Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability

NCT04554355 | Completed

• 1 other identifier: PHDSPE17482062
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. In addition, the effect of the intervention on blood pressure will be evaluated as the secondary outcomes.

Conditions

Obesity; Health-related Physical Fitness; Intellectual Disability

Keywords

Overweight; Obesity; Fitness; Adolescents; Intellectual disability

Outcome Measures

Primary Outcomes (33)

• 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.).

  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.).

  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.).

  up to 8 months

• BMI

  It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).

  up to 2 months

• BMI

  It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).

  up to 5 months

• BMI

  It will be calculated as weight (in kilograms) divided by the square of height (in metres) (kg/m2).

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  up to 8 months

Secondary Outcomes (3)

• Blood pressure (both diastolic and systolic blood pressure)

  up to 2 months

• Blood pressure (both diastolic and systolic blood pressure)

  up to 5 months

• Blood pressure (both diastolic and systolic blood pressure)

  up to 8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this group will receive a three-month PA intervention (60 minutes/session, two sessions/week).

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.

Interventions

School-based PA intervention BEHAVIORAL

Provide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels.

Intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Hong Kong Bapist University

Hong Kong, China

Location

Related Publications (2)

• 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.

  PMID: 36231316 DERIVED

• Wang 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.

  PMID: 33749611 DERIVED

MeSH Terms

Conditions

Obesity; Intellectual Disability; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Yang Gao, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

• Aiwei Wang, Master

  Hong Kong Baptist University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 1. those who entered data (student helpers) were exlcuded from fieldwork and intervention dilivery, data analysis and report writing. 2. after data entry, only the PI knew the values of the two groups and stored the data separately in another file with passwords requested for access. 3. data were analysed by a researcher, who was not involved in proposal writing and did not know which value means which group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: RCT

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 18, 2020
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)