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Completed

NCT Number: NCT04521595

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

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.

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Key information

Conditions

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

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Washington Pediatric Hospital

Baltimore, Maryland, 21209, United States

About this study

. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: Weigh Smart

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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