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Completed

NCT Number: NCT04463069

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Intellectual Disability Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Bapist University

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

adapted physical activity

Other

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 outcomes

  1. 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

  1. BMIz Change

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

    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.

  2. Weight Change

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

    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.

  3. Percent Body Fat Change

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

    Percent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.

  4. Waist Circumference Change

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

    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

  5. Waist-to-height Ratio Change

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

    Waist-to-height ratio was calculated by dividing the waist circumference by the height.

  6. Cardiorespiratory Fitness Change

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

    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.

  7. Muscular Strength and Endurance Change

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

    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.

  8. Flexibility Change

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

    Flexibility was measured by the sit-and-reach test.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2020
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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