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Text Messaging Pediatric Obese Patients

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ClinicalTrials.gov Identifier: NCT03995394
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marsha Ma, Loyola University

Brief Summary:
This study hopes to investigate the relationship between positive reinforcement for exercise activities in pediatric obese participants and quality of life. The investigators hypothesize that providing positive reinforcement through text messaging to children living with obesity will improve their overall quality of life. The investigators will recruit pediatric obese participants and administer a pre and post survey regarding quality of life. The family will be given recommendations on various ways to increase physical activity weekly. These participants will then receive positive reinforcement for completed exercises through text messages.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Other: Positive Reinforcement Text Message Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Use of Text Messaging for Positive Reinforcement to Help Improve Quality of Life in Pediatric Obese Patients
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 10, 2020

Arm Intervention/treatment
Experimental: Positive Reinforcement Group
In the intervention group, participants will receive two text messages weekly. The first text message will ask if participants completed the recommended activity. If the participants respond yes, the participant will receive a positive reinforcement response. If the participants respond no, the participant will receive a text message stating, "Thank you for your response."
Other: Positive Reinforcement Text Message
A text message comprising the words, "Great job! We're so proud of you! Keep up the good work!"

No Intervention: Control Group
For the control group, participants will receive two text messages weekly. The first text message will ask if the participants completed the recommended activity. When the participant responds, the participant will receive a second text message stating, "Thanks for your response."



Primary Outcome Measures :
  1. Mean Change from Baseline in Pediatric Quality of Life Inventory 4.0 (PedsQL) Survey (child self-report 13-18) at 6 Months [ Time Frame: 6-month ]
    This is a measurement of the participant's reported health-related quality of life while living with pediatric obesity. It is a multidimensional, 23-item survey measuring core elements of health, physical, emotional, social, and school functioning. The survey is a 5-point Likert scale from 0 (Never) to 4 (Almost always) and the scores are transformed on a scale from 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The mean score is the sum of the items over the number of items answered. The total score is the sum of all the items over the number of items answered on all the scales. Higher scores will indicate better health related quality of life. Lower scores will indicate worse health related quality of life.


Secondary Outcome Measures :
  1. Mean Change from Baseline in Pediatric Quality of Life Inventory 4.0 (PedsQL) Survey (parent proxy report 13-18) at 6 Months [ Time Frame: 6-month ]
    This is a measurement of the parent's perspective of the health-related quality of life of their child living with pediatric obesity. It is a multidimensional, 23-item survey measuring core elements of health, physical, emotional, social, and school functioning. The survey is a 5-point Likert scale from 0 (Never) to 4 (Almost always) and the scores are transformed on a scale from 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The mean score is the sum of the items over the number of items answered. The total score is the sum of all the items over the number of items answered on all the scales. Higher scores will indicate better health related quality of life. Lower scores will indicate worse health related quality of life.

  2. Mean Change from Baseline in Body Mass Index (BMI) [ Time Frame: 6-month ]
    This is a measurement of the participant's scheduled 6 month weight check that is the standard of care in pediatric obese patients.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) >95th percentile
  • Has a cell phone

Exclusion Criteria:

  • Developmental delay and inability to read
  • Does not have a cell phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995394


Contacts
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Contact: Marsha Ma, M.D. 708-327-9131 tema@lumc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Marsha Ma, M.D.    708-327-9131    tema@lumc.edu   
Sponsors and Collaborators
Marsha Ma
Investigators
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Principal Investigator: Marsha Ma, M.D. Loyola University
  Study Documents (Full-Text)

Documents provided by Marsha Ma, Loyola University:
Informed Consent Form  [PDF] June 13, 2019


Publications:
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Responsible Party: Marsha Ma, Principal Investigator, Loyola University
ClinicalTrials.gov Identifier: NCT03995394     History of Changes
Other Study ID Numbers: 211950
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms