Prevention and Intervention of Overweight and Obesity in Preschool Children

NCT06562465 | Recruiting

• 1 other identifier: OABIPC
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

Brief Summary

Obesity is an important public health problem, which is directly related to the risk of childhood complications and the increase of incidence rate and mortality of adult complications. The consequences are more serious than malnutrition such as low weight. Since the 1980s, the obesity rate among children in China has gradually increased. Currently, overweight and obesity are important health issues for children in rural and urban areas of China, with obesity rates in many large cities approaching or exceeding those in developed countries. The Report on Nutrition and Chronic Disease Status of Chinese Residents (2020) shows that the overweight and obesity rate among children aged 6-17 in China has approached 20%, with 10% of children under 6 years old. The imbalance between energy intake and expenditure is the direct cause of individual overweight and obesity. The 2021 "Healthy Children Action Plan (2021-2025)" explicitly requires the implementation of early screening, early diagnosis, and early treatment prevention and control strategies for risk factors such as obesity that seriously endanger children's health, reducing disease burden, promoting children's health, emphasizing the principle of prevention first and combining prevention and treatment. Given the current status of children's nutrition and health in China, it is an urgent need to establish a standardized and regulated monitoring and management system for obesity and overweight in preschool children, as well as service standards, for the development of children's health. This project aims to establish a complete prevention, improvement, and intervention promotion plan for obesity and overweight in preschool children, as well as a comprehensive monitoring and management system that combines medicine, education, home, and community. It will strengthen children's nutrition feeding and exercise guidance, reduce sedentary time, promote food and movement balance, and prevent and reduce childhood overweight and obesity. Provide children with comprehensive, full process, and warm children's healthcare clothing, and provide small-scale policy research references for the implementation of support systems for children's nutrition improvement projects.

Conditions

Overweight and Obesity

Keywords

Diet management; sports management; overweight; obesity; preschool children

Outcome Measures

Primary Outcomes (1)

• BMI

  Changes in BMI between the experimental group and intervention group at the beginning and end of the project

  3-4 months

Secondary Outcomes (3)

• Body composition--Fat (%)

  3-4 months

• Body composition--Body fat index (BFMI)

  3-4 months

• Body composition--Fat-free mass index (FFMI)

  3-4 months

Other Outcomes (14)

• questionnaire investigation

  3-4 months

• Blood indicators--ALT

  3-4 months

• Blood indicators--AST

  3-4 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The overweight and obese children aged 3-6 years old,receive dietary and exercise management, combined reward support mechanisms.

Procedure: dietary and exercise management

Control group

ACTIVE COMPARATOR

The overweight and obese children aged 3-6 years old only receive basic health guidance,do not receive dietary and exercise management nor combined reward support mechanisms like experimental group.

Procedure: no dietary and exercise management

Interventions

dietary and exercise management PROCEDURE

Dietary and exercise management: dietary management by providing tailored recipes, health education lectures, science competitions, etc；exercise management:develop weekly and monthly exercise plans for children of different ages, and have physical education teachers lead them in exercising.

Experimental group

no dietary and exercise management PROCEDURE

NO dietary and exercise management:do not implement dietary and exercise management related to the experimental group

Control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• overweight or obese Children Currently, there are no projects related to overweight and obesity management (such as weight loss management, etc.) Parents and children are willing to accept dietary and exercise management for a period of 4 months Willing to measure height, weight, BMI, blood pressure, body composition, questionnaire survey (exercise, diet, etc.) and other items before intervention and 1 month, 2 months, 3 months, and 4 months after intervention (a total of 5 times) Willing to undergo blood tests before and 4 months after intervention (2 times in total); The questionnaire information is filled in accurately and meets the questionnaire quality control standards

You may not qualify if:

• Preschool children with underlying diseases (such as congenital heart disease, liver and kidney disease, thyroid disease, malignant tumors, etc.) or uncontrolled underlying diseases
• Incorrect information filling in the questionnaire, which does not meet the questionnaire quality control standards

Sponsors & Collaborators

• Chen Li: lead
• Children's Hospital of Chongqing Medical University: collaborator
• China Soong Ching Ling Foundation: collaborator

Study Sites (2)

Growth,Development and Mental Health of Children and Adolescents Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Children's Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (4)

• Dong YH, Chen L, Liu JY, Ma T, Zhang Y, Chen MM, Zhong PL, Shi D, Hu PJ, Li J, Dong B, Song Y, Ma J. [Epidemiology and prediction of overweight and obesity among children and adolescents aged 7-18 years in China from 1985 to 2019]. Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Feb 28;57:11-19. doi: 10.3760/cma.j.cn112150-20220906-00881. Online ahead of print. Chinese.

  PMID: 36854438 BACKGROUND

• Lister NB, Baur LA, Felix JF, Hill AJ, Marcus C, Reinehr T, Summerbell C, Wabitsch M. Child and adolescent obesity. Nat Rev Dis Primers. 2023 May 18;9(1):24. doi: 10.1038/s41572-023-00435-4.

  PMID: 37202378 BACKGROUND

• Hughes AR, Sherriff A, Ness AR, Reilly JJ. Timing of adiposity rebound and adiposity in adolescence. Pediatrics. 2014 Nov;134(5):e1354-61. doi: 10.1542/peds.2014-1908. Epub 2014 Oct 13.

  PMID: 25311600 RESULT

• Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.

  PMID: 31332776 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director

Model Details: Recruit at least 174 overweight and obese children from kindergartens with a population of 200 or more in Chongqing, and recruit them in the order of screening and informed consent until they are fully recruited. Divided into intervention group and blank control group based on kindergarten.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 20, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)