Text Messaging Pediatric Obese Patients

March 14, 2025 updated by: Marsha Ma

Use of Text Messaging for Positive Reinforcement to Help Improve Quality of Life in Pediatric Obese Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a prospective interventional cohort study following a group of participants with obesity. Informed consent will be obtained from the parents from a member of the research committee. Informed assent will also be obtained from the participant from a member of the research committee.

The investigators will review the schedule in the pediatrics department daily and approach all participants that meet our inclusion criteria. Per standard of care for participants with obesity, the participants have a scheduled follow up for a weight check at regular intervals that can include one month, 3 months or 6 months.

The 40 participants will be randomly assigned to either a control group or an intervention group.

Survey:

A 23 item PedsQL 4.0 pre-survey will be administered to pediatric participants to establish a baseline at their wellness visits. The parent of the participant will also be given a PedsQL survey to fill out. The participants' Body Mass Index (BMI) and blood pressure will be recorded. At the end of the 6-month period, the same PedsQL 4.0 will be administered again to both the participant and parent at the scheduled 6-month weight check that is standard of care.

The investigators will use a text message application created by the Loyola informatics team. This application will be able to text the participants using their cell phone number via an email service from the provider. For example, 123456789@cellservice provider.com. This allows the research team to send text messages to be sent through an application without using a personal phone number. In addition, it offers automatic responses that will save them when sending messages to the participant.

For six months, participants in the study will receive a text message twice per week via this application.

Text messaging:

There will be two groups within this study-a control group and an intervention group. For the control group, participants will receive two text messages weekly. The first text message will ask if the participants have completed the recommended activity. When a participant responds, the participant will receive a second text message stating, "Thanks for your response."

In the intervention group, the first text message will ask if the participant completed the recommended activity. If the participant responds yes, the participant will receive a positive reinforcement response comprising the words "Great job! We're so proud of you! Keep up the good work!". If the participant responds no, the participant will receive a text message stating, "Thank you for your response."

Study Activities:

The weekly activities the investigators will recommend for the participants include:

  1. Walking for 30 minutes 3 times a week
  2. Speed walk for 30 minutes 3 times a week
  3. Walk up and down stairs for 30 minutes 3 times a week
  4. Jogging for 30 minutes 3 times a week
  5. Jumping jacks for 30 minute 3 times a week

Data:

All participant data will be stored in a protected Data-base, REDcap.

Statistical analysis:

In this study, participants who are age 18 and under with a BMI in at least the 95th percentile will be asked to complete assigned exercises. For six months, these participants will receive a text message twice per week asking whether the participant has completed the assigned exercises. For participants marking "Yes", exactly one half will be randomized to receive a positive reinforcement response comprising the words "Great job! We're so proud of you! Keep up the good work!". The other half will receive a control response comprising the words "Thanks for your response"; all participants marking "No" will receive this same response. The study will use a 1:1 allocation.

Six months following randomization, one goal of the proposed study is to test the null hypothesis that average total score on PedsQL 4.0 questionnaire between the two groups are equal. With a proposed sample size of 20 assigned to receive the positive reinforcement response and 20 assigned to receive the control response (N = 40), the study will have power of 80.0 percent to yield a statistically significant result. This computation assumes a mean difference between the two cohorts of 14.8 points (corresponding to means of 81.8 for the positive reinforcement cohort and 67.0 for the control response cohort) and a common within-group standard deviation of 16.3 points (Schwimmer, et al.). This computation also assumes the criterion for significance (alpha) is 0.05 and that the test will be 2-tailed, meaning an effect in either direction will be interpreted.

Recommended Protocol Text for the Analysis Plan:

Participants under age 18 with a BMI in at least the 95th percentile will be asked to complete assigned exercises and will receive text messages asking the participants if the participant has completed such exercises. At baseline and the end of the study, the participants will complete the 23-item PedsQL 4.0 assessment. For each participant, the baseline value will be subtracted from the 6-month value. An independent samples t-test will be used to compare this delta score between the cohort assigned to receive the positive reinforcement response and the cohort assigned to receive the control response. For this comparison, the normal distribution assumption of the delta score will be assessed using QQ plots and outliers will be assessed using box plots. The homogeneity of variances assumption will be assessed using Levene's test. If any parametric assumption is strongly violated, a non-parametric Wilcoxon rank-sum test may be used to compare ranked PedsQL 4.0 scores between the two cohorts. All analyses will be completed using SAS version 9.4 (Cary, NC) by a Biostatistician in the Clinical Research Office.

Safety Monitoring Plan:

There are no adverse events that could be associated with text messages the investigators will send to the participants. The investigators will send these text messages on Monday early evening between the 5pm to 6pm. The investigators chose this time because participants will not be in school and are unlikely to be driving or doing activities that the participants could be distracted from when receiving the text, which could cause harm.

If there is an adverse effect, the investigators will ask the participants to notify the principal investigator of the project. The investigators will review safety information once a month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marsha Ma, M.D.
  • Phone Number: 708-327-9131
  • Email: tema@lumc.edu

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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."

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6-month
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.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marsha Ma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marsha Ma, M.D., Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 211950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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