NCT03995394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

June 20, 2019

Last Update Submit

March 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Change from Baseline in Pediatric Quality of Life Inventory 4.0 (PedsQL) Survey (child self-report 13-18) at 6 Months

    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 Outcomes (2)

  • Mean Change from Baseline in Pediatric Quality of Life Inventory 4.0 (PedsQL) Survey (parent proxy report 13-18) at 6 Months

    6-month

  • Mean Change from Baseline in Body Mass Index (BMI)

    6-month

Study Arms (2)

Positive Reinforcement Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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."

Interventions

A text message comprising the words, "Great job! We're so proud of you! Keep up the good work!"

Positive Reinforcement Group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

  • Schwimmer JB, Burwinkle TM, Varni JW. Health-related quality of life of severely obese children and adolescents. JAMA. 2003 Apr 9;289(14):1813-9. doi: 10.1001/jama.289.14.1813.

    PMID: 12684360BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marsha Ma, M.D.

    Loyola University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 24, 2019

Study Start

June 18, 2019

Primary Completion

June 10, 2022

Study Completion

March 10, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations