A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children

Not Applicable

Completed

• Conditions: Constipation

• Registration Number: NCT04590846
• Lead Sponsor: Asia University

Brief Summary

The research adopts caregiver-mediated health educational intervention to Improve constipation status of primary school children. It 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 County. There will be 200 children in the experimental group and 200 in the control group. Parents in the experimental group will receive health educational leaflets every week and no intervention will be given to the control group. Both the experimental and control groups students will be asked to fill up a questionnaire at the before and after the intervention with a total of 8 weeks. The study can provide the understanding of the current status of constipation in primary school children, parents' awareness and attitudes on constipation-related issues.

Detailed 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. 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.

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-11
• Study First Posted: 2020-10-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Children with grades 3~6 in general classes of primary schools and their primary caregivers

Exclusion Criteria

• (1) Students who have mild or more server mental disabilities.
• (2) Suspected children with mild cognitive impairment who are receiving resource class services.
• (3) Due to congenital structure, endocrine, small intestinal nerve or muscle abnormalities, abdominal muscle tissue, connective tissue abnormalities, neurological abnormalities, such as irritable bowel syndrome, Hirschsprung disease, milk allergy (lactose intolerance), lupus erythematosus School children in other situations.
• (4) Children with gastrointestinal-related diseases caused by acquired factors such as heavy metals, vitamin D poisoning, drugs, etc.
• (5) School children with intestinal paralysis or slow transmission problems, such as hypothyroidism, hypokalemia, and anal sphincter damage.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change of parents' behavior intention towards constipation related issues between 0-week and 4-week	0-week, 4-week	The research tool used in this study is a self-compiled scale of behavior intention in the questionnaire. There are 4 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 4 to 20. A higher score indicates more stronger behavioral intentions for constipation improvement and prevention of a participant.
The change of parents' knowledge towards constipation related issues between 0-week and 4-week	0-week, 4-week	The research tool used in this study is a self-compiled scale of knowledge in the questionnaire. There are 15 items in the scale. For each item, the scoring is 1 or 0 depending on whether a participant's answer is correct or incorrect. Thus the score of this scale ranges from 0 to 15. The higher the score, the better the participant's knowledge of constipation.
The change of parents' attitude towards constipation related issues between 0-week and 4-week	0-week, 4-week	The research tool used in this study is a self-compiled scale of attitude in the questionnaire. There are 10 items in the scale. Likert 5-point scale is used for each item, with 1 representing strongly disagree and 5 strongly agree. Thus the score of this scale ranges from 10 to 50. A higher score indicates more positive attitude for constipation improvement and prevention of a participant.

Secondary Outcome Measures

Name	Time	Method
The incidence rates of constipation at 8-week	8-week	Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared at the follow-up time-point (8-week).
The proportions of improved students at 4-week	4-week	Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared after the intervention (4-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".
The proportions of improved students at 8-week	8-week	Regarding the students with constipation at the baseline (0-week) in the two groups, the proportions of students with improved status in the two groups will be compared at the follow-up time-point (8-week). Students with constipation at the baseline and becoming free of constipation will be considered "improved".
The incidence rates of constipation at 4-week	4-week	Regarding the students without constipation at the baseline (0-week) in the two groups, the incidence rates of constipation in the two groups will be compared after the intervention (4-week).
The numbers of changing constipation status between 0-week and 4-week	0-week, 4-week	The numbers of changing constipation status from yes to no and from no to yes between 0-week and 4-week will be recorded and compared.
The numbers of changing constipation status between 0-week and 8-week	0-week, 8-week	The numbers of changing constipation status from yes to no and from no to yes between 0-week and 8-week will be recorded and compared.

Trial Locations

Locations (2)

Yunlin County Shuicanlin Elementary School; 🇨🇳 Yuanlin, Taiwan

Raoping Elementary School; 🇨🇳 Yuanlin, Taiwan