Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)

Childhood Obesity Clinical Trial

— PAIDOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943108
• Other study ID #: HIM-060-09
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2019
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Description:

This feasibility study aims to the do the following:

1. To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.

2. 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).

3. To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 28, 2020
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• BMI over 95 th percentile for age

• Living in Major Mexico City area

Exclusion Criteria:

• Diabetic patients

• major physical disability

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Diagnostic Test:
• Gait analysis
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.

Locations

Country	Name	City	State
Mexico	Hospital Infantil de Mexico	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Dr Salvador Villalpando-Carrion	Oxford Brookes University

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single item enjoyment of physical activity scale	During each clinic visit the participant will be asked the following, single answer question (translated into Spanish): How much would you agree with the following? "I enjoy being physically active"; The answer is a seven point scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). The higher the score the better the outcome.	6 weeks, 3 and 6 month post-baseline follow-up
Other	Fatigue	The children will be asked the following question to assess fatigue levels (translated into spanish): "On average, what fraction of the day do you feel tired or very tired?"; 1) None/nothing, 2) A quarter of the day, 3) Half of the day, 4) Three quarters of the day, 5) All of the day; The higher the score the worse the fatigue outcome.	6 weeks, 3 months, 6 months
Other	Self-reported Physical activity- completion of daily exercise	The children are asked whether they have completed their daily exercise using an online survey (as part of the PAIDOS program). The following is translated into Spanish: Have you completed the activity / exercises today? Yes/No	6 weeks, 3 months, 6 months
Other	Self-reported Physical activity- reason for no completion	The children are asked the reason for not completing their daily exercise using an online survey (as part of the PAIDOS program). The following question is translated into Spanish: If you have answered no, indicate why: I was sick; My muscles or joints hurt; Today was one of my days of rest; I had an event; I did not want to do it (indicate the reason)	6 weeks, 3 months, 6 months
Other	Self-reported Physical activity- type of daily exercise	The children are asked the type of exercise they did that day using an online survey (as part of the PAIDOS program). The following open text box question is translated into Spanish: What physical activity did you do today?	6 weeks, 3 months, 6 months
Other	Self-reported Physical activity- time spent doing daily exercise	The children are asked the time spent doing the exercise in minutes using an online survey (as part of the PAIDOS program). The following question is translated into Spanish: How much time did you spend doing this physical activity in minutes?; Higher number of minutes equals a better outcome.	6 weeks, 3 months, 6 months
Primary	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	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	6 Minute Walk test (6MWT)	Distance traveled during the 6MWT in metres	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Borg scale of perceived exertion	Recorded during the 6MWT	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	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.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Respiratory rate	Recorded before and after the 6MWT.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	O2 saturation (mmHg) using a pulse Oximeter	Recorded before and after the 6MWT.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Blood Pressure (mmHg) using a baumanometer	Recorded before and after the 6MWT	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Insulin	Measured in microUnit/milliliter (McU/mL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Fasting blood Glucose	Level of glucose after 12 hours fasting (overnight) measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Hemoglobin A1C	Also known as glycated hemoglobin test, and glycohemoglobin. Measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Total cholesterol	Measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Level of High-density lipoprotein (HDL) in blood	Measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Low-density lipoprotein (LDL)	Measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Triglycerides	Measured in milligram/deciliter (mg/dL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Alanine aminotransferase (ALT)	Measured in microUnit/milliliter (McU/mL) of blood.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Aspartate aminotransferase (AST)	Measured in millimoles Per Litre (mmol/L).	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	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.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Body Mass Index (BMI)- Kg/m2		6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Hip Circumference	Maximum perimeter of the hips at the gluteal level in centimeters (cm) using a tape measure.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Waist Circumference	Maximum circumference of the horizontal line between the last rib and the superior iliac crest in centimetres (cm) using a tape measure.	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Height	Centimeters (cm)	Baseline- Week 1
Secondary	Weight	Kilograms (Kg)	6 weeks, 3 and 6 month post-baseline follow-up
Secondary	Leg Length	The distance from the anterior superior iliac spine to the medial malleolus in centimetres (cm) using a tape measure.	Baseline- Week 1
Secondary	Shoe Size	Mexican Shoe Size (length of foot in centimeters (cm) using a tape measure).	Baseline- Week 1
Secondary	Physical Activity- Accelerometer	Axivity AX3 Monitors	6 weeks
Secondary	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.	6 weeks