- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521595
Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth (Weigh Smart)
September 16, 2021 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21209
- Mount Washington Pediatric Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: weigh smart intervention
open treatment arm to receive group based lifestyle intervention via telehealth.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined Weight change in parent and child
Time Frame: Up to 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pediatric Sleep Questionnaire (PSQ) sleep questionnaire in child
Time Frame: 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.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2020
Primary Completion (Actual)
July 26, 2021
Study Completion (Actual)
July 26, 2021
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00251530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Pilot study at present.
Plan to present results once completed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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