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

NCT ID: NCT03762629

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-12-31

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.

Conditions

Childhood Obesity; Adolescent Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Obese intervention group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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.

Normal weight control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

diet restriction

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Sport University

OTHER

Sponsor Role: lead

Responsible Party

Min Hu

Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Sport University

Locations

Guangzhou Sport University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junhao Huang, PhD

Role: CONTACT

junhaohuang2006@hotmail.com

+86 (0)20 3802 5087

Dan Wang

Role: CONTACT

17880383@qq.com

+86 (0)20 3802 5087

Facility Contacts

Junhao Huang, PhD

Role: primary

junhaohuang2006@hotmail.com

+86 (0)20 3802 5087

References

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.

Reference Type: DERIVED

PMID: 33365012 (View on PubMed)

Liao 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.

Reference Type: DERIVED

PMID: 32072570 (View on PubMed)

Other Identifiers

Trial2017.1

Identifier Type: -

Identifier Source: org_study_id