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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weigh Smart Telehealth intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Sites / Locations

  • Mount Washington Pediatric Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

weigh smart intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2020
Last Updated
September 16, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04521595
Brief Title
Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth
Acronym
Weigh Smart
Official Title
Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weigh smart intervention
Arm Type
Experimental
Arm Description
open treatment arm to receive group based lifestyle intervention via telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Weigh Smart Telehealth intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined Weight change in parent and child
Description
Comparison of combined weight of both child and parent at baseline to weight at 1,3,6 months post-intervention
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Change in Pediatric Sleep Questionnaire (PSQ) sleep questionnaire in child
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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
Facility Information:
Facility Name
Mount Washington Pediatric Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Pilot study at present. Plan to present results once completed

Learn more about this trial

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

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