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

H

Hong Kong Baptist University

Status

Completed

Conditions

Health-related Physical Fitness
Obesity
Intellectual Disability

Treatments

Behavioral: School-based PA intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04554355
PHDSPE17482062

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

86 participants in 2 patient groups

Intervention group
Experimental group
Description:
Participants in this group will receive a three-month PA intervention (60 minutes/session, two sessions/week).
Treatment:
Behavioral: School-based PA intervention
Control group
No Intervention group
Description:
No intervention will be provided, participants in this group need to attend the regular school activities as normal.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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