Clinical trial NCT04554355: Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability
Official title: Effects of a School-based Physical Activity Intervention for Fatness and Health-related Physical Fitness in Adolescents With Intellectual Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Health-related Physical Fitness
Intellectual Disability
Keywords: Overweight
Obesity
Fitness
Adolescents
Intellectual disability
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Weight
timeFrame: up to 2 months
measure: Weight
timeFrame: up to 5 months
measure: Weight
timeFrame: up to 8 months
measure: BMI
timeFrame: up to 2 months
measure: BMI
timeFrame: up to 5 months
measure: BMI
timeFrame: up to 8 months
measure: Waist circumference
timeFrame: up to 2 months
measure: Waist circumference
timeFrame: up to 5 months
measure: Waist circumference
timeFrame: up to 8 months
measure: Hip circumference
timeFrame: up to 2 months
measure: Hip circumference
timeFrame: up to 5 months
measure: Hip circumference
timeFrame: up to 8 months
measure: Waist to height ratio
timeFrame: up to 2 months
measure: Waist to height ratio
timeFrame: up to 5 months
measure: Waist to height ratio
timeFrame: up to 8 months
measure: Percent body fat
timeFrame: up to 2 months
measure: Percent body fat
timeFrame: up to 5 months
measure: Percent body fat
timeFrame: up to 8 months
measure: 6-min walk test
timeFrame: up to 2 months
measure: 6-min walk test
timeFrame: up to 5 months
measure: 6-min walk test
timeFrame: up to 8 months
measure: 30-second sit-to-stand
timeFrame: up to 2 months
measure: 30-second sit-to-stand
timeFrame: up to 5 months
measure: 30-second sit-to-stand
timeFrame: up to 8 months
measure: One minute sit-up
timeFrame: up to 2 months
measure: One minute sit-up
timeFrame: up to 5 months
measure: One minute sit-up
timeFrame: up to 8 months
measure: Handgrip strength
timeFrame: up to 2 months
measure: Handgrip strength
timeFrame: up to 5 months
measure: Handgrip strength
timeFrame: up to 8 months
measure: Sit to reach test
timeFrame: up to 2 months
measure: Sit to reach test
timeFrame: up to 5 months
measure: Sit to reach test
timeFrame: up to 8 months
Secondary outcomes:
measure: Blood pressure (both diastolic and systolic blood pressure)
timeFrame: up to 2 months
measure: Blood pressure (both diastolic and systolic blood pressure)
timeFrame: up to 5 months
measure: Blood pressure (both diastolic and systolic blood pressure)
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Bapist University
Study officials:
affiliation: Hong Kong Baptist University
name: Yang Gao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hong Kong Baptist University
name: Aiwei Wang, Master
role: STUDY_DIRECTOR
References:
citation: 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.