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

NCT04521595 | Completed

• 1 other identifier: IRB00251530
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• Combined Weight change in parent and child

  Comparison of combined weight of both child and parent at baseline to weight at 1,3,6 months post-intervention

  Up to 12 months

Secondary Outcomes (1)

• Change in Pediatric Sleep Questionnaire (PSQ) sleep questionnaire in child

  up to 12 months

Study Arms (1)

weigh smart intervention

EXPERIMENTAL

open treatment arm to receive group based lifestyle intervention via telehealth.

Behavioral: Weigh Smart Telehealth intervention

Interventions

Weigh Smart Telehealth intervention BEHAVIORAL

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. We plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.

weigh smart intervention

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are overweight/obese (7-17 years of age)
• Children must be referred by selected Maryland Eastern Shore and Western Maryland pediatric practices to Mount Washington Pediatric Hospital Weigh Smart. Families must provide informed consent at the weigh smart visit and have access to either a tablet, laptop or smart phone device to participate.

You may not qualify if:

• Children outside of the age range
• Children not seen by Maryland Eastern Shore or Western Maryland pediatric providers who are part of the intervention group
• Children who do not have internet access either by smart phone or tablet to allow telehealth participation
• Children who are unwilling to participate in group program and followup local visits

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Mount Washington Pediatric Hospital

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: August 11, 2020
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (1)