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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 2, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedDecember 4, 2018
December 1, 2018
1.5 years
July 2, 2017
December 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from flow-mediated dilation (FMD) at 6 weeks
for brachial endothelial function assessment
before and after the 6-week intervention
Secondary Outcomes (4)
Change from circulating exosome-derived miRNAs at 6 weeks
before and after the 6-week intervention
Change from circulating irisin levels at 6 weeks
before and after the 6-week intervention
Change from pulse wave velocity at 6 weeks
before and after the 6-week intervention
Change from heart rate variability at 6 weeks
before and after the 6-week intervention
Other Outcomes (2)
Change from the composition of gut microbiota at 6 weeks
before and after the 6-week intervention
Change from short chain fatty acids (SCFAs) concentractions at 6 weeks
before and after the 6-week intervention
Study Arms (2)
Obese intervention group
EXPERIMENTALObese children were received exercise and diet intervention for 6 weeks.
Normal weight control group
NO INTERVENTIONNormal weight children were recruited as a control group without any intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants aged 7-17 years
- 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
You may not qualify if:
- Metabolic disease
- Gastrointestinal disease
- Cardiac disease
- Taking medications which affected energy expenditure
- Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Sport University
Guangzhou, Guangdong, 510000, China
Related Publications (2)
Huang J, Liao J, Fang Y, Deng H, Yin H, Shen B, Hu M. Six-Week Exercise Training With Dietary Restriction Improves Central Hemodynamics Associated With Altered Gut Microbiota in Adolescents With Obesity. Front Endocrinol (Lausanne). 2020 Dec 7;11:569085. doi: 10.3389/fendo.2020.569085. eCollection 2020.
PMID: 33365012DERIVEDLiao J, Huang J, Wang S, Xiang M, Wang D, Deng H, Yin H, Xu F, Hu M. Effects of exercise and diet intervention on appetite-regulating hormones associated with miRNAs in obese children. Eat Weight Disord. 2021 Mar;26(2):457-465. doi: 10.1007/s40519-020-00869-9. Epub 2020 Feb 18.
PMID: 32072570DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Hu, PhD
Guangzhou Sport University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion
Study Record Dates
First Submitted
July 2, 2017
First Posted
December 4, 2018
Study Start
July 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
December 4, 2018
Record last verified: 2018-12