Skip to content

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

Effects of Exercise Training and Diet Restriction on Cardiovascular Function and Their Related Factors in Obese Chinese Children and Adolescents: an Intervention Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03762629
Enrollment
90
Registered
2018-12-04
Start date
2017-07-01
Completion date
2018-12-31
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Obesity, Childhood Obesity

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALExercise

Subjects were provided with energy-restricted diets of 1300-2200 kcal/day based on weight. The energy percentages provided by protein, fat and carbohydrate were 20%, 20% and 60%, respectively, while energy distributions at breakfast, lunch and dinner were 30%, 40% and 30%, respectively. Subjects performed a series of endurance exercise such as bicycling, walking, running, dancing and ball games for 5 hour/day, supplemented with resistance exercise. Training interventions were performed 5-6 day/week for 6 weeks. The exercise program was designed to result in an energy expenditure of 1500-2500 kcal/day.

Sponsors

Guangzhou Sport University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from flow-mediated dilation (FMD) at 6 weeksbefore and after the 6-week interventionfor brachial endothelial function assessment

Secondary

MeasureTime frameDescription
Change from circulating exosome-derived miRNAs at 6 weeksbefore and after the 6-week interventionexosome-secreted miRNA levels in plasma
Change from circulating irisin levels at 6 weeksbefore and after the 6-week interventionirisin concentration in plasma
Change from pulse wave velocity at 6 weeksbefore and after the 6-week interventionfor arterial stiffness assessment
Change from heart rate variability at 6 weeksbefore and after the 6-week interventionfor cardiac autonomic function assessment

Other

MeasureTime frameDescription
Change from the composition of gut microbiota at 6 weeksbefore and after the 6-week interventionthe composition of gut microbiota in fecal samples
Change from short chain fatty acids (SCFAs) concentractions at 6 weeksbefore and after the 6-week interventionshort chain fatty acids (SCFAs) concentractions in fecal samples

Countries

China

Contacts

Primary ContactJunhao Huang, PhD
junhaohuang2006@hotmail.com+86 (0)20 3802 5087
Backup ContactDan Wang
17880383@qq.com+86 (0)20 3802 5087

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026