Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Study Overview
=================
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 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.

Official Title
-----------------
Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Conditions
-----------------
Obesity, Pediatric

Intervention / Treatment
-----------------
* Behavioral: Virtual Health Coach


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Health Coach - Parent/Child Dyad<br>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. | Behavioral: Virtual Health Coach<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| Participant satisfaction | Measured by surveys. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI change (kg/m2) for child and parent | 6 months | 
| Parenting assessed by child | Parenting style and supports assessed in questionnaire: Authoritative Parenting Index (API) (child measure) with high scores indicating a high level of authoritative parenting behavior. | 6 months | 
| Parenting assessed by parent | Parenting style and supports assessed in questionnaires: Parenting Styles & Dimensions Questionnaire (parent measure) | 6 months | 
| Child diet | Average total energy intake (kcal/day) estimated via recall | 6 months | 
| Physical activity. | Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire. The higher the number reported represents more physical activity. | 6 months | 
| Sleep. | Reported sleep time. | 6 months | 
| Home food environment. | Foods found in the home and the storage of foods captured in the Home Food Inventory (HFI) questionnaire. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, House Calls, Pediatric Primary Care, Virtual, Telehealth