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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04463069

Enrollment

Registered

2020-07-09

Start date

2018-09-01

Completion date

2019-06-30

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

adolescents, intellectual disability, overweight, obesity, physical activity, intervention

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.

Interventions

OTHERAdapted 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

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.

Participants by arm

Arm	Count
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. 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.	39
Control Group Participants in the control group received no intervention in the study time period.	22
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Participants' parents refused to participate after learning the assignment results	0	13
Overall Study	Withdrawal by Subject	2	10

Baseline characteristics

Characteristic	Control Group	Total	Intervention Group
Age, Categorical <=18 years	22 Participants	61 Participants	39 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment China	22 participants	61 participants	39 participants
Sex: Female, Male Female	8 Participants	16 Participants	8 Participants
Sex: Female, Male Male	14 Participants	45 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 41	0 / 29
other Total, other adverse events	0 / 41	0 / 29
serious Total, serious adverse events	0 / 41	0 / 29

Outcome results

Primary

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.