Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Obesity, Pediatric Clinical Trial

Official title:

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06078774
• Other study ID #: HM20026673
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Pediatric
• Pediatric Obesity

Intervention

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 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth Universiy	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of participants.	Percentage of participants recruited compared to goal sample size.	6 months
Primary	Retention of participants	Ability to retain 70% of participants at primary end point.	6 months
Primary	Participant satisfaction	Measured by surveys.	6 months
Secondary	BMI	BMI change (kg/m2) for child and parent	6 months
Secondary	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
Secondary	Parenting assessed by parent	Parenting style and supports assessed in questionnaires: Parenting Styles & Dimensions Questionnaire (parent measure)	6 months
Secondary	Child diet	Average total energy intake (kcal/day) estimated via recall	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 higher the number reported represents more physical activity.	6 months
Secondary	Sleep.	Reported sleep time.	6 months
Secondary	Home food environment.	Foods found in the home and the storage of foods captured in the Home Food Inventory (HFI) questionnaire.	6 months