Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Constipation
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a quasi-experimental design study, which will enroll students in the 3rd to 6th grades of two primary schools and their parents in Yunlin. There will be 200 children in the experimental group and 200 in the control group; with a total of 400 students and their parents. Parents in the experimental group will receive health educational leaflets every week. No intervention will be given to the control group. The 4-weeks intervention is scheduled to be from September to November 2020. Both the experimental and control groups will be asked to fill up a questionnaire at the before and after the intervention. The questionnaire includes the defecation and constipation situation of children, physical activity, dietary behavior, life pressure, and parents' knowledge and attitude toward constipation. Both groups of children have to fill out the Stool diary record sheet once a week, including the intervention period and the follow-up period for a total of 8 weeks.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 10 years and 13 years
Gender
Both males and females

Description

Background and Purposes: Constipation among children is a global health issue. It can distribute a significant impact on medical, social, and economic dimensions, and can delay children's growth. Without proper treatments on constipation, it would reduce the cure rate and increase recurrence rate. E...

Background and Purposes: Constipation among children is a global health issue. It can distribute a significant impact on medical, social, and economic dimensions, and can delay children's growth. Without proper treatments on constipation, it would reduce the cure rate and increase recurrence rate. Early diagnosis can improve the prognosis of functional constipation. Only a few studies of children constipation are available in the literature, so it is critical to investigate the topic of constipation among children. Methods: This is a quasi-experimental design study, which will enroll students in the 3rd to 6th grades of two primary schools and their parents in Yunlin. There will be 200 children in the experimental group and 200 in the control group; a total of 400 students and their parents. Parents in the experimental group will receive health educational leaflets every week and students will have to record the situation of defecation once a week. No intervention will be given to the control group. The 4-weeks intervention is scheduled to be from September to November 2020, with a total of 8 weeks. Both the experimental and control groups will be asked to fill up a questionnaire at the before and after the intervention. The questionnaire includes the defecation and constipation situation of children, physical activity, dietary behavior, life pressure, and parents' knowledge and attitude toward constipation. Both groups of children have to fill out the Stool diary record sheet, including the intervention period and the follow-up period for a total of 8 weeks Children with the first and second types of the Bristol Stool Scale will be defined as constipation. Expected results: The study can provide the understanding of the current status of constipation in primary school children, parents' awareness and attitudes on constipation-related issues. Besides, through the study, a simple and feasible health educational program for parents of primary school children will be proposed, and the efficacy of the program will be evaluated.

Tracking Information

NCT #
NCT04590846
Collaborators
Not Provided
Investigators
Study Director: Jia-Zhen Li, MS Asia University