Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability

NCT ID: NCT04554355

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-06-30

Brief Summary

The proposed study will be a 12-week school-based physical activity (PA) program with a 2-armed randomized controlled trial (RCT) design. It will target overweight and obese children with intellectual disability (ID). The primary outcomes will be both fatness-related and fitness-related outcomes. In addition, the effect of the intervention on blood pressure will be evaluated as the secondary outcomes.

Detailed Description

Childhood obesity and lower HRPF levels are major threats to public health. The previous research finds that children with ID are more vulnerable to be obesity and lower HRPF levels than general pediatric population. In addition, the transition from adolescence to young adulthood is recognized as a particularly high-risk period for weight gain. However, Interventions to reduce obesity and improve HRPF levels among adolescents with ID are scarce. The main purpose of this study is to implement and evaluate a fun game-based PA program to reduce overweight/obesity and improve health-related physical fitness (HRPF) levels among adolescents with ID (aged 12-18 years old).

The study consists of a 3-month intervention and a 3-month follow-up. Totally Forty-eight overweight/obese adolescents with mild intellectual disability (ID) will be recruited from special schools in China and then randomly assigned into two groups (n=24 for each group). Selection criteria for participants are: (1) children with mild ID; (2) aged 12-18 years old; (3) being overweight or obese; (4) without physical disability and other relevant health conditions. Participants in the experimental group will receive a fun game-based PA program (60 min/time, 2 sessions/week, 24 sessions totally) at school. No intervention will be provided to participants in the control group.

All participants in the two groups (N=48) will undertake repeated measurements on a set of study outcomes for three times. All measurements are non-invasive and no potential consequences are expected. In addition, questionnaires will be used to collect each participant's information of socio-demographic characteristics, physical activity level and eating habits (about 15 minutes).

The investigators expect the findings from the study would make up the knowledge gap and help eliminate existing health inequities among children with ID. It would serve as an example for use of other researchers, policy-makers, and the public to tackle off obesity among adolescents with ID in a global scale. If effective, this program would be welcomed and adopted by other special schools in the future. In addition, the effective model can also be extended to reach students with ID in normal schools.

Conditions

Obesity; Health-related Physical Fitness; Intellectual Disability

Keywords

Overweight; Obesity; Fitness; Adolescents; Intellectual disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Participants in this group will receive a three-month PA intervention (60 minutes/session, two sessions/week).

Group Type: EXPERIMENTAL

School-based PA intervention

Intervention Type: BEHAVIORAL

Provide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels.

Control group

No intervention will be provided, participants in this group need to attend the regular school activities as normal.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

School-based PA intervention

Provide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• children with mild ID;
• aged 12-18 years old;
• overweight or obese;
• at least one family member who is able to attend the program with them.

Exclusion Criteria

• with physical disability;
• with a medical predisposition towards obesity (such as genetic syndrome) that could interfere with the results of the study;
• with contraindications for PA (e.g. severe heart disease).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

Gao Yang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Aiwei Wang, Master

Role: STUDY_DIRECTOR

Hong Kong Baptist University

Locations

Hong Kong Bapist University

Hong Kong, , China

Countries

China

References

Wang A, Bu D, Yu S, Sun Y, Wang J, Lee TCT, Baker JS, Gao Y. Effects of a School-Based Physical Activity Intervention for Obesity, Health-Related Physical Fitness, and Blood Pressure in Children with Intellectual Disability: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 22;19(19):12015. doi: 10.3390/ijerph191912015.

Reference Type: DERIVED

PMID: 36231316 (View on PubMed)

Wang A, Gao Y, Wang J, Tong TK, Sun Y, Yu S, Zhao H, Zou D, Zhang Z, Qi Y, Zuo N, Bu D, Zhang D, Xie Y, Baker JS. Effects of a School-Based Physical Activity Intervention for Obesity and Health-Related Physical Fitness in Adolescents With Intellectual Disability: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 22;10(3):e25838. doi: 10.2196/25838.

Reference Type: DERIVED

PMID: 33749611 (View on PubMed)

Other Identifiers

PHDSPE17482062

Identifier Type: -

Identifier Source: org_study_id