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Clinical Trials/NCT04463069
NCT04463069CompletedNot Applicable

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

Hong Kong Baptist University1 site in 1 country86 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
BMI Change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

BMI Change

Time Frame: Change from baseline at 4 months and 9 months

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 Outcomes

  • Weight Change(Change from baseline at 4 months and 9 months)
  • BMIz Change(Change from baseline at 4 months and 9 months)
  • Percent Body Fat Change(Change from baseline at 4 months and 9 months)
  • Waist Circumference Change(Change from baseline at 4 months and 9 months)
  • Waist-to-height Ratio Change(Change from baseline at 4 months and 9 months)
  • Muscular Strength and Endurance Change(Change from baseline at 4 months and 9 months)
  • Flexibility Change(Change from baseline at 4 months and 9 months)
  • Cardiorespiratory Fitness Change(Change from baseline at 4 months and 9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gao Yang

Assistant Professor

Hong Kong Baptist University

Study Sites (1)

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