Clinical trial NCT04463069: School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Official title: School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: adolescents
intellectual disability
overweight
obesity
physical activity
intervention
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering that children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to develop and evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID. The hypothesis of the study was the APA program would be able to decrease obesity among adolescents with ID.

Detailed description: Background: Children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID.

Methods: A 9-month randomized controlled trial of a school-based APA program was conducted in adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the APA program which consisted of endurance and strength-building exercises at a frequency of two sessions per week, while the control group received routine PE classes as usual. Data on obesity-related variables were collected before the intervention, at the midpoint of the intervention and after the intervention. Linear mixed-effect models were used to examine the intervention effects.

Eligibility criteria: Inclusion Criteria:

* aged between 12 and 18 years
* overweight and obesity
* mild or moderate intellectual disability

Exclusion Criteria:

* physical disability
* medical predispositions towards obesity (genetic syndrome or drug treatment)
* contraindications (e.g. asthma, heart disease)
* having participated in other exercise programs in the past 6 months.

Primary outcomes:
measure: BMI Change
timeFrame: Change from baseline at 4 months and 9 months
Secondary outcomes:
measure: BMIz Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Weight Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Percent Body Fat Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Waist Circumference Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Waist-to-height Ratio Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Cardiorespiratory Fitness Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Muscular Strength and Endurance Change
timeFrame: Change from baseline at 4 months and 9 months
measure: Flexibility Change
timeFrame: Change from baseline at 4 months and 9 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
References: