Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents

Guangzhou Sport University

Status: Unknown

Conditions: Childhood Obesity; Adolescent Obesity

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03762629

Trial2017.1

Details and patient eligibility

About

Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may already be associated with serious comorbidities, obese adolescents are at significantly higher risk for obesity and increased morbidity and mortality during adulthood. Combined lifestyle interventions, which include regular physical activity and dietary restriction, have been shown to result in most significant improvements in cardiovascular function and their associated factors in the pediatric and adolescent population with obesity. The aim of this study is to investigate the effects of a combined exercise and diet intervention on cardiovascular function and their associated factors in obese children.

Full description

Sixty obese children and adolescents will complete a 6-week program of exercise and diet intervention. Thirty normal-weight children and adolescents will be recruited as control group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin levels of the subjects will be measured before and after 6-week intervention. Endothelial function will be assessed by a flow-mediated dilation test. Circulating exosome-derived miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin concentration in plasma and arterial stiffness as well as cardiac autonomic function will be investigated before and after the 6-week intervention. Fecal samples were collected before and after the 6-week intervention for analysis of the compositional and functional changes in the human gut microbiota.

Enrollment: 90 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants aged 7-17 years
2. Participants satisfied the obesity diagnosis criteria is based on "Body mass index reference standards for the screening of overweight and obesity in Chinese children and adolescents" released in 2004, with cut-off points of p(95) for obesity

Exclusion criteria

1. Metabolic disease
2. Gastrointestinal disease
3. Cardiac disease
4. Taking medications which affected energy expenditure
5. Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Obese intervention group

Experimental group

Description:

Obese children were received exercise and diet intervention for 6 weeks.

Treatment:

Behavioral: Exercise

Normal weight control group

No Intervention group

Description:

Normal weight children were recruited as a control group without any intervention.