A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

NCT02773823 | Completed

• 1 other identifier: 81372973
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

obesity; children; cardiovascular health; intervention study

Outcome Measures

Primary Outcomes (7)

• Body weight of study children

  Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.

  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).

  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.

  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.

  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.

  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.

  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.

  8 months

Secondary Outcomes (2)

• Well-being of study children

  8 months

• Depression of study children

  8 months

Study Arms (2)

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.

Behavioral: Intervention group

Control

NO INTERVENTION

No intervention in the group with "control".

Interventions

Intervention group BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Obese children; Aged 8-12 years old.

You may not qualify if:

• History of cardiovascular diseases and diabetes; Disability.

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Wuhan university

Wuhan, Hubei, 430071, China

Location

Related Publications (5)

• 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.

  PMID: 11556298 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 21108961 BACKGROUND

• 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.

  PMID: 21883107 BACKGROUND

• 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.

  PMID: 20368384 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiqiang He, PhD

  Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: May 16, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

CN (1)