ConstipationNCT04590846
A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children
A study testing Constipation Health Education Intervention Course and General Health Course in people with Constipation, run by Asia University at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Constipation Health Education Intervention Course and General Health Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesTaiwan
- Study dates
- 7 Oct 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with grades 3~6 in general classes of primary schools and their primary caregivers
Who cannot join
- (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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Yunlin County Shuicanlin Elementary School
Yuanlin, 65241
Raoping Elementary School
Yuanlin
About this study
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
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Constipation Health Education Intervention Course, General Health Course
- Keywords
- constipation, Bristol Stool Scale, health educational intervention
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constipation Health Education Intervention CourseBehavioural
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 CourseBehavioural
General courses about health issues according to the curriculum of each primary school.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General Health Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-week, 4-week
Secondary outcomes (6)
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.
Measured: 0-week, 4-week
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.
Measured: 0-week, 8-week
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).
Measured: 4-week
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).
Measured: 8-week
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".
Measured: 4-week
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".
Measured: 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia-Zhen Li, MS, Study director, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590846
- Sponsor's protocol ID
- JWang20-JZ01
- Status last verified
- Jul 2022
- First submitted
- 11 Oct 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30400292Wu 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.
PubMed 21354081Yamada 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.
PubMed 30146529Asakura 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.
PubMed 28049271
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04590846
- Acronym / sponsor ID
- JWang20-JZ01
- Conditions
- Constipation
- Keywords
- constipation, Bristol Stool Scale, health educational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Constipation Health Education | Experimental | Behavioral: Constipation Health Education Intervention Course, Behavioral: General Health CourseHealth 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. |
| General Health Course | Active comparator | Behavioral: General Health CourseIn 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. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with grades 3~6 in general classes of primary schools and their primary caregivers
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constipation Health Education Intervention CourseThe 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. | Behavioural | Constipation Health Education |
| General Health CourseGeneral courses about health issues according to the curriculum of each primary school. | Behavioural | Constipation Health Education, General Health Course |
Primary outcome
The change of parents' knowledge towards constipation related issues between 0-week and 4-week
Time frame: 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
Time frame: 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.
The change of parents' behavior intention towards constipation related issues between 0-week and 4-week
Time frame: 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.
6 secondary outcomes
The numbers of changing constipation status between 0-week and 4-week
Time frame: 0-week, 4-week
The numbers of changing constipation status between 0-week and 8-week
Time frame: 0-week, 8-week
The incidence rates of constipation at 4-week
Time frame: 4-week
The incidence rates of constipation at 8-week
Time frame: 8-week
The proportions of improved students at 4-week
Time frame: 4-week
The proportions of improved students at 8-week
Time frame: 8-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 30400292Axelrod 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.
- Background: PubMed 21354081Wu 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.
- Background: PubMed 30146529Yamada 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.
- Results publication: PubMed 28049271Asakura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia-Zhen Li, MS study director
Asia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constipation Health Education Intervention Course and General Health Course in people with Constipation, run by Asia University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of parents' knowledge towards constipation related issues between 0-week and 4-week (time frame: 0-week, 4-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590846, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.