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

NCT04590846 | Completed

• 1 other identifier: JWang20-JZ01
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

Constipation

Keywords

constipation; Bristol Stool Scale; health educational intervention

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• The numbers of changing constipation status between 0-week and 4-week

  0-week, 4-week

• The numbers of changing constipation status between 0-week and 8-week

  0-week, 8-week

• The incidence rates of constipation at 4-week

  4-week

• The incidence rates of constipation at 8-week

  8-week

• The proportions of improved students at 4-week

  4-week

Study Arms (2)

Constipation Health Education

EXPERIMENTAL

Health education leaflets are distributed once a week, and students are asked to bring it back to their parents to read. The activity of "seeing leaflets, accumulating points, and redeeming prizes" is adopted. a reply slip is designed in the weekly health education content, containing 3-5 test questions. Parents need to complete the answers and sign after reading the health education content. Those who have a high degree of correctness and fully paid in within 4 weeks will receive additional points. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. The points of the parent health education receipt and the points of the children will be combined and calculated, and the weight will be set according to the total number of points for the draw.

Behavioral: Constipation Health Education Intervention Course; Behavioral: General Health Course

General Health Course

ACTIVE COMPARATOR

In order to correctly evaluate the effectiveness of health education intervention, only the parents of the experimental group will receive the health education leaflet during the intervention period. However, after the end of the trial, an electronic file of parental health education in the control group will be provided. Students are required to keep a " Stool diary record sheet " every day, and it will be posted in the contact book. Children who have confirmed records and turned in will get 10 points a week, and those who turned in all 8 weeks without random answers can get extra points. After the children's points are counted, a lottery will be drawn based on the total number of points. Since the experimental group and the control group have different benchmarks for points, the lottery will be drawn separately from each school. During the lottery process, the time will be announced in advance, and the number will be randomly selected by the computer in a live broadcast method.

Behavioral: General Health Course

Interventions

Constipation Health Education Intervention Course BEHAVIORAL

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.

Constipation Health Education

General Health Course BEHAVIORAL

General courses about health issues according to the curriculum of each primary school.

Constipation Health Education; General Health Course

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Asia University: lead

Study Sites (2)

Yunlin County Shuicanlin Elementary School

Yuanlin, 65241, Taiwan

Location

Raoping Elementary School

Yuanlin, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 30400292 BACKGROUND

• 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.

  PMID: 21354081 BACKGROUND

• 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.

  PMID: 30146529 BACKGROUND

• 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.

  PMID: 28049271 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jia-Zhen Li, MS

  Asia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: October 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)