Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: Weigh Smart Telehealth intervention

• Registration Number: NCT04521595
• Lead Sponsor: Johns Hopkins University

Brief Summary

There has been a steep rise in the prevalence of obesity among children and adults in the United States. The Weigh Smart program, a family based weight management program was developed in 2005 with significant improvement in the severity of obesity among children in the Baltimore are participating in the group program with limited impact outside the region due to transportation. Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the Eastern Shore and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. Investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit re: sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Detailed Description

. Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street to families of overweight and obese children between 7-17 years of age referred from selected pediatric practices on the Eastern Shore of Maryland and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit charge 3- steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. Investigators plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit charge 3 sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

Study Timeline

• Study Start: 2020-08-11
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
weigh smart intervention	Weigh Smart Telehealth intervention	open treatment arm to receive group based lifestyle intervention via telehealth.

Primary Outcome Measures

Name	Time	Method
Combined Weight change in parent and child	Up to 12 months	Comparison of combined weight of both child and parent at baseline to weight at 1,3,6 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Change in Pediatric Sleep Questionnaire (PSQ) sleep questionnaire in child	up to 12 months	This will assess the comparison of score at baseline to 3-6 months post-intervention. The PSQ contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric Obstructive Sleep Apnea features. It is a binary scale of 2 responses, YES=1 OR NO=0, therefore a maximum of 22 points and minimum of zero.

Trial Locations

Locations (1)

Mount Washington Pediatric Hospital; 🇺🇸 Baltimore, Maryland, United States