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

NCT03943108 | Completed DMC

• 1 other identifier: HIM-060-09
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• 6 Minute Walk test (6MWT)

  6 weeks, 3 and 6 month post-baseline follow-up

• Borg scale of perceived exertion

  6 weeks, 3 and 6 month post-baseline follow-up

• Heart rate

  6 weeks, 3 and 6 month post-baseline follow-up

• Respiratory rate

  6 weeks, 3 and 6 month post-baseline follow-up

• O2 saturation (mmHg) using a pulse Oximeter

  6 weeks, 3 and 6 month post-baseline follow-up

Other Outcomes (6)

• Single item enjoyment of physical activity scale

  6 weeks, 3 and 6 month post-baseline follow-up

• Fatigue

  6 weeks, 3 months, 6 months

• Self-reported Physical activity- completion of daily exercise

  6 weeks, 3 months, 6 months

Study Arms (3)

Obese teenagers within the PAIDOS clinic

Obese children within the PAIDOS clinic, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico.

Diagnostic Test: Gait analysis

Healthy children

Healthy children living in Mexico City, Mexico.

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.

Diagnostic Test: Gait analysis

Interventions

Gait analysis DIAGNOSTIC_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.

Children with Type 2 Diabetes; Healthy children; Obese teenagers within the PAIDOS clinic

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Diabetic patients
• major physical disability

Sponsors & Collaborators

• Dr Salvador Villalpando-Carrion: lead
• Oxford Brookes University: collaborator

Study Sites (1)

Hospital Infantil de Mexico

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Arantza Aldea, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pediatric Gastroenterology and Nutrition

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: June 24, 2019
• Primary Completion: December 12, 2019
• Study Completion: February 28, 2020
• Last Updated: May 7, 2020

Record last verified: 2019-09

Locations

ME (1)