Obesity, ChildhoodNCT05665621
The Effects of Strength and Balance Training on Physical Function in Overweight Children
A study testing Eight-week in-school strength and balance training program in people with Obesity, Childhood, run by St. Mary's University, Twickenham at 3 sites in United Kingdom.
Trial summary
This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Eight-week in-school strength and balance training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 13 Mar 2023to 13 Aug 2023
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight or obese
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Orchard Primary school
Hounslow, Greater London, TW4 5JW
- Recruiting
Beavers Primary School
Hounslow, London, TW4 6HR
- Recruiting
Isleworth Town Primary School
Isleworth, Greater London, TW7 6AB
About this study
Official title: The Effect of Strength and Combined Balance Training Intervention Programme on Physical Function, Physical Activity, and Musculoskeletal Health in Children With Overweight and Obesity
This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question[s] it aims to answer are:
- Is the school-based exercise programme effective in improving lower limb muscular strength and balance control?
- How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks.
Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.
- Conditions
- Obesity, Childhood
- Being tested
- Eight-week in-school strength and balance training program
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eight-week in-school strength and balance training programOther
Training program consisting of two 1-hour strength and balance training sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Eight-week in-school strength and balance training program Receives: Other: Eight-week in-school strength and balance training program |
| Control | No intervention | No intervention, normal activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index Z-Score
Body mass index will be calculated as body mass (kg) / height (m)2. Body mass will be measured using weighing scales and height by stadiometer whilst participants are barefooted with simple clothing (shorts and t-shirt). Z-scores denote the standard deviations that BMI for gender and height are from the mean of United Kingdom child reference curves. A higher z-score means greater BMI than the mean for child gender and height.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in body fat percentage
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). The percentage of body fat will be calculated as (Fat Mass (kg)/Body Mass(kg))*100.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in fat free mass (kg)
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). Fat-free mass will be calculated as Body Mass (kg) - fat mass (kg).
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in lower limb 3D gait.
Joint angles, moments, and power waveforms of hip, knee and ankle in three dimensions during the stance phase of self-paced walking. Change in lower limb 3D gait will be determined via a previously validated marker set for obese children, time normalised to 100% of stance phase, and moment and power will be dimensionless normalised to body mass and leg length.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in 3D foot in gait.
The angle of the forefoot, midfoot, rearfoot and shank in three dimensions during the stance phase of self-paced walking. Change in foot 3D gait will be determined via a previously validated marker set for obese children, and time normalised to 100% of the stance phase.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in lower limb muscular strength relative to body mass.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to body mass.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in lower limb muscular strength relative to fat free mass.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to fat-free mass.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in six minute walk distance.
The maximal distance walked in six minutes will be recorded in meters.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in sit to stand repetitions
The maximal number of times participants are able to stand up and sit down in one minute. The stool used will be adjusted so the participant's knee is at 90 degrees when seated, and arms will be placed across the chest.
Measured: Baseline to end of 8-week intervention and to end of 8-week follow up period.
Change in timed up and go time
The time (seconds) it takes participants to stand from seated (knees 90 degrees), arms across chest, walk 3m turn and go back to seating.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in single leg stance time
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in single leg stance time with eye closed
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist and with their eyes closed. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in percentage of time spent in sedentary activity.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times of sedentary behaviour. Total time in mins will be divided by total wear time to get percentage of time in sedentary activity.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in percentage of time spent in moderate to vigorous activity.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times spent in moderate to vigorous physical activity. Total time in mins will be divided by total wear time to get the percentage of time in moderate to vigorous activity.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in total vector magnitude counts
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Vector magnitude counts are a total raw measure of movement.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in quality of life score.
Previously validated Paediatric Quality of Life (PedsQL; physical function section only) will be completed on a 5-point Likert scale and scored. Items are reversed, scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed; mean score = Sum of the items over the number of items answered. A higher score denotes a better quality of life whilst a lower score suggests a poorer quality of life.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in pain reported now
Previously validated paediatric pain questionnaire visual analogue scale for present pain. 10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in worst pain
Previously validated paediatric pain questionnaire visual analogue scale for worst pain in last seven days.10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in physical activity enjoyment scale
Previously validated 16-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). Negatively worded sites are reverse scored, and the overall enjoyment for physical activity score is determined by summing all items. A higher score means greater enjoyment of physical activity.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Change in basic psychological needs in exercise scale score
Previously validated 18-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). An average score for each subdivision of autonomy, competence, relatedness and teacher relatedness is calculated. A higher score means positive support felt for each subdivision.
Measured: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start13 Mar 2023 (estimated)
- Primary completion13 Aug 2023 (estimated)
- Study completion13 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Mahaffey, PhD, Principal investigator, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665621
- Sponsor's protocol ID
- StMarysUC7
- Status last verified
- Feb 2023
- First submitted
- 16 Dec 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Strength and Combined Balance Training Intervention Programme on Physical Function, Physical Activity, and Musculoskeletal Health in Children With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT05665621
- Acronym / sponsor ID
- StMarysUC7
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Study start
- 13 Mar 2023 (estimated)
- Primary completion
- 13 Aug 2023 (estimated)
- Study completion
- 13 Aug 2023 (estimated)
- First posted
- 27 Dec 2022 (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.
This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question[s] it aims to answer are:
- Is the school-based exercise programme effective in improving lower limb muscular strength and balance control?
- How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks.
Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Eight-week in-school strength and balance training programEight-week in-school strength and balance training program |
| Control | No intervention | –No intervention, normal activities. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Overweight or obese
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Eight-week in-school strength and balance training programTraining program consisting of two 1-hour strength and balance training sessions per week. | Other | Training group |
Primary outcome
Change in Body Mass Index Z-Score
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Body mass index will be calculated as body mass (kg) / height (m)2. Body mass will be measured using weighing scales and height by stadiometer whilst participants are barefooted with simple clothing (shorts and t-shirt). Z-scores denote the standard deviations that BMI for gender and height are from the mean of United Kingdom child reference curves. A higher z-score means greater BMI than the mean for child gender and height.
Change in body fat percentage
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). The percentage of body fat will be calculated as (Fat Mass (kg)/Body Mass(kg))*100.
Change in fat free mass (kg)
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). Fat-free mass will be calculated as Body Mass (kg) - fat mass (kg).
Change in lower limb 3D gait.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Joint angles, moments, and power waveforms of hip, knee and ankle in three dimensions during the stance phase of self-paced walking. Change in lower limb 3D gait will be determined via a previously validated marker set for obese children, time normalised to 100% of stance phase, and moment and power will be dimensionless normalised to body mass and leg length.
Change in 3D foot in gait.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
The angle of the forefoot, midfoot, rearfoot and shank in three dimensions during the stance phase of self-paced walking. Change in foot 3D gait will be determined via a previously validated marker set for obese children, and time normalised to 100% of the stance phase.
Change in lower limb muscular strength relative to body mass.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to body mass.
Change in lower limb muscular strength relative to fat free mass.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to fat-free mass.
Change in six minute walk distance.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
The maximal distance walked in six minutes will be recorded in meters.
Change in sit to stand repetitions
Time frame: Baseline to end of 8-week intervention and to end of 8-week follow up period.
The maximal number of times participants are able to stand up and sit down in one minute. The stool used will be adjusted so the participant's knee is at 90 degrees when seated, and arms will be placed across the chest.
Change in timed up and go time
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
The time (seconds) it takes participants to stand from seated (knees 90 degrees), arms across chest, walk 3m turn and go back to seating.
Change in single leg stance time
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Change in single leg stance time with eye closed
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist and with their eyes closed. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Change in percentage of time spent in sedentary activity.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times of sedentary behaviour. Total time in mins will be divided by total wear time to get percentage of time in sedentary activity.
Change in percentage of time spent in moderate to vigorous activity.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times spent in moderate to vigorous physical activity. Total time in mins will be divided by total wear time to get the percentage of time in moderate to vigorous activity.
Change in total vector magnitude counts
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Vector magnitude counts are a total raw measure of movement.
Change in quality of life score.
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Previously validated Paediatric Quality of Life (PedsQL; physical function section only) will be completed on a 5-point Likert scale and scored. Items are reversed, scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed; mean score = Sum of the items over the number of items answered. A higher score denotes a better quality of life whilst a lower score suggests a poorer quality of life.
Change in pain reported now
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Previously validated paediatric pain questionnaire visual analogue scale for present pain. 10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Change in worst pain
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Previously validated paediatric pain questionnaire visual analogue scale for worst pain in last seven days.10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Change in physical activity enjoyment scale
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Previously validated 16-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). Negatively worded sites are reverse scored, and the overall enjoyment for physical activity score is determined by summing all items. A higher score means greater enjoyment of physical activity.
Change in basic psychological needs in exercise scale score
Time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Previously validated 18-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). An average score for each subdivision of autonomy, competence, relatedness and teacher relatedness is calculated. A higher score means positive support felt for each subdivision.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
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.
Ryan Mahaffey, PhD principal investigator
St. Mary's University, Twickenham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eight-week in-school strength and balance training program in people with Obesity, Childhood, run by St. Mary's University, Twickenham at 3 sites in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Le Warne, MRes (020 8240 4034, megan.lewarne@stmarys.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index Z-Score (time frame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.