Skip to main content
OpenTrials
Completed

NCT Number: NCT06078774

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth Universiy

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment of Participants.

    Time frame: 6 months

    Percentage of participants recruited compared to goal sample size.

  2. Retention of Participants

    Time frame: 6 months

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

  3. 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

  1. Body Mass Index Change

    Time frame: 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).

  2. Adolescent Reported Authoritative Parenting Style

    Time frame: 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.

  3. Parent Reported Parenting Style

    Time frame: 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.

  4. Dietary Intake

    Time frame: 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.

  5. Physical Activity.

    Time frame: 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.

  6. Parent Reported Sleep Duration for Child

    Time frame: 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.

  7. Home Food Environment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.