Clinical trial NCT04590846: A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
Bristol Stool Scale
health educational intervention
Lead sponsor: Asia University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 173
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of parents' knowledge towards constipation related issues between 0-week and 4-week
timeFrame: 0-week, 4-week
measure: The change of parents' attitude towards constipation related issues between 0-week and 4-week
timeFrame: 0-week, 4-week
measure: The change of parents' behavior intention towards constipation related issues between 0-week and 4-week
timeFrame: 0-week, 4-week
Secondary outcomes:
measure: The numbers of changing constipation status between 0-week and 4-week
timeFrame: 0-week, 4-week
measure: The numbers of changing constipation status between 0-week and 8-week
timeFrame: 0-week, 8-week
measure: The incidence rates of constipation at 4-week
timeFrame: 4-week
measure: The incidence rates of constipation at 8-week
timeFrame: 8-week
measure: The proportions of improved students at 4-week
timeFrame: 4-week
measure: The proportions of improved students at 8-week
timeFrame: 8-week
Other outcomes:
Locations:
city: Yuanlin
country: Taiwan
facility: Yunlin County Shuicanlin Elementary School
city: Yuanlin
country: Taiwan
facility: Raoping Elementary School
Study officials:
affiliation: Asia University
name: Jia-Zhen Li, MS
role: STUDY_DIRECTOR
References:
citation: Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650.
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.
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.
citation: 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.