Clinical trial NCT03943108: Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
Collaborators: name: Oxford Brookes University
First posted: 2019-05-09
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* BMI over 95 th percentile for age
* Living in Major Mexico City area

Exclusion Criteria:

* Diabetic patients
* major physical disability

Primary outcomes:
measure: Gait
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
Secondary outcomes:
measure: 6 Minute Walk test (6MWT)
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Borg scale of perceived exertion
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Heart rate
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Respiratory rate
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: O2 saturation (mmHg) using a pulse Oximeter
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Blood Pressure (mmHg) using a baumanometer
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Insulin
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Fasting blood Glucose
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Hemoglobin A1C
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Total cholesterol
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Level of High-density lipoprotein (HDL) in blood
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Low-density lipoprotein (LDL)
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Triglycerides
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Alanine aminotransferase (ALT)
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Aspartate aminotransferase (AST)
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Homeostatic model assessment (HOMA) Index
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Body Mass Index (BMI)- Kg/m2
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Hip Circumference
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Waist Circumference
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Height
timeFrame: Baseline- Week 1
measure: Weight
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Leg Length
timeFrame: Baseline- Week 1
measure: Shoe Size
timeFrame: Baseline- Week 1
measure: Physical Activity- Accelerometer
timeFrame: 6 weeks
measure: Health Behaviour in School Aged Children (HSBC)- Eating Habits Questionnaire
timeFrame: 6 weeks
Other outcomes:
measure: Single item enjoyment of physical activity scale
timeFrame: 6 weeks, 3 and 6 month post-baseline follow-up
measure: Fatigue
timeFrame: 6 weeks, 3 months, 6 months
measure: Self-reported Physical activity- completion of daily exercise
timeFrame: 6 weeks, 3 months, 6 months
measure: Self-reported Physical activity- reason for no completion
timeFrame: 6 weeks, 3 months, 6 months
measure: Self-reported Physical activity- type of daily exercise
timeFrame: 6 weeks, 3 months, 6 months
measure: Self-reported Physical activity- time spent doing daily exercise
timeFrame: 6 weeks, 3 months, 6 months
Locations:
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico
Study officials:
affiliation: Oxford Brookes University
name: Arantza Aldea, PhD
role: PRINCIPAL_INVESTIGATOR
References: