A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

NCT ID: NCT02773823

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type ACTIVE_COMPARATOR

Intervention group

Intervention Type BEHAVIORAL

Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.

Control

No intervention in the group with "control".

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention group

Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Obese children; Aged 8-12 years old.

Exclusion Criteria

* History of cardiovascular diseases and diabetes; Disability.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wuhan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Qiqiang He

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qiqiang He, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wuhan university

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11556298 (View on PubMed)

Knowler 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.

Reference Type BACKGROUND
PMID: 11832527 (View on PubMed)

He 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.

Reference Type BACKGROUND
PMID: 21108961 (View on PubMed)

Semba 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.

Reference Type BACKGROUND
PMID: 21883107 (View on PubMed)

Thompson 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.

Reference Type BACKGROUND
PMID: 20368384 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81372973

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Obesity Prevention in School-aged Children
NCT07203300 NOT_YET_RECRUITING NA