.22 • n=68 Participants	33.45 kg/m^2 STANDARD_DEVIATION 3.83 • n=4 Participants	29.72 kg/m^2 STANDARD_DEVIATION 5.16 • n=219 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The Overall Number of Participants Analyzed reflects the target enrollment number and the data reported reflects the actual number of participants enrolled.

Percentage of participants recruited compared to goal sample size.

Outcome measures

Outcome measures
Measure	Child n=50 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent n=50 Participants Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Recruitment of Participants.	5 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent n=5 Participants Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Retention of Participants	5 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only participants who participated in an exit interview were included in this outcome.

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

Outcome measures

Outcome measures
Measure	Child n=3 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent n=3 Participants Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Number of Participants Who Reported Being Satisfied With the Intervention	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent n=5 Participants Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Body Mass Index Change	1.07 kg/m^2 Standard Deviation 1.05	-0.43 kg/m^2 Standard Deviation 1.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Adolescent Reported Authoritative Parenting Style Baseline	26.80 units on a scale Standard Deviation 6.54	—
Adolescent Reported Authoritative Parenting Style 3-months	26.40 units on a scale Standard Deviation 2.41	—
Adolescent Reported Authoritative Parenting Style 6-months	27.60 units on a scale Standard Deviation 4.93	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Parent Reported Parenting Style Baseline	4.16 units on a scale Standard Deviation 0.51	—
Parent Reported Parenting Style 3-month	4.2 units on a scale Standard Deviation 0.69	—
Parent Reported Parenting Style 6-month	4.25 units on a scale Standard Deviation 0.71	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Dietary Intake Baseline	1606 kilocalories Standard Deviation 440	—
Dietary Intake 3-month	1997 kilocalories Standard Deviation 1143	—
Dietary Intake 6-month	1224 kilocalories Standard Deviation 385	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Physical Activity. Baseline	3.7 units on a scale Standard Deviation 1.6	—
Physical Activity. 3-month	4.3 units on a scale Standard Deviation 1.6	—
Physical Activity. 6-month	3.5 units on a scale Standard Deviation 1.3	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Parent Reported Sleep Duration for Child Baseline	8.45 hours Standard Deviation 1.12	—
Parent Reported Sleep Duration for Child 3-month	8.55 hours Standard Deviation 1.303	—
Parent Reported Sleep Duration for Child 6-month	9.10 hours Standard Deviation 0.96	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Child n=5 Participants Children that participated in the Virtual Housecalls behavioral intervention with their parent.	Parent Parents that participated in the Virtual Housecalls behavioral intervention with their child.
Home Food Environment. Baseline	15.40 units on a scale Standard Deviation 14.98	—
Home Food Environment. 3-month	10.60 units on a scale Standard Deviation 1.52	—
Home Food Environment. 6-month	11.20 units on a scale Standard Deviation 3.27	—

Adverse Events

Child

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Farthing

Virginia Commonwealth University

Phone: 804-527-4756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place