UrolithiasisNCT04284241
Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation
A study testing Parents'Health-Education Handbook in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
Trial summary
The aim of this study is to estimate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis. This study is designed as an unmatched clusters randomized intervention trial. Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Parents'Health-Education Handbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2017to 31 Oct 2022
- 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 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term newborn (37-42 weeks pregnant) .
- The weight is ≥2.5 kg at birth.
Who cannot join
- Urinary system congenital malformation.
- Sponge kidney.
- Hydronephrosis.
- Ureteropelvic junction obstruction.
- Hypospadias.
- Urinary calculi.
- congenital heart disease.
- Down syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng, Ph.D and M.D, +86 13802916676, gzgyzgh@vip.tom.com
Zanlin Mai
About this study
Official title: Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis in Kashgar Region of China: A Clustered Randomized Controlled Trial
The aim of this study is to estimate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis. This study is designed as an unmatched clusters randomized intervention trial. A total of 171 villages and communities in Shufu Count in Kashgar Region of China are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. Newborns and their parents are assigned to intervention group or control group as their villages or communities. And at least 2314 newborns are needed in this study. Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Newborns' parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire, estimated by scores) related to pediatric stone. Parents in intervention group will undergo and active health education by the investigator with " Parents' Health-Education Handbook", while parents in control group are without the program. Newborns are invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately when they are one, two and three years old. Their parents will be asked to answer the same KAP questionnaire at the same time. The incidence of urolithiasis is evaluated and compared between the two groups. Improvement of knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone of parents are evaluated. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Read the detailed description
Pediatric urolithiasis is a very common disease among Uyghur children of China. Investigators have conducted a cross-sectional survey among children≤14 years in Kashgar Region, which is Uyghur concentrated region and lies in southern Xinjiang Uyghur Autonomous Region July to December 2016. The results showed that the current prevalence rate of urolithiasis was 1.8% among children ≤14 years, while the overall prevalence was 3.6%. The prevalence of urolithiasis for children ≤1 year was 5.63%. Binary logistic regression analysis showed that non-breastfeeding, urinary tract infection, with a family history of urolithiasis and excessive sweating were all statistical significantly associated with increased risk of urinary stone.
Since most of the risks of urolithiasis among Uyghur children are associated with feeding and living habits, investigators create a Parents' Health-Education Handbook based on these results. This Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Investigators use this Handbook to teach newborn's parents to enhance their knowledge of pediatric stone, with a view to change parents' cognition, attitude and behavior of preventing stone formation.
This study is designed as an unmatched clusters randomized intervention trial. The aim of this study is to investigate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis formation. It is conducted in Shufu Count in Kashgar Region of China, which include 171 villages and communities. Investigators define each village or community as a cluster. And these villages and communities are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. A total of 86 villages and communities are assigned to intervention group, while 85 villages and communities are assigned to control group. Participants include newborns and their parents. The newborns and their parents are assigned to intervention group or control group as their villages or communities.
The incidence (same as prevalence) of urolithiasis was 5.63% for children ≤1 year by our former study. The intervention (Parents' Health Education) is considered effective when the incidence decreases more than one half (2.8%) for children when they are 1-year old in this study. So for sample size, we estimate the normal incidence of urolithiasis (π0) is about 5.6% , the incidence will decrease to less than 2.8%(π1) after one year intervention, with α of 0.05, 1-β=90%, 1052 newborns are required by the formula for each group; considered a predicted of 10% missed follow-up late, and at least 2314 newborns needed in this study.
- Conditions
- Urolithiasis
- Being tested
- Parents'Health-Education Handbook
- Keywords
- Pediatric urolithiasis, Uyghur, Parents'Health-Education Handbook
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents'Health-Education HandbookBehavioural
We created a Parents' Health-Education Handbook to teach the newborns' parents to enhance their knowledge of pediatric stone, with a view to changing parents' cognition, attitude and behavior for preventing pediatric stone formation by this cluster randomized control trail.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone. Parents also undergo and active health education by the investigator with the " Parents' Health-Education Handbook", and Handbook will be given to them. Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Follow up is made every year in the first three years, and the program is done as the baseline. Receives: Behavioral: Parents'Health-Education Handbook |
| Control group | No intervention | Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Newborns' parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone. But parents do not undergo active health education. And Handbook will not be given to them. However, a poster which has the same content as the Handbook is normally displayed in the maternity ward. Parents have the opportunity to see the poster, but without any special remind. Follow up is made every year in the first three years, and the program is done as the baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pediatric urolithiasis for the first year.
When kids are one year old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as baseline each time. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Measured: One year after the child was born.
The incidence of pediatric urolithiasis for the second year.
When kids are two years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Measured: Two years after the child was born.
The incidence of pediatric urolithiasis for the third year.
When kids are three years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Measured: Three years after the child was born.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start20 Nov 2017
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohua Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, PhD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284241
- Sponsor's protocol ID
- MRER(72)2017
- Status last verified
- Feb 2020
- First submitted
- 21 Oct 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis in Kashgar Region of China: A Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04284241
- Acronym / sponsor ID
- MRER(72)2017
- Conditions
- Urolithiasis
- Keywords
- Pediatric urolithiasis, Uyghur, Parents'Health-Education Handbook
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Guohua ZengUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 25 Feb 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 aim of this study is to estimate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis. This study is designed as an unmatched clusters randomized intervention trial. A total of 171 villages and communities in Shufu Count in Kashgar Region of China are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. Newborns and their parents are assigned to intervention group or control group as their villages or communities. And at least 2314 newborns are needed in this study. Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Newborns' parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire, estimated by scores) related to pediatric stone. Parents in intervention group will undergo and active health education by the investigator with " Parents' Health-Education Handbook", while parents in control group are without the program. Newborns are invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately when they are one, two and three years old. Their parents will be asked to answer the same KAP questionnaire at the same time. The incidence of urolithiasis is evaluated and compared between the two groups. Improvement of knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone of parents are evaluated. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Detailed description
Pediatric urolithiasis is a very common disease among Uyghur children of China. Investigators have conducted a cross-sectional survey among children≤14 years in Kashgar Region, which is Uyghur concentrated region and lies in southern Xinjiang Uyghur Autonomous Region July to December 2016. The results showed that the current prevalence rate of urolithiasis was 1.8% among children ≤14 years, while the overall prevalence was 3.6%. The prevalence of urolithiasis for children ≤1 year was 5.63%. Binary logistic regression analysis showed that non-breastfeeding, urinary tract infection, with a family history of urolithiasis and excessive sweating were all statistical significantly associated with increased risk of urinary stone.
Since most of the risks of urolithiasis among Uyghur children are associated with feeding and living habits, investigators create a Parents' Health-Education Handbook based on these results. This Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Investigators use this Handbook to teach newborn's parents to enhance their knowledge of pediatric stone, with a view to change parents' cognition, attitude and behavior of preventing stone formation.
This study is designed as an unmatched clusters randomized intervention trial. The aim of this study is to investigate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis formation. It is conducted in Shufu Count in Kashgar Region of China, which include 171 villages and communities. Investigators define each village or community as a cluster. And these villages and communities are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. A total of 86 villages and communities are assigned to intervention group, while 85 villages and communities are assigned to control group. Participants include newborns and their parents. The newborns and their parents are assigned to intervention group or control group as their villages or communities.
The incidence (same as prevalence) of urolithiasis was 5.63% for children ≤1 year by our former study. The intervention (Parents' Health Education) is considered effective when the incidence decreases more than one half (2.8%) for children when they are 1-year old in this study. So for sample size, we estimate the normal incidence of urolithiasis (π0) is about 5.6% , the incidence will decrease to less than 2.8%(π1) after one year intervention, with α of 0.05, 1-β=90%, 1052 newborns are required by the formula for each group; considered a predicted of 10% missed follow-up late, and at least 2314 newborns needed in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Parents'Health-Education HandbookParticipants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone. Parents also undergo and active health education by the investigator with the " Parents' Health-Education Handbook", and Handbook will be given to them. Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Follow up is made every year in the first three years, and the program is done as the baseline. |
| Control group | No intervention | –Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Newborns' parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone. But parents do not undergo active health education. And Handbook will not be given to them. However, a poster which has the same content as the Handbook is normally displayed in the maternity ward. Parents have the opportunity to see the poster, but without any special remind. Follow up is made every year in the first three years, and the program is done as the baseline. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full-term newborn (37-42 weeks pregnant) .
- The weight is ≥2.5 kg at birth.
Key exclusion criteria (8 listed)
- Urinary system congenital malformation.
- Sponge kidney.
- Hydronephrosis.
- Ureteropelvic junction obstruction.
- Hypospadias.
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 |
|---|---|---|
| Parents'Health-Education HandbookWe created a Parents' Health-Education Handbook to teach the newborns' parents to enhance their knowledge of pediatric stone, with a view to changing parents' cognition, attitude and behavior for preventing pediatric stone formation by this cluster randomized control trail. | Behavioural | Intervention group |
Primary outcome
The incidence of pediatric urolithiasis for the first year.
Time frame: One year after the child was born.
When kids are one year old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as baseline each time. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
The incidence of pediatric urolithiasis for the second year.
Time frame: Two years after the child was born.
When kids are two years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
The incidence of pediatric urolithiasis for the third year.
Time frame: Three years after the child was born.
When kids are three years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Guohua Zeng, PhD study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents'Health-Education Handbook in people with Urolithiasis, run by Guohua Zeng at 1 site in China.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng, PhD (+86 13802916676, gzgyzgh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pediatric urolithiasis for the first year. (time frame: One year after the child was born.). 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?
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 25 Feb 2020.