Trial Outcomes & Findings for School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong (NCT NCT04463069)
NCT ID: NCT04463069
Last Updated: 2022-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Change from baseline at 4 months and 9 months
Results posted on
2022-05-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Control Group
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
45
|
|
Overall Study
COMPLETED
|
39
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
23
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
10
|
|
Overall Study
Participants' parents refused to participate after learning the assignment results
|
0
|
13
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=39 Participants
|
22 Participants
n=22 Participants
|
61 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
8 Participants
n=22 Participants
|
16 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=39 Participants
|
14 Participants
n=22 Participants
|
45 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
39 participants
n=39 Participants
|
22 participants
n=22 Participants
|
61 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsThe 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.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
BMI Change
Mean change from baseline to 4 months
|
-0.14 kg/m2
Interval -0.44 to 0.16
|
0.42 kg/m2
Interval 0.12 to 0.73
|
|
BMI Change
Mean change from baseline to 9 months
|
-0.66 kg/m2
Interval -1.06 to -0.25
|
0.68 kg/m2
Interval 0.16 to 1.2
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsThe 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.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
BMIz Change
Mean change from baseline to 4
|
-0.06 z-score
Interval -0.12 to 0.0
|
0.07 z-score
Interval 0.0 to 0.14
|
|
BMIz Change
Mean change from baseline to 9
|
-0.23 z-score
Interval -0.32 to -0.14
|
0.10 z-score
Interval -0.03 to 0.22
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsWeight 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.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Weight Change
Mean change from baseline to 4
|
0.42 kg
Interval -0.28 to 1.12
|
1.79 kg
Interval 0.9 to 2.68
|
|
Weight Change
Mean change from baseline to 9
|
-0.15 kg
Interval -1.06 to 0.75
|
2.76 kg
Interval 1.45 to 4.07
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsPercent body fat was measured with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Percent Body Fat Change
Mean change from baseline to 4
|
-0.19 percent change
Interval -1.18 to 0.8
|
0.80 percent change
Interval -0.24 to 1.84
|
|
Percent Body Fat Change
Mean change from baseline to 9
|
-1.46 percent change
Interval -2.41 to -0.52
|
0.24 percent change
Interval -0.6 to 1.07
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsWaist 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
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Waist Circumference Change
Mean change from baseline to 4
|
-1.66 cm
Interval -3.02 to -0.29
|
1.50 cm
Interval -0.01 to 3.01
|
|
Waist Circumference Change
Mean change from baseline to 9
|
-2.02 cm
Interval -3.8 to -0.23
|
1.76 cm
Interval -0.25 to 3.77
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsWaist-to-height ratio was calculated by dividing the waist circumference by the height.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=22 Participants
Participants in the control group received no intervention in the study time period.
|
|---|---|---|
|
Waist-to-height Ratio Change
Mean change from baseline to 4
|
-0.01 ratio
Interval -0.02 to 0.0
|
0.01 ratio
Interval 0.0 to 0.02
|
|
Waist-to-height Ratio Change
Mean change from baseline to 9
|
-0.02 ratio
Interval -0.03 to -0.01
|
0.01 ratio
Interval -0.01 to 0.02
|
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsCardiorespiratory 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline at 4 months and 9 monthsFlexibility was measured by the sit-and-reach test.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place