ObesityNCT05724303
The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children
A study testing 8-week neuromuscular training program in people with Obesity and Childhood Obesity, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
Trial summary
Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity
- What is being tested?
- 8-week neuromuscular training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2023to 28 Jun 2024
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 8-11 years old
- overweight/obese children
Who cannot join
- children who have not given consent or had parental consent to participate
- children who fall outside of the selected age range
- children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Three Bridges
Ealing, London, UB2 4HT
About this study
Official title: The Effects of Integrative Neuromuscular Training on Physical Activity, Gait, Strength, and Body Composition in Overweight and Obese Children
Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.
- Conditions
- Obesity, Childhood Obesity
- Being tested
- 8-week neuromuscular training program
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week neuromuscular training programOther
Training program consisting of two neuromuscular training sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | 8-week neuromuscular training program Receives: Other: 8-week neuromuscular training program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat percentage
Bioelectrical impedance analysis of fat mass relative to body mass
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in fat free mass
Bioelectrical impedance analysis of fat free mass relative to body mass
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in body mass index (BMI)
BMI calculated with height measured barefoot on weight scales and height measured barefoot on Stadiometer and Z-score based on standard measures for age and gender. A reduction in BMI is a positive change.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in Hip 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in Knee 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in Ankle 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in Foot 3d gait analysis
Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in lower limb strength relative to body mass
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to body mass
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in lower limb strength relative to fat free mass
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to fat free mass
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical functioning: six-minute timed walk
Distance walked at a self-selected speed for six minutes
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical functioning: sit-to-stand test
The amount of repetitions of moving from a sitting position with knees at 90 degrees flexion to an upright standing position and return in one minute. Arms fixed across chest.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical functioning: timed up and go test
Time taken to rise from a seated position with knees at 90 degrees flexion and arms across chest, walk 3m and return back to seated position
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical functioning: single leg stand eyes open
Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical functioning: single leg stand eyed closed
Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical activity: percentage of time spent in sedentary activity levels
Accelerometer data captured and time spent in sedentary level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in physical activity: percentage of time spent in moderate to vigorous activity levels
Accelerometer data captured and time spent in moderate to vigorous level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Change in motivation towards physical activity
Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity
Measured: From baseline to end of 8-week training program and to end of 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start24 Feb 2023 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05724303
- Sponsor's protocol ID
- StMarysUC8
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2022
- Last updated
- 13 Feb 2023
- Results posted
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Integrative Neuromuscular Training on Physical Activity, Gait, Strength, and Body Composition in Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT05724303
- Acronym / sponsor ID
- StMarysUC8
- Conditions
- Obesity, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Study start
- 24 Feb 2023 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.
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: 8-week neuromuscular training program8-week neuromuscular training program |
| Control group | No intervention | – |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 8-11 years old
- overweight/obese children
Key exclusion criteria (3 listed)
- children who have not given consent or had parental consent to participate
- children who fall outside of the selected age range
- children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
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 |
|---|---|---|
| 8-week neuromuscular training programTraining program consisting of two neuromuscular training sessions per week | Other | Training group |
Primary outcome
Change in body fat percentage
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Bioelectrical impedance analysis of fat mass relative to body mass
Change in fat free mass
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Bioelectrical impedance analysis of fat free mass relative to body mass
Change in body mass index (BMI)
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
BMI calculated with height measured barefoot on weight scales and height measured barefoot on Stadiometer and Z-score based on standard measures for age and gender. A reduction in BMI is a positive change.
Change in Hip 3d gait analysis
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Knee 3d gait analysis
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Ankle 3d gait analysis
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Foot 3d gait analysis
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.
Change in lower limb strength relative to body mass
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to body mass
Change in lower limb strength relative to fat free mass
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to fat free mass
Change in physical functioning: six-minute timed walk
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Distance walked at a self-selected speed for six minutes
Change in physical functioning: sit-to-stand test
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
The amount of repetitions of moving from a sitting position with knees at 90 degrees flexion to an upright standing position and return in one minute. Arms fixed across chest.
Change in physical functioning: timed up and go test
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Time taken to rise from a seated position with knees at 90 degrees flexion and arms across chest, walk 3m and return back to seated position
Change in physical functioning: single leg stand eyes open
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion
Change in physical functioning: single leg stand eyed closed
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion
Change in physical activity: percentage of time spent in sedentary activity levels
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Accelerometer data captured and time spent in sedentary level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Change in physical activity: percentage of time spent in moderate to vigorous activity levels
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Accelerometer data captured and time spent in moderate to vigorous level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Change in motivation towards physical activity
Time frame: From baseline to end of 8-week training program and to end of 8-week follow-up
Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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.
Ryan Mahaffey, PhD principal investigator
St. Mary's University, Twickenham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week neuromuscular training program in people with Obesity and Childhood Obesity, run by St. Mary's University, Twickenham at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 13 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 1 site 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 Jourdana Durrell (07932743222, jourdana.durrell@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 fat percentage (time frame: From baseline to end of 8-week training program and to end of 8-week follow-up). The study lists 17 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 13 Feb 2023.