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临床试验/NCT03995394
NCT03995394已完成不适用

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

Marsha Ma2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Mean Change from Baseline in Pediatric Quality of Life Inventory 4.0 (PedsQL) Survey (child self-report 13-18) at 6 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Marsha Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marsha Ma

Principal Investigator

Loyola University

研究点 (2)

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