Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078774

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Pediatric	Behavioral: Virtual Health Coach	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

BMI [6 months]
BMI change (kg/m2) for child and parent
Parenting assessed by child [6 months]
Parenting style and supports assessed in questionnaire: Authoritative Parenting Index (child measure)
Parenting assessed by parent [6 months]
Parenting style and supports assessed in questionnaires: Parenting Styles & Dimensions Questionnaire (parent measure)
Child diet [6 months]
Average total energy intake (kcal/day) estimated via recall
Physical activity. [6 months]
Engagement in physical activity self-reported by the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition (PACE+) questionnaire.
Sleep. [6 months]
Reported sleep time.
Home food environment. [6 months]
Foods found in the home and the storage of foods captured in the Home Food Inventory questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

Accepts 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