School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong

Obesity Clinical Trial

Official title:

School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463069
• Other study ID #: 30160054
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2022
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability
• Obesity

Intervention

Other:
• Adapted physical activity
This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.

Locations

Country	Name	City	State
China	Hong Kong Bapist University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI Change	The primary outcome variable was change in BMI (weight (kg) / height2 (m)) that was further calculated from the height and weight measured at school in the morning time. Height was measured to the nearest 0.1 cm using a stadiometer and weight was measured to the nearest 0.1 kg on a TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.	Change from baseline at 4 months and 9 months
Secondary	BMIz Change	The BMIz was converted from the BMI values using WHO 2007 reference standards. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values denote a higher BMI.	Change from baseline at 4 months and 9 months
Secondary	Weight Change	Weight was measured to the nearest 0.1 kg on a calibrated TANITA digital scale (TBF-410) with the subject wearing lightweight clothing and no shoes.	Change from baseline at 4 months and 9 months
Secondary	Percent Body Fat Change	Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.	Change from baseline at 4 months and 9 months
Secondary	Waist Circumference Change	Waist circumference (cm) was measured with a flexible meter ribbon accurate to 0.1 cm at the midway between the lowest rib margin and the top of the iliac crest at the end of gentle expiration	Change from baseline at 4 months and 9 months
Secondary	Waist-to-height Ratio Change	Waist-to-height ratio was calculated by dividing the waist circumference by the height.	Change from baseline at 4 months and 9 months
Secondary	Cardiorespiratory Fitness Change	Cardiorespiratory fitness was assessed using the 9-minute run/walk test. The test measured how far a person can cover a flat surface 25 meters in length over a 9-minute period.	Change from baseline at 4 months and 9 months
Secondary	Muscular Strength and Endurance Change	The muscular strength and endurance were measured by handgrip strength and sit-ups. The handgrip strength was measured using a dynamometer (Takei, TKK5001, GRIP-A digital dynamometer). The sit-ups measured the total number of correctly completed sit-ups performed in 30 seconds.	Change from baseline at 4 months and 9 months
Secondary	Flexibility Change	Flexibility was measured by the sit-and-reach test.	Change from baseline at 4 months and 9 months