Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
NCT ID: NCT06078774
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2024-01-24
2024-08-16
Brief Summary
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Detailed Description
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Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Virtual Health Coach - Parent/Child Dyad
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.
Virtual Health Coach
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.
Interventions
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Virtual Health Coach
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
9 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Melanie Bean, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth Universiy
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HM20026673
Identifier Type: -
Identifier Source: org_study_id