Obesity, PediatricNCT06078774
Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
A study testing Virtual Health Coach in people with Obesity, Pediatric, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Obesity, Pediatric
- What is being tested?
- Virtual Health Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth Universiy
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Obesity, Pediatric
- Being tested
- Virtual Health Coach
- Keywords
- Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Health CoachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Health Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of Participants.
Percentage of participants recruited compared to goal sample size.
Measured: 6 months
Retention of Participants
Ability to retain 70% of participants at primary end point.
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
Body Mass Index Change
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).
Measured: 6 months
Adolescent Reported Authoritative Parenting Style
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.
Measured: Baseline, 3-, and 6-months
Parent Reported Parenting Style
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.
Measured: Baseline, 3-, and 6-months
Dietary Intake
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.
Measured: Baseline, 3-, and 6-months
Physical Activity.
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.
Measured: Baseline, 3-, and 6-months
Parent Reported Sleep Duration for Child
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.
Measured: Baseline, 3-month, and 6-month
Home Food Environment.
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.
Measured: Baseline, 3-, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start24 Jan 2024
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, PediatricStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Bean, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078774
- Sponsor's protocol ID
- HM20026673
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2023
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
- ClinicalTrials.gov ID
- NCT06078774
- Acronym / sponsor ID
- HM20026673
- Conditions
- Obesity, Pediatric
- Keywords
- Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Health Coach - Parent/Child Dyad | Experimental | Behavioral: Virtual Health CoachFocuses 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. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Health CoachDyads 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. | Behavioural | Virtual Health Coach - Parent/Child Dyad |
Primary outcome
Recruitment of Participants.
Time frame: 6 months
Percentage of participants recruited compared to goal sample size.
Retention of Participants
Time frame: 6 months
Ability to retain 70% of participants at primary end point.
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.
7 secondary outcomes
Body Mass Index Change
Time frame: 6 months
Adolescent Reported Authoritative Parenting Style
Time frame: Baseline, 3-, and 6-months
Parent Reported Parenting Style
Time frame: Baseline, 3-, and 6-months
Dietary Intake
Time frame: Baseline, 3-, and 6-months
Physical Activity.
Time frame: Baseline, 3-, and 6-months
Parent Reported Sleep Duration for Child
Time frame: Baseline, 3-month, and 6-month
Home Food Environment.
Time frame: Baseline, 3-, and 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Bean, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Health Coach in people with Obesity, Pediatric, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of Participants. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.