ObesityNCT04554355
Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability
A study testing School-based PA intervention in people with Obesity and Health-related Physical Fitness, run by Hong Kong Baptist University at 1 site in China.
Trial summary
The proposed study will be a 12-week school-based physical activity (PA) program with a 2-armed randomized controlled trial (RCT) design. It will target overweight and obese children with intellectual disability (ID). The primary outcomes will be both fatness-related and fitness-related outcomes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Health-related Physical Fitness, Intellectual Disability
- What is being tested?
- School-based PA intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with mild ID;
- aged 12-18 years old;
- overweight or obese;
- at least one family member who is able to attend the program with them.
Who cannot join
- with physical disability;
- with a medical predisposition towards obesity (such as genetic syndrome) that could interfere with the results of the study;
- with contraindications for PA (e.g. severe heart disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a School-based Physical Activity Intervention for Fatness and Health-related Physical Fitness in Adolescents With Intellectual Disability
The proposed study will be a 12-week school-based physical activity (PA) program with a 2-armed randomized controlled trial (RCT) design. It will target overweight and obese children with intellectual disability (ID). The primary outcomes will be both fatness-related and fitness-related outcomes. In addition, the effect of the intervention on blood pressure will be evaluated as the secondary outcomes.
Read the detailed description
Childhood obesity and lower HRPF levels are major threats to public health. The previous research finds that children with ID are more vulnerable to be obesity and lower HRPF levels than general pediatric population. In addition, the transition from adolescence to young adulthood is recognized as a particularly high-risk period for weight gain. However, Interventions to reduce obesity and improve HRPF levels among adolescents with ID are scarce. The main purpose of this study is to implement and evaluate a fun game-based PA program to reduce overweight/obesity and improve health-related physical fitness (HRPF) levels among adolescents with ID (aged 12-18 years old).
The study consists of a 3-month intervention and a 3-month follow-up. Totally Forty-eight overweight/obese adolescents with mild intellectual disability (ID) will be recruited from special schools in China and then randomly assigned into two groups (n=24 for each group). Selection criteria for participants are: (1) children with mild ID; (2) aged 12-18 years old; (3) being overweight or obese; (4) without physical disability and other relevant health conditions. Participants in the experimental group will receive a fun game-based PA program (60 min/time, 2 sessions/week, 24 sessions totally) at school. No intervention will be provided to participants in the control group.
All participants in the two groups (N=48) will undertake repeated measurements on a set of study outcomes for three times. All measurements are non-invasive and no potential consequences are expected. In addition, questionnaires will be used to collect each participant's information of socio-demographic characteristics, physical activity level and eating habits (about 15 minutes).
The investigators expect the findings from the study would make up the knowledge gap and help eliminate existing health inequities among children with ID. It would serve as an example for use of other researchers, policy-makers, and the public to tackle off obesity among adolescents with ID in a global scale. If effective, this program would be welcomed and adopted by other special schools in the future. In addition, the effective model can also be extended to reach students with ID in normal schools.
- Being tested
- School-based PA intervention
- Keywords
- Overweight, Obesity, Fitness, Adolescents, Intellectual disability
- Medical subject headings
- Obesity, Intellectual Disability, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based PA interventionBehavioural
Provide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this group will receive a three-month PA intervention (60 minutes/session, two sessions/week). Receives: Behavioral: School-based PA intervention |
| Control group | No intervention | No intervention will be provided, participants in this group need to attend the regular school activities as normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
Measured: up to 2 months
Weight
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
Measured: up to 5 months
Weight
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
Measured: up to 8 months
BMI
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
Measured: up to 2 months
BMI
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
Measured: up to 5 months
BMI
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
Measured: up to 8 months
Waist circumference
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 2 months
Waist circumference
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 5 months
Waist circumference
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 8 months
Hip circumference
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 2 months
Hip circumference
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 5 months
Hip circumference
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Measured: up to 8 months
Waist to height ratio
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Measured: up to 2 months
Waist to height ratio
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Measured: up to 5 months
Waist to height ratio
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Measured: up to 8 months
Percent body fat
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
Measured: up to 2 months
Percent body fat
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
Measured: up to 5 months
Percent body fat
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
Measured: up to 8 months
6-min walk test
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
Measured: up to 2 months
6-min walk test
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
Measured: up to 5 months
6-min walk test
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
Measured: up to 8 months
30-second sit-to-stand
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
Measured: up to 2 months
30-second sit-to-stand
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
Measured: up to 5 months
30-second sit-to-stand
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
Measured: up to 8 months
One minute sit-up
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
Measured: up to 2 months
One minute sit-up
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
Measured: up to 5 months
One minute sit-up
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
Measured: up to 8 months
Handgrip strength
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Measured: up to 2 months
Handgrip strength
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Measured: up to 5 months
Handgrip strength
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Measured: up to 8 months
Sit to reach test
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
Measured: up to 2 months
Sit to reach test
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
Measured: up to 5 months
Sit to reach test
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
Measured: up to 8 months
Secondary outcomes (3)
Blood pressure (both diastolic and systolic blood pressure)
It will be measured using an Omron blood pressure monitor. (It will be calibrated before using.) During the test, the participant will be asked to sit quietly for about 5 minutes, and then to remove outer garments and roll up their shirt sleeves if necessary to bare the upper right arm. The measurements will be taken on the right arm whenever possible. The participant's arm will be resting on the desk so that the antecubital fossa is at the level of the heart and with the palm relaxed and facing upwards. Then, the cuff will be placed on the right arm, with the bottom edge 1-2 cm above the antecubital fossa. The top edge of the cuff cannot be restricted by clothing.
Measured: up to 2 months
Blood pressure (both diastolic and systolic blood pressure)
It will be measured using an Omron blood pressure monitor. (It will be calibrated before using.) During the test, the participant will be asked to sit quietly for about 5 minutes, and then to remove outer garments and roll up their shirt sleeves if necessary to bare the upper right arm. The measurements will be taken on the right arm whenever possible. The participant's arm will be resting on the desk so that the antecubital fossa is at the level of the heart and with the palm relaxed and facing upwards. Then, the cuff will be placed on the right arm, with the bottom edge 1-2 cm above the antecubital fossa. The top edge of the cuff cannot be restricted by clothing.
Measured: up to 5 months
Blood pressure (both diastolic and systolic blood pressure)
It will be measured using an Omron blood pressure monitor. (It will be calibrated before using.) During the test, the participant will be asked to sit quietly for about 5 minutes, and then to remove outer garments and roll up their shirt sleeves if necessary to bare the upper right arm. The measurements will be taken on the right arm whenever possible. The participant's arm will be resting on the desk so that the antecubital fossa is at the level of the heart and with the palm relaxed and facing upwards. Then, the cuff will be placed on the right arm, with the bottom edge 1-2 cm above the antecubital fossa. The top edge of the cuff cannot be restricted by clothing.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Sep 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yang, Hong Kong Baptist University
- Investigators
- Yang Gao, PhD, Principal investigator, Hong Kong Baptist UniversityAiwei Wang, Master, Study director, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554355
- Sponsor's protocol ID
- PHDSPE17482062
- Status last verified
- Dec 2020
- First submitted
- 10 Sep 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang A, Bu D, Yu S, Sun Y, Wang J, Lee TCT, Baker JS, Gao Y. Effects of a School-Based Physical Activity Intervention for Obesity, Health-Related Physical Fitness, and Blood Pressure in Children with Intellectual Disability: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 22;19(19):12015. doi: 10.3390/ijerph191912015.
PubMed 36231316Wang A, Gao Y, Wang J, Tong TK, Sun Y, Yu S, Zhao H, Zou D, Zhang Z, Qi Y, Zuo N, Bu D, Zhang D, Xie Y, Baker JS. Effects of a School-Based Physical Activity Intervention for Obesity and Health-Related Physical Fitness in Adolescents With Intellectual Disability: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 22;10(3):e25838. doi: 10.2196/25838.
PubMed 33749611
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a School-based Physical Activity Intervention for Fatness and Health-related Physical Fitness in Adolescents With Intellectual Disability
- ClinicalTrials.gov ID
- NCT04554355
- Acronym / sponsor ID
- PHDSPE17482062
- Keywords
- Overweight, Obesity, Fitness, Adolescents, Intellectual disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will be a 12-week school-based physical activity (PA) program with a 2-armed randomized controlled trial (RCT) design. It will target overweight and obese children with intellectual disability (ID). The primary outcomes will be both fatness-related and fitness-related outcomes. In addition, the effect of the intervention on blood pressure will be evaluated as the secondary outcomes.
Detailed description
Childhood obesity and lower HRPF levels are major threats to public health. The previous research finds that children with ID are more vulnerable to be obesity and lower HRPF levels than general pediatric population. In addition, the transition from adolescence to young adulthood is recognized as a particularly high-risk period for weight gain. However, Interventions to reduce obesity and improve HRPF levels among adolescents with ID are scarce. The main purpose of this study is to implement and evaluate a fun game-based PA program to reduce overweight/obesity and improve health-related physical fitness (HRPF) levels among adolescents with ID (aged 12-18 years old).
The study consists of a 3-month intervention and a 3-month follow-up. Totally Forty-eight overweight/obese adolescents with mild intellectual disability (ID) will be recruited from special schools in China and then randomly assigned into two groups (n=24 for each group). Selection criteria for participants are: (1) children with mild ID; (2) aged 12-18 years old; (3) being overweight or obese; (4) without physical disability and other relevant health conditions. Participants in the experimental group will receive a fun game-based PA program (60 min/time, 2 sessions/week, 24 sessions totally) at school. No intervention will be provided to participants in the control group.
All participants in the two groups (N=48) will undertake repeated measurements on a set of study outcomes for three times. All measurements are non-invasive and no potential consequences are expected. In addition, questionnaires will be used to collect each participant's information of socio-demographic characteristics, physical activity level and eating habits (about 15 minutes).
The investigators expect the findings from the study would make up the knowledge gap and help eliminate existing health inequities among children with ID. It would serve as an example for use of other researchers, policy-makers, and the public to tackle off obesity among adolescents with ID in a global scale. If effective, this program would be welcomed and adopted by other special schools in the future. In addition, the effective model can also be extended to reach students with ID in normal schools.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: School-based PA interventionParticipants in this group will receive a three-month PA intervention (60 minutes/session, two sessions/week). |
| Control group | No intervention | –No intervention will be provided, participants in this group need to attend the regular school activities as normal. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- children with mild ID;
- aged 12-18 years old;
- overweight or obese;
- at least one family member who is able to attend the program with them.
Key exclusion criteria (3 listed)
- with physical disability;
- with a medical predisposition towards obesity (such as genetic syndrome) that could interfere with the results of the study;
- with contraindications for PA (e.g. severe heart disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based PA interventionProvide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels. | Behavioural | Intervention group |
Primary outcome
Weight
Time frame: up to 2 months
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
Weight
Time frame: up to 5 months
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
Weight
Time frame: up to 8 months
It will be measured with a TANITA digital scale (TBF-410), which is accurate to 0.1 kg. The scale will be cleared before each participant is weighed, and the participants will be asked to remove any 'heavy' items from their pockets (keys, wallets etc.) and remove any heavy items of clothing or apparel (jackets, shoes, woollen jerseys etc.).
BMI
Time frame: up to 2 months
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
BMI
Time frame: up to 5 months
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
BMI
Time frame: up to 8 months
It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).
Waist circumference
Time frame: up to 2 months
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Waist circumference
Time frame: up to 5 months
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Waist circumference
Time frame: up to 8 months
It will be measured midway between the lowest rib margin and the top of the iliac crest at the end of a gentle expiration. The measure will be performed with a flexible metre ribbon accurate to 0.1 cm.
Hip circumference
Time frame: up to 2 months
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Hip circumference
Time frame: up to 5 months
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Hip circumference
Time frame: up to 8 months
It will be measured at the widest part of the body below the waist. The measurement of the waist circumference will be performed with a flexible metre ribbon accurate to 0.1 cm.
Waist to height ratio
Time frame: up to 2 months
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Waist to height ratio
Time frame: up to 5 months
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Waist to height ratio
Time frame: up to 8 months
The waist to height ratio will be calculated as waist circumference (in centimetres) divided by height (in centimetres).
Percent body fat
Time frame: up to 2 months
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
Percent body fat
Time frame: up to 5 months
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
Percent body fat
Time frame: up to 8 months
The percent body fat will be estimated with the TANITA digital scale (TBF-410) using foot-to-foot bioelectrical impedance analysis (BIA). After entering the participant's gender, race, height and age, the participant will be instructed to stand with bare feet on the metal footplates. The data will be displayed automatically.
6-min walk test
Time frame: up to 2 months
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
6-min walk test
Time frame: up to 5 months
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
6-min walk test
Time frame: up to 8 months
Testing procedures will follow Chow's study protocol (2018). The participants will be instructed and encouraged to cover the greatest possible distance on a flat surface 25 m in length. They will be instructed to keep a steady pace, whether running or walking. At the end of the test, the participants will be instructed to keep walking to aid in the recovery process. The distance will be measured by the number of laps around the track, adding extra distance as required (VOLEK et al., 2003). A trained examiner will measure and record the distance covered by each participant. Each participant will be assigned a trained partner (university student helper) based on his or her special physical condition and cognitive ability to give verbal direction and encouragement during the test.
30-second sit-to-stand
Time frame: up to 2 months
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
30-second sit-to-stand
Time frame: up to 5 months
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
30-second sit-to-stand
Time frame: up to 8 months
It will be used to assess participants' lower limb strength and endurance. It measures the maximum number of times a participant can rise to a full standing position from a seated position in a 30-second period, without pushing off with their arms. This test is administered using a school chair without arms, with a seat height around 14 inches (35.6 cm). The back of the chair will be placed against a wall to prevent it from moving. The participants will be instructed to sit in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.
One minute sit-up
Time frame: up to 2 months
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
One minute sit-up
Time frame: up to 5 months
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
One minute sit-up
Time frame: up to 8 months
will be adopted to evaluate participants' abdominal muscular strength and endurance. The task is to perform as many sit-ups as possible in one minute, or until the participant experiences muscle fatigue and cannot try any more. The participants will be instructed to cross their arms on their chests with hands on shoulders, and to tighten their abdominal muscles and rise up to touch elbows to thighs. Then, they return to the start position and repeat.
Handgrip strength
Time frame: up to 2 months
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Handgrip strength
Time frame: up to 5 months
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Handgrip strength
Time frame: up to 8 months
It will be used to assess participants' hand and forearm muscular strength. During the test, the participant will be instructed to adopt a standing position, with arms at his/her side, not touching the body. The participant will be asked to squeeze the dynamometer with as much force as possible, being careful to squeeze only once for each measurement. Three trials will be made with a pause of 10-20 s between each to avoid the effects of muscular fatigue. Right and left hands will be alternated. The best score will be recorded.
Sit to reach test
Time frame: up to 2 months
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
Sit to reach test
Time frame: up to 5 months
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
Sit to reach test
Time frame: up to 8 months
Each participant will begin the test by removing his/her shoes (very thin footwear will be permitted) and sitting down at the test apparatus. One leg will be fully extended with the foot flat against the end of the testing instrument. The other knee will be bent, with the sole of the foot flat on the floor 5-8 cm to the side of the straight knee. The arms will be extended forward over the measuring scale with hands palms down, one on top of the other. Each participant will be instructed to reach directly forward with both hands along the scale four times and to hold the position of the fourth reach for at least 1 s. After measuring one side, the participant will be asked to switch the position of his/her legs and reach again. The participant can allow the bent knee to move to the side if necessary as the body moves forward.
3 secondary outcomes
Blood pressure (both diastolic and systolic blood pressure)
Time frame: up to 2 months
Blood pressure (both diastolic and systolic blood pressure)
Time frame: up to 5 months
Blood pressure (both diastolic and systolic blood pressure)
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 36231316Wang A, Bu D, Yu S, Sun Y, Wang J, Lee TCT, Baker JS, Gao Y. Effects of a School-Based Physical Activity Intervention for Obesity, Health-Related Physical Fitness, and Blood Pressure in Children with Intellectual Disability: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 22;19(19):12015. doi: 10.3390/ijerph191912015.
- Derived from this study: PubMed 33749611Wang A, Gao Y, Wang J, Tong TK, Sun Y, Yu S, Zhao H, Zou D, Zhang Z, Qi Y, Zuo N, Bu D, Zhang D, Xie Y, Baker JS. Effects of a School-Based Physical Activity Intervention for Obesity and Health-Related Physical Fitness in Adolescents With Intellectual Disability: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 22;10(3):e25838. doi: 10.2196/25838.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Gao, PhD principal investigator
Hong Kong Baptist University
Aiwei Wang, Master study director
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based PA intervention in people with Obesity and Health-related Physical Fitness, run by Hong Kong Baptist University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: up to 2 months). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554355, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.