- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463069
School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, China
- Hong Kong Bapist University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
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.
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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.
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No Intervention: control group
Participants in the control group received no intervention in the study time period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI Change
Time Frame: Change from baseline at 4 months and 9 months
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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.
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Change from baseline at 4 months and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMIz Change
Time Frame: Change from baseline at 4 months and 9 months
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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.
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Change from baseline at 4 months and 9 months
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Weight Change
Time Frame: Change from baseline at 4 months and 9 months
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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.
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Change from baseline at 4 months and 9 months
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Percent Body Fat Change
Time Frame: Change from baseline at 4 months and 9 months
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Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.
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Change from baseline at 4 months and 9 months
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Waist Circumference Change
Time Frame: Change from baseline at 4 months and 9 months
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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
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Change from baseline at 4 months and 9 months
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Waist-to-height Ratio Change
Time Frame: Change from baseline at 4 months and 9 months
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Waist-to-height ratio was calculated by dividing the waist circumference by the height.
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Change from baseline at 4 months and 9 months
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Cardiorespiratory Fitness Change
Time Frame: Change from baseline at 4 months and 9 months
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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.
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Change from baseline at 4 months and 9 months
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Muscular Strength and Endurance Change
Time Frame: Change from baseline at 4 months and 9 months
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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.
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Change from baseline at 4 months and 9 months
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Flexibility Change
Time Frame: Change from baseline at 4 months and 9 months
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Flexibility was measured by the sit-and-reach test.
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Change from baseline at 4 months and 9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yang Gao, PhD, Hong Kong Baptist University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30160054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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