跳至主要内容
临床试验/NCT06934083
NCT06934083已完成不适用

A Novel Family E-Health Intervention Process To Reduce Childhood Obesity

University of North Texas Health Science Center2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Motivation in units of scale measure

研究概览

简要总结

Participants will receive text messages at intervals set by preference but at least 2 times per week relating to Lifestyle Health Education for 6 months. The topics to be reviewed include: Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection. Participants will be asked to complete surveys regarding these topics at the beginning and end of the week; in addition, participants will self report to the study team vital signs (including blood pressure, blood glucose, total cholesterol, waist circumference, and body mass index (BMI)) at the beginning and end of the study. Although there is a chance participants may encounter some issues with the study procedures (possible breach of confidentiality, or issues with the study procedures), these risks are minimal. The study team will always keep information secure, and participants may decline to participate in any study procedures, or withdraw from the study, at any time.

One benefit from this study may be that participants may improve their overall health by learning more about healthy eating, improved physical activity, limiting/avoiding tobacco intake, improved sleep patterns, adequate stress management, and better social connection. Participation in this study is not required.

详细描述

Participants will be randomized (like the flip of coin) to one of two study groups. Based on the group assigned, participants will receive text messages which include either: 1) reminders of health education available through the patient portal of the electronic medical record for participant's child, or 2) briefs on six health education topics: nutrition, physical activity, sleep, tobacco avoidance, stress management, and social connection. No matter which group assigned, participants will attend one live or virtual group meeting to close the study.

For both groups, researchers will measure knowledge, attitudes and health habits before and after the program. Researchers will also request self-reports of health status (height, weight, waist size, Body Mass Index (BMI), blood pressure, blood sugar, and total cholesterol). Participants will provide the researchers with estimates of most recent blood pressure, total cholesterol, and blood glucose test if known. The study will include text message briefs received at least twice weekly for six months, and will include the following measures:

  • General information (e.g., age, gender, education)
  • Health knowledge & attitudes (e.g., heart disease, diabetes) & healthy lifestyle practices (e.g., diet, exercise)
  • Health status (e.g., Blood pressure, BMI, etc.) The study team estimate that 142 people will enroll in the study.

For both groups, the following will be measured at the first visit (also called the "baseline visit" completed at the time of enrollment) and also at the last visit (during the live or virtual community celebration):

  • Participant's health status (height, weight, waist size, Body Mass Index (BMI), blood pressure, blood sugar, and total cholesterol).
  • Survey of knowledge, attitudes and health habits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • family member has a child who is a current or former patient of Pediatric Mobile Clinic with a medical diagnosis of overweight/obese,
  • defined as BMI percentile of 85% or above,
  • age of the child is 6 months to 11 years old,
  • family member is a primary caregiver to the child,
  • family member over the age of 18 years,
  • family member is not currently pregnant, and
  • family member has a cell phone with Short Message Service (SMS) text message capability.

排除标准

  • family member has a terminal illness.

结局指标

主要结局

Motivation in units of scale measure

时间窗: 12 months

10-point Likert scale (minimum of 1, maximum of 10, 10 representing highest level of motivation) of transtheoretical stage of change used to assess motivation to achieve participant derived SMART goal each week for 6 months then at 3-month intervals for 2 follow-up check-ins.

次要结局

  • Confidence in units of scale measure(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验