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

Constipation Clinical Trial

Official title:

The Effectiveness of a Caregiver-mediated Health Educational Intervention on Improving Constipation Among Primary School Children and the Knowledge and Attitude Toward Constipation Among Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590846
• Other study ID #: JWang20-JZ01
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2022
• Source: Asia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• Constipation Health Education Intervention Course
The 4-weeks health education includes three dimensions. The first is "Causes and Hazards of Constipation". The second is "Constipation Symptoms and Criteria". The third is "Constipation Treatment Strategies and Prevention". Health education leaflets with 3 to 5 test questions in the weekly are distributed once a week, students will bring them back to parents, and parents need to complete the answers and sign after reading them.
• General Health Course
General courses about health issues according to the curriculum of each primary school.

Locations

Country	Name	City	State
Taiwan	Raoping Elementary School	Yuanlin
Taiwan	Yunlin County Shuicanlin Elementary School	Yuanlin

Sponsors (1)

Lead Sponsor	Collaborator
Asia University

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Asakura K, Masayasu S, Sasaki S. Dietary intake, physical activity, and time management are associated with constipation in preschool children in Japan. Asia Pac J Clin Nutr. 2017 Jan;26(1):118-129. doi: 10.6133/apjcn.112015.02. — View Citation

Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11). pii: E1650. doi: 10.3390/nu10111650. — View Citation

Wu TC, Chen LK, Pan WH, Tang RB, Hwang SJ, Wu L, Eugene James F, Chen PH. Constipation in Taiwan elementary school students: a nationwide survey. J Chin Med Assoc. 2011 Feb;74(2):57-61. doi: 10.1016/j.jcma.2011.01.012. — View Citation

Yamada M, Sekine M, Tatsuse T. Psychological Stress, Family Environment, and Constipation in Japanese Children: The Toyama Birth Cohort Study. J Epidemiol. 2019 Jun 5;29(6):220-226. doi: 10.2188/jea.JE20180016. Epub 2018 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of parents' knowledge towards constipation related issues between 0-week and 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.	0-week, 4-week
Primary	The change of parents' attitude towards constipation related issues between 0-week and 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.	0-week, 4-week
Primary	The change of parents' behavior intention towards constipation related issues between 0-week and 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.	0-week, 4-week
Secondary	The numbers of changing constipation status between 0-week and 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.	0-week, 4-week
Secondary	The numbers of changing constipation status between 0-week and 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.	0-week, 8-week
Secondary	The incidence rates of constipation at 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).	4-week
Secondary	The incidence rates of constipation at 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).	8-week
Secondary	The proportions of improved students at 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".	4-week
Secondary	The proportions of improved students at 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".	8-week