Cardiovascular DiseasesNCT02773823
A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren
A study testing Intervention group in people with Cardiovascular Diseases, run by Wuhan University at 1 site in China.
Trial summary
The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. The intervention methods include dietary instruction and exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids and glucose. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jun 2017
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obese children; Aged 8-12 years old.
Who cannot join
- History of cardiovascular diseases and diabetes; Disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors
The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. The intervention methods include dietary instruction and exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids and glucose.
Read the detailed description
Two public primary schools of a similar size were selected. They were allocated either to the intervention or control group. Children in Grade 4th and 5th in each school were invited to participate in the physical examination (height and weight measures).Obese children based on Chinese BMI cut-off points were included in this study.Children in the intervention group were encouraged to take healthy diet habits and increased their physical activity.After eight months healthy behavior intervention, Children's height, weight, waist, hip, blood pressure, cardiorespiratory fitness will be measured. Fasting blood will be taken to measure lipids and glucose levels.
- Conditions
- Cardiovascular Diseases
- Being tested
- Intervention group
- Keywords
- obesity, children, cardiovascular health, intervention study
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Lifestyle intervention includes diet instruction and exercise intervention:
1. Diet instruction: The children were asked to increase fruit/vegetables consumption, reduce high fat food, etc.
2. Exercise intervention: The children participated sports 60 min/day,5d/week for 8 months. Receives: Behavioral: Intervention group |
| Control | No intervention | No intervention in the group with "control". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight of study children
Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.
Measured: 8 months
Body mass index of study children
Body mass index is defined as the individual's body weight divided by the square of his or her height (height is measured using a non- stretchable tape suspended from the wall is recorded to the nearest 0.1 cm).
Measured: 8 months
Waist circumference of study children
Waist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm.
Measured: 8 months
Blood pressure
Blood pressure will be measured three times by auscultation method with appropriate cuff size after 20 minutes of rest.The average of the blood pressure measurements is defined as hypertension if it was >95th percentile according to their age, gender and height percentile.
Measured: 8 months
Blood lipids
Blood samples will be obtained in the morning by venipuncture after an overnight fast. Serum lipid profiles (total cholesterol ,triglycerides, low-density lipoprotein, high-density lipoprotein) will be measured using routine enzymatic methods.
Measured: 8 months
Blood glucose
Blood samples is obtained in the morning by venipuncture after an overnight fast. The glucose oxidase method was used in the determination of blood glucose levels.
Measured: 8 months
cardiorespiratory fitness of study children
Cardiorespiratory refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity. It is measured by 20 meter shuttle-run test.
Measured: 8 months
Secondary outcomes (2)
Well-being of study children
Well-being will be measured by The WHO 5-item Well-Being Index (WHO-5), which is a short screening instrument for the detection of depression in the general population,
Measured: 8 months
Depression of study children
The Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiqiang He, Wuhan University
- Investigators
- Qiqiang He, PhD, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773823
- Sponsor's protocol ID
- 81372973
- Status last verified
- Oct 2018
- First submitted
- 7 May 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med. 2001 Sep 13;345(11):790-7. doi: 10.1056/NEJMoa010492.
PubMed 11556298Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527He QQ, Wong TW, Du L, Jiang ZQ, Yu TS, Qiu H, Gao Y, Liu WJ, Wu JG. Physical activity, cardiorespiratory fitness, and obesity among Chinese children. Prev Med. 2011 Feb;52(2):109-13. doi: 10.1016/j.ypmed.2010.11.005. Epub 2010 Nov 23.
PubMed 21108961Semba RD, Cappola AR, Sun K, Bandinelli S, Dalal M, Crasto C, Guralnik JM, Ferrucci L. Plasma klotho and cardiovascular disease in adults. J Am Geriatr Soc. 2011 Sep;59(9):1596-601. doi: 10.1111/j.1532-5415.2011.03558.x. Epub 2011 Aug 24.
PubMed 21883107Thompson D, Markovitch D, Betts JA, Mazzatti D, Turner J, Tyrrell RM. Time course of changes in inflammatory markers during a 6-mo exercise intervention in sedentary middle-aged men: a randomized-controlled trial. J Appl Physiol (1985). 2010 Apr;108(4):769-79. doi: 10.1152/japplphysiol.00822.2009.
PubMed 20368384
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02773823
- Acronym / sponsor ID
- 81372973
- Conditions
- Cardiovascular Diseases
- Keywords
- obesity, children, cardiovascular health, intervention study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- 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 evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. The intervention methods include dietary instruction and exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids and glucose.
Detailed description
Two public primary schools of a similar size were selected. They were allocated either to the intervention or control group. Children in Grade 4th and 5th in each school were invited to participate in the physical examination (height and weight measures).Obese children based on Chinese BMI cut-off points were included in this study.Children in the intervention group were encouraged to take healthy diet habits and increased their physical activity.After eight months healthy behavior intervention, Children's height, weight, waist, hip, blood pressure, cardiorespiratory fitness will be measured. Fasting blood will be taken to measure lipids and glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Intervention groupLifestyle intervention includes diet instruction and exercise intervention: 1. Diet instruction: The children were asked to increase fruit/vegetables consumption, reduce high fat food, etc. 2. Exercise intervention: The children participated sports 60 min/day,5d/week for 8 months. |
| Control | No intervention | –No intervention in the group with "control". |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Obese children; Aged 8-12 years old.
Key exclusion criteria (1 listed)
- History of cardiovascular diseases and diabetes; Disability.
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 |
|---|---|---|
| Intervention groupDiet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months. | Behavioural | Intervention |
Primary outcome
Body weight of study children
Time frame: 8 months
Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.
Body mass index of study children
Time frame: 8 months
Body mass index is defined as the individual's body weight divided by the square of his or her height (height is measured using a non- stretchable tape suspended from the wall is recorded to the nearest 0.1 cm).
Waist circumference of study children
Time frame: 8 months
Waist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm.
Blood pressure
Time frame: 8 months
Blood pressure will be measured three times by auscultation method with appropriate cuff size after 20 minutes of rest.The average of the blood pressure measurements is defined as hypertension if it was >95th percentile according to their age, gender and height percentile.
Blood lipids
Time frame: 8 months
Blood samples will be obtained in the morning by venipuncture after an overnight fast. Serum lipid profiles (total cholesterol ,triglycerides, low-density lipoprotein, high-density lipoprotein) will be measured using routine enzymatic methods.
Blood glucose
Time frame: 8 months
Blood samples is obtained in the morning by venipuncture after an overnight fast. The glucose oxidase method was used in the determination of blood glucose levels.
cardiorespiratory fitness of study children
Time frame: 8 months
Cardiorespiratory refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity. It is measured by 20 meter shuttle-run test.
2 secondary outcomes
Well-being of study children
Time frame: 8 months
Depression of study children
Time frame: 8 months
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 3 Oct 2018.
- Background: PubMed 11556298Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med. 2001 Sep 13;345(11):790-7. doi: 10.1056/NEJMoa010492.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 21108961He QQ, Wong TW, Du L, Jiang ZQ, Yu TS, Qiu H, Gao Y, Liu WJ, Wu JG. Physical activity, cardiorespiratory fitness, and obesity among Chinese children. Prev Med. 2011 Feb;52(2):109-13. doi: 10.1016/j.ypmed.2010.11.005. Epub 2010 Nov 23.
- Background: PubMed 21883107Semba RD, Cappola AR, Sun K, Bandinelli S, Dalal M, Crasto C, Guralnik JM, Ferrucci L. Plasma klotho and cardiovascular disease in adults. J Am Geriatr Soc. 2011 Sep;59(9):1596-601. doi: 10.1111/j.1532-5415.2011.03558.x. Epub 2011 Aug 24.
- Background: PubMed 20368384Thompson D, Markovitch D, Betts JA, Mazzatti D, Turner J, Tyrrell RM. Time course of changes in inflammatory markers during a 6-mo exercise intervention in sedentary middle-aged men: a randomized-controlled trial. J Appl Physiol (1985). 2010 Apr;108(4):769-79. doi: 10.1152/japplphysiol.00822.2009.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Qiqiang He, PhD principal investigator
Wuhan 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 Intervention group in people with Cardiovascular Diseases, run by Wuhan University 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 1 inclusion and 1 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 3 Oct 2018. 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?
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?
Body weight of study children (time frame: 8 months). The study lists 7 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 NCT02773823, which also lists 5 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 3 Oct 2018.