NCT04463069

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

Completed NA Results posted Last updated 9 May 2022

What this trial tests

NA trial testing Adapted physical activity in Obesity in 86 participants. Completed in 30 June 2019.

Timeline

1 September 2018

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Hong Kong Baptist University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	86
Start date	1 September 2018
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across China

Drugs / interventions tested

• Adapted physical activity

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Hong Kong Baptist University

Who can join

Adults 12 to 18, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

BMI Change Primary · 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.

Mean change from baseline to 4 months

Group	Value	95% CI
Intervention Group	-0.14	-0.44 – 0.16
Control Group	0.42	0.12 – 0.73

Mean change from baseline to 9 months

Group	Value	95% CI
Intervention Group	-0.66	-1.06 – -0.25
Control Group	0.68	0.16 – 1.20

BMIz Change Secondary · 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.

Mean change from baseline to 4

Group	Value	95% CI
Intervention Group	-0.06	-0.12 – -0.00
Control Group	0.07	-0.00 – 0.14

Mean change from baseline to 9

Group	Value	95% CI
Intervention Group	-0.23	-0.32 – -0.14
Control Group	0.10	-0.03 – 0.22

Weight Change Secondary · 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.

Mean change from baseline to 4

Group	Value	95% CI
Intervention Group	0.42	-0.28 – 1.12
Control Group	1.79	0.90 – 2.68

Mean change from baseline to 9

Group	Value	95% CI
Intervention Group	-0.15	-1.06 – 0.75
Control Group	2.76	1.45 – 4.07

Percent Body Fat Change Secondary · 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.

Mean change from baseline to 4

Group	Value	95% CI
Intervention Group	-0.19	-1.18 – 0.80
Control Group	0.80	-0.24 – 1.84

Mean change from baseline to 9

Group	Value	95% CI
Intervention Group	-1.46	-2.41 – -0.52
Control Group	0.24	-0.60 – 1.07

Waist Circumference Change Secondary · 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

Mean change from baseline to 4

Group	Value	95% CI
Intervention Group	-1.66	-3.02 – -0.29
Control Group	1.50	-0.01 – 3.01

Mean change from baseline to 9

Group	Value	95% CI
Intervention Group	-2.02	-3.80 – -0.23
Control Group	1.76	-0.25 – 3.77

Waist-to-height Ratio Change Secondary · Change from baseline at 4 months and 9 months

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

Mean change from baseline to 4

Group	Value	95% CI
Intervention Group	-0.01	-0.02 – -0.00
Control Group	0.01	-0.00 – 0.02

Mean change from baseline to 9

Group	Value	95% CI
Intervention Group	-0.02	-0.03 – -0.01
Control Group	0.01	-0.01 – 0.02

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of an adapted physical activity intervention on health-related physical fitness in adolescents with intellectual disability: a randomized controlled trial.
   Sun Y, Yu S, Wang A, Chan HC, et al · · 2022 · cited 11× · PMID 36585423 · DOI 10.1038/s41598-022-26024-1