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Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Primary Purpose

Obesity, Pediatric

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Health Coach
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Pediatric focused on measuring Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children: Ages 9-13 years BMI 85th to <99th percentile Must be a patient within CHoR 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Virtual Health Coach - Parent/Child Dyad

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    To test the recruitment feasibility of the Virtual HouseCalls intervention.
    recruitment/enrollment (target sample met)
    To test the retention feasibility of the Virtual HouseCalls intervention.
    retention of participants (at least 70% at 6m)
    To test the participant satisfaction feasibility of the Virtual HouseCalls intervention.
    participant satisfaction (as measured by exit surveys)

    Secondary Outcome Measures

    BMI
    BMI change (kg/m2) for child and parent
    Parenting assessed by child
    Parenting style and supports assessed in questionnaire: Authoritative Parenting Index (child measure)
    Parenting assessed by parent
    Parenting style and supports assessed in questionnaires: Parenting Styles & Dimensions Questionnaire (parent measure)
    Child diet
    Average total energy intake (kcal/day) estimated via recall
    Physical activity.
    Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire.
    Sleep.
    Reported sleep time.
    Home food environment.
    Foods found in the home and the storage of foods captured in the Home Food Inventory questionnaire.

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06078774
    Brief Title
    Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
    Official Title
    Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 real-time within the home environment.
    Detailed Description
    Investigators will recruit children with an elevated 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Pediatric
    Keywords
    Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Health Coach - Parent/Child Dyad
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Health Coach
    Intervention Description
    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 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 Outcome Measure Information:
    Title
    To test the recruitment feasibility of the Virtual HouseCalls intervention.
    Description
    recruitment/enrollment (target sample met)
    Time Frame
    6 months
    Title
    To test the retention feasibility of the Virtual HouseCalls intervention.
    Description
    retention of participants (at least 70% at 6m)
    Time Frame
    6 months
    Title
    To test the participant satisfaction feasibility of the Virtual HouseCalls intervention.
    Description
    participant satisfaction (as measured by exit surveys)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    BMI
    Description
    BMI change (kg/m2) for child and parent
    Time Frame
    6 months
    Title
    Parenting assessed by child
    Description
    Parenting style and supports assessed in questionnaire: Authoritative Parenting Index (child measure)
    Time Frame
    6 months
    Title
    Parenting assessed by parent
    Description
    Parenting style and supports assessed in questionnaires: Parenting Styles & Dimensions Questionnaire (parent measure)
    Time Frame
    6 months
    Title
    Child diet
    Description
    Average total energy intake (kcal/day) estimated via recall
    Time Frame
    6 months
    Title
    Physical activity.
    Description
    Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire.
    Time Frame
    6 months
    Title
    Sleep.
    Description
    Reported sleep time.
    Time Frame
    6 months
    Title
    Home food environment.
    Description
    Foods found in the home and the storage of foods captured in the Home Food Inventory questionnaire.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children: Ages 9-13 years BMI 85th to <99th percentile Must be a patient within CHoR 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Farthing
    Phone
    804-527-4756
    Email
    sarah.malone@vcuhealth.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shari Barkin
    Email
    Shari.Barkin@vcuhealth.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melanie Bean, PhD
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

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