Childhood ObesityPAIDOSNCT03943108
Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)
An observational study of Childhood Obesity, run by Dr Salvador Villalpando-Carrion at 1 site in Mexico.
Trial summary
One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Gait analysis
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 24 Jun 2019to 28 Feb 2020
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Individuals attending the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de Mexico Federico Gomez, living in the Major city area of Mexico City, Mexico.
Who may be able to join
- BMI over 95 th percentile for age
- Living in Major Mexico City area
Who cannot join
- Diabetic patients
- major physical disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Criticality Analysis of Diabetic Gait Within the PAIDOS Pediatric Clinic for Obese Children (PAIDOS: Pediatric Attention Integral and Dynamic for Obese Children Program)- A Feasibility Study
One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at risk of developing diabetes among children in Mexico.The study will investigate whether gait analysis can be used as a fast, reliable and cost effective way to detect individuals at risk of developing Type 2 Diabetes (T2DM) as early treatment could reduce the number of cases that develop into full T2DM.
Read the detailed description
This feasibility study aims to the do the following:
- To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.
- To design and set up a clinical feasibility study in a hospital (Hospital Infantil de Mexico) with adolescent patients on different clinical stages of type 2 Diabetes mellitus (DM).
- To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers.
- To use the feasibility study conducted in Mexico to develop a robust method using Gait analysis for diabetes prevention and management.
Participants will be selected from the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de México Federico Gómez, Mexico City, Mexico. Sixty participants will be selected and divided into three groups: 40 obese non-diabetic subjects, 10 with Type 2 Diabetes and 10 healthy subjects as controls. Obese participants within the Paidos clinic will undergo standard clinical care that includes dietary prescription of caloric intake according to height, 150 min weekly physical activity, group cognitive-behavioural intervention, 6 session of obesity awareness and educational program.
Gait will be recorded in all groups using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. The study will be repeated after 3-6 months as a follow up.
Data analysis will be performed in a semi-blind manner in order to test the efficacy of the criticality analysis Rate control of Chaos (RCC) model. In order to provide an objective measure of analysis, the anonymised data will be presented to the nonlinear RCC models, where results can be extracted and compared afterwards to known states.
- Conditions
- Childhood Obesity
- Being tested
- Gait analysis
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDiagnostic test
Gait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility.
| Study group | Role | What they receive |
|---|---|---|
| Obese teenagers within the PAIDOS clinic | Obese children within the PAIDOS clinic, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. Receives: Diagnostic Test: Gait analysis | |
| Healthy children | Healthy children living in Mexico City, Mexico. Receives: Diagnostic Test: Gait analysis | |
| Children with Type 2 Diabetes | Chjildren with Type 2 Diabetes attending the Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. Receives: Diagnostic Test: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Critical changes in walking control, stride frequency and length observed as individuals change speed using a movement sensor (Inertial Measurement Units (IMU) on the 4th vertebrae of the lumbar spine). Recorded during a 10 metre walk and 6 minute walk test
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Secondary outcomes (25)
6 Minute Walk test (6MWT)
Distance traveled during the 6MWT in metres
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Borg scale of perceived exertion
Recorded during the 6MWT
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Heart rate
Number of beats per minute (BPM) recorded before and after the 6MWT. Determination by palpation of radial, brachial, carotid, or other pulse or by auscultation in precordial area using a stethoscope.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Respiratory rate
Recorded before and after the 6MWT.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
O2 saturation (mmHg) using a pulse Oximeter
Recorded before and after the 6MWT.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Blood Pressure (mmHg) using a baumanometer
Recorded before and after the 6MWT
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Insulin
Measured in microUnit/milliliter (McU/mL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Fasting blood Glucose
Level of glucose after 12 hours fasting (overnight) measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Hemoglobin A1C
Also known as glycated hemoglobin test, and glycohemoglobin. Measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Total cholesterol
Measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Level of High-density lipoprotein (HDL) in blood
Measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Low-density lipoprotein (LDL)
Measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Triglycerides
Measured in milligram/deciliter (mg/dL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Alanine aminotransferase (ALT)
Measured in microUnit/milliliter (McU/mL) of blood.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Aspartate aminotransferase (AST)
Measured in millimoles Per Litre (mmol/L).
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Homeostatic model assessment (HOMA) Index
Index that allows the re-estimation of insulin resistance and Beta cell function through glucose concentration and plasma insulin during fasting state.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Body Mass Index (BMI)- Kg/m2
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Hip Circumference
Maximum perimeter of the hips at the gluteal level in centimeters (cm) using a tape measure.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Waist Circumference
Maximum circumference of the horizontal line between the last rib and the superior iliac crest in centimetres (cm) using a tape measure.
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Height
Centimeters (cm)
Measured: Baseline- Week 1
Weight
Kilograms (Kg)
Measured: 6 weeks, 3 and 6 month post-baseline follow-up
Leg Length
The distance from the anterior superior iliac spine to the medial malleolus in centimetres (cm) using a tape measure.
Measured: Baseline- Week 1
Shoe Size
Mexican Shoe Size (length of foot in centimeters (cm) using a tape measure).
Measured: Baseline- Week 1
Physical Activity- Accelerometer
Axivity AX3 Monitors
Measured: 6 weeks
Health Behaviour in School Aged Children (HSBC)- Eating Habits Questionnaire
Two multiple choice questions. 1 question assesses the frequency of breakfast consumption during weekdays and weekends. For weekdays- scores range from 1 ("I never have breakfast during weekdays") - 6 ("Five days"). For weekends scores range from 1 ("I never have breakfast during the weekend") to 3 ("I usually have breakfast on both weekend days (Saturday AND Sunday)". The higher the score the better the outcome.
1 question assesses food consumption frequency of fruit, vegetables, sweets and soft drinks that contain sugar.Scores range from 1 ("Never") to 7 ("Every day, more than once"). Higher scores on fruit and vegetables = better outcome. The higher the score on sweets and soft drinks the worse the outcome.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start24 Jun 2019
- Primary completion12 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Salvador Villalpando-Carrion
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor-investigator, Dr Salvador Villalpando-Carrion, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Arantza Aldea, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943108
- Sponsor's protocol ID
- HIM-060-09
- Acronym
- PAIDOS
- Status last verified
- Sep 2019
- First submitted
- 7 May 2019
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criticality Analysis of Diabetic Gait Within the PAIDOS Pediatric Clinic for Obese Children (PAIDOS: Pediatric Attention Integral and Dynamic for Obese Children Program)- A Feasibility Study
- ClinicalTrials.gov ID
- NCT03943108
- Acronym / sponsor ID
- PAIDOS / HIM-060-09
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr Salvador Villalpando-CarrionUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 May 2019 (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.
One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at risk of developing diabetes among children in Mexico.The study will investigate whether gait analysis can be used as a fast, reliable and cost effective way to detect individuals at risk of developing Type 2 Diabetes (T2DM) as early treatment could reduce the number of cases that develop into full T2DM.
Detailed description
This feasibility study aims to the do the following:
- To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.
- To design and set up a clinical feasibility study in a hospital (Hospital Infantil de Mexico) with adolescent patients on different clinical stages of type 2 Diabetes mellitus (DM).
- To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers.
- To use the feasibility study conducted in Mexico to develop a robust method using Gait analysis for diabetes prevention and management.
Participants will be selected from the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de México Federico Gómez, Mexico City, Mexico. Sixty participants will be selected and divided into three groups: 40 obese non-diabetic subjects, 10 with Type 2 Diabetes and 10 healthy subjects as controls. Obese participants within the Paidos clinic will undergo standard clinical care that includes dietary prescription of caloric intake according to height, 150 min weekly physical activity, group cognitive-behavioural intervention, 6 session of obesity awareness and educational program.
Gait will be recorded in all groups using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. The study will be repeated after 3-6 months as a follow up.
Data analysis will be performed in a semi-blind manner in order to test the efficacy of the criticality analysis Rate control of Chaos (RCC) model. In order to provide an objective measure of analysis, the anonymised data will be presented to the nonlinear RCC models, where results can be extracted and compared afterwards to known states.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese teenagers within the PAIDOS clinic | – | Diagnostic Test: Gait analysisObese children within the PAIDOS clinic, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. |
| Healthy children | – | Diagnostic Test: Gait analysisHealthy children living in Mexico City, Mexico. |
| Children with Type 2 Diabetes | – | Diagnostic Test: Gait analysisChjildren with Type 2 Diabetes attending the Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Individuals attending the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de Mexico Federico Gomez, living in the Major city area of Mexico City, Mexico.
Key inclusion criteria (2 listed)
- BMI over 95 th percentile for age
- Living in Major Mexico City area
Key exclusion criteria (2 listed)
- Diabetic patients
- major physical disability
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 |
|---|---|---|
| Gait analysisGait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. | Diagnostic test | Children with Type 2 Diabetes, Healthy children, Obese teenagers within the PAIDOS clinic |
Primary outcome
Gait
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Critical changes in walking control, stride frequency and length observed as individuals change speed using a movement sensor (Inertial Measurement Units (IMU) on the 4th vertebrae of the lumbar spine). Recorded during a 10 metre walk and 6 minute walk test
25 secondary outcomes
6 Minute Walk test (6MWT)
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Borg scale of perceived exertion
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Heart rate
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Respiratory rate
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
O2 saturation (mmHg) using a pulse Oximeter
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Blood Pressure (mmHg) using a baumanometer
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Insulin
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Fasting blood Glucose
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Hemoglobin A1C
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Total cholesterol
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Level of High-density lipoprotein (HDL) in blood
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Low-density lipoprotein (LDL)
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Triglycerides
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Alanine aminotransferase (ALT)
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Aspartate aminotransferase (AST)
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Homeostatic model assessment (HOMA) Index
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Body Mass Index (BMI)- Kg/m2
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Hip Circumference
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Waist Circumference
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Height
Time frame: Baseline- Week 1
Weight
Time frame: 6 weeks, 3 and 6 month post-baseline follow-up
Leg Length
Time frame: Baseline- Week 1
Shoe Size
Time frame: Baseline- Week 1
Physical Activity- Accelerometer
Time frame: 6 weeks
Health Behaviour in School Aged Children (HSBC)- Eating Habits Questionnaire
Time frame: 6 weeks
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 7 May 2020.
Related trials for 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
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Arantza Aldea, PhD principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Dr Salvador Villalpando-Carrion at 1 site in Mexico.
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 2 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 7 May 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 Mexico. 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?
Gait (time frame: 6 weeks, 3 and 6 month post-baseline follow-up). 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 7 May 2020.