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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Adapted physical activity
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring adolescents, intellectual disability, overweight, obesity, physical activity, intervention

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hong Kong Bapist University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.

Participants in the control group received no intervention in the study time period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percent Body Fat Change
Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.
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
Waist-to-height Ratio Change
Waist-to-height ratio was calculated by dividing the waist circumference by the height.
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.
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.
Flexibility Change
Flexibility was measured by the sit-and-reach test.

Full Information

First Posted
June 28, 2020
Last Updated
April 12, 2022
Sponsor
Hong Kong Baptist University
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1. Study Identification

Unique Protocol Identification Number
NCT04463069
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
adolescents, intellectual disability, overweight, obesity, physical activity, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group participated in the APA intervention consisting of simple and fun endurance and strength-building exercise at a frequency of two sessions per week.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants in the control group received no intervention in the study time period.
Intervention Type
Other
Intervention Name(s)
Adapted physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI Change
Description
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.
Time Frame
Change from baseline at 4 months and 9 months
Secondary Outcome Measure Information:
Title
BMIz Change
Description
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.
Time Frame
Change from baseline at 4 months and 9 months
Title
Weight Change
Description
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.
Time Frame
Change from baseline at 4 months and 9 months
Title
Percent Body Fat Change
Description
Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.
Time Frame
Change from baseline at 4 months and 9 months
Title
Waist Circumference Change
Description
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
Time Frame
Change from baseline at 4 months and 9 months
Title
Waist-to-height Ratio Change
Description
Waist-to-height ratio was calculated by dividing the waist circumference by the height.
Time Frame
Change from baseline at 4 months and 9 months
Title
Cardiorespiratory Fitness Change
Description
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.
Time Frame
Change from baseline at 4 months and 9 months
Title
Muscular Strength and Endurance Change
Description
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.
Time Frame
Change from baseline at 4 months and 9 months
Title
Flexibility Change
Description
Flexibility was measured by the sit-and-reach test.
Time Frame
Change from baseline at 4 months and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Gao, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Bapist University
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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