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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of Participants. | Percentage of participants recruited compared to goal sample size. | 6 months |
| Retention of Participants | Ability to retain 70% of participants at primary end point. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Adolescent Reported Authoritative Parenting Style |
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Inclusion Criteria:
Children:
Parent:
-Must be English or Spanish speaking
Exclusion Criteria:
Children:
Parent:
-Non-English or Non-Spanish speaking
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Bean, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth Universiy | Richmond | Virginia | 23298 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Child | Children that participated in the Virtual Housecalls behavioral intervention with their parent. |
| FG001 | Parent | Parents that participated in the Virtual Housecalls behavioral intervention with their child. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Child | Children that participated in the Virtual Housecalls behavioral intervention with their parent. |
| BG001 | Parent | Parents that participated in the Virtual Housecalls behavioral intervention with their child. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment of Participants. | Percentage of participants recruited compared to goal sample size. | The Overall Number of Participants Analyzed reflects the target enrollment number and the data reported reflects the actual number of participants enrolled. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Child | Children that participated in the Virtual Housecalls behavioral intervention with their parent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Farthing | Virginia Commonwealth University | 804-527-4756 | sarah.malone@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2023 | Nov 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2023 | Nov 20, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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, 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. | 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. | 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. | 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. | 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. | Baseline, 3-, and 6-months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Retention of Participants | Ability to retain 70% of participants at primary end point. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Number of Participants Who Reported Being Satisfied With the Intervention | Measured in an exit interview. Participants were asked if they benefited from the program. | Only participants who participated in an exit interview were included in this outcome. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | kg/m^2 | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3-, and 6-months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3-, and 6-months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kilocalories | Baseline, 3-, and 6-months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3-, and 6-months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours | Baseline, 3-month, and 6-month |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3-, and 6-months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Parent | Parents that participated in the Virtual Housecalls behavioral intervention with their child. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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