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

• Sponsor: Hong Kong Baptist University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04463069
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 8.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Adapted physical activity	N/A

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
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. BMI Change [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 Outcome Measures

1. BMIz Change [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 [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 [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 [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 [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 [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 [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 [Change from baseline at 4 months and 9 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong Kong Bapist University	Hong Kong		China

Sponsors and Collaborators

• Hong Kong Baptist University

Investigators

• Principal Investigator: Yang Gao, PhD, Hong Kong Baptist University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2018
• Informed Consent Form - Apr 4, 2018

More Information

Publications

None provided.

• Responsible Party: Gao Yang, Assistant Professor, Hong Kong Baptist University
• ClinicalTrials.gov Identifier: NCT04463069
• Other Study ID Numbers: 30160054
• First Posted: Jul 9, 2020
• Last Update Posted: May 9, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gao Yang, Assistant Professor, Hong Kong Baptist University: adolescents; intellectual disability; overweight; obesity; physical activity; intervention
• Additional relevant MeSH terms: Intellectual Disability; Obesity

Study Results

Participant Flow

Recruitment Details

Initially, 81 eligible students with parental informed consent were recruited (41 in intervention and 40 in control). 13 in control withdrew after learning the assignment results. 5 more were then recruited into the control to fulfill sample size (32). After commencement of study, 2 and 10 withdrew from intervention and control respectively. Finally, 61 (39 in intervention and 22 in control) completed the study.

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Period Title: Overall Study
STARTED	41	45
COMPLETED	39	22
NOT COMPLETED	2	23

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.	Total of all reporting groups
Overall Participants	39	22	61
Age (Count of Participants)
<=18 years	39 100%	22 100%	61 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	8 20.5%	8 36.4%	16 26.2%
Male	31 79.5%	14 63.6%	45 73.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
China	39 100%	22 100%	61 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4 months	-0.14	0.42
Mean change from baseline to 9 months	-0.66	0.68

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4	-0.06	0.07
Mean change from baseline to 9	-0.23	0.10

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4	0.42	1.79
Mean change from baseline to 9	-0.15	2.76

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4	-0.19	0.80
Mean change from baseline to 9	-1.46	0.24

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4	-1.66	1.50
Mean change from baseline to 9	-2.02	1.76

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group 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. 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.	Participants in the control group received no intervention in the study time period.
Measure Participants	39	22
Mean change from baseline to 4	-0.01	0.01
Mean change from baseline to 9	-0.02	0.01

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Flexibility Change
Description	Flexibility was measured by the sit-and-reach test.
Time Frame	Change from baseline at 4 months and 9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	9 months
Adverse Event Reporting Description	Possible adverse effects (e.g., sports injury, underweight, binge eating) suggested by previous studies will be prevented via diverse means (e.g., to inform children and parents of the possible adverse consequences in advance and provide feasible and practical preventive strategies to them). They can reach the research team via a hotline on an ad hoc basis. The adverse events will be monitored among participants who completed the baseline assessments.
Arm/Group Title	Intervention Group		Control Group
Arm/Group 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. 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.		Participants in the control group received no intervention in the study time period.
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.