Cardio-Metabolic Risk Evaluation in Overweight and Obese Children

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 1 year to 18 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

Study population: The group or cohort of patients will be selected form the population that addresses the primary care clinic - pediatric center - Neoped.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Complex Assessment and Monitoring of Cardio-metabolic Risk in Overweight and Obese Children

Conditions

Pediatric Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver, Atherosclerosis, Psychology, Cardiometabolic Syndrome

Being tested

History and Clinical evaluation, Biological evaluation of the metabolic syndrome and components, Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage, Nutritional assessment, Psychological evaluation of the impact of obesity/overweight

Keywords

Pediatric MetS, NAFLD, CIMT, Nutrition, Psychology

Medical subject headings

Pediatric Obesity, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• History and Clinical evaluationOther

  HISTORY and CLINICAL EVALUATION and recording of the following parameters:

  • Gestational Age
  • Birth Weight
  • Gender
  • Weaning habits
  • Anthropometric indices: actual age; actual weight; actual height; body mass index BMI (kg/m2) + percentile; waist circumference; age for height; weight for height; height for age; height standard deviation score (SDS)
  • Vital parameters: heart rate (beats/min); respiratory rate (breaths/min); blood pressure (mmHg)
  • Adipose tissue
  • Subcutaneous fat tissue distribution
  • Acanthosis Nigricans
  • Stretch marks (striae)
  • Tanner Puberty Stage

• Biological evaluation of the metabolic syndrome and componentsDiagnostic test

  LABORATORY INVESTIGATIONS will include:

  • Lipid Profile: total cholesterol (mmol/L); LDL - cholesterol (mmol/L); HDL - cholesterol (mmol/L); triglycerides (mmol/L)
  • Glucose - Insulin Profile: HbA1c (%); serum glucose (mmol/L); insulinemia (µUI/mL); HOMA Index
  • Liver Function: alanine aminotransferase (ALT or TGP) (U/L); gamma glutamyl transferase (GGT) (U/L)
  • Cardio-Vascular Risk - Inflammation - Oxidative Stress: ultrasensitive C-reactive protein (ng/mL); leptin (ng/mL); adiponectin (ng/mL); serum selenium (μg/L); glutathione peroxidase (GPx) (U/L)

• Ultrasound evaluation of subclinical atherosclerosis and visceral fat storageDiagnostic test

  ULTRASOUND EVALUATION by:

  • Carotid Intima-Media Thickness (cIMT) Measurement using B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) with a high frequency linear array probe (5-13 MHz) and a semi-automated software (Auto IMT+), according to the Mannheim Consensus
  • Measurements of Visceral-to-Subcutaneous-Fat Ratio using B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) with a 7.5 (12) MHz linear transducer for subcutaneous fat and a 3.5 MHz convex transducer for visceral fat measurement
  • Ultrasound Quantification of Hepatic Steatosis: assessed with B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) using 3.5 MHz convex transducer; increased liver echogenicity, blurring of vascular margins and increased acoustic attenuation are the parameters considered in the quantification of hepatic steatosis

• Nutritional assessmentOther

  NUTRITION CONSULT Initial consult will include: food habits survey aiming at identifying the nutritional factors that led to an increased Body Mass Index (BMI) and recommendations At reevaluations the food diary of the patients will be evaluated and recommendations will be adapted accordingly.

  The final visit will include evaluation of the food diary looking to identify the factors that have or have not helped to normalize BMI in order to recommend a long-term healthy lifestyle.

• Psychological evaluation of the impact of obesity/overweightBehavioural

  PSYCHOLOGICAL ASSESSMENT by:

  Evaluation of pediatric health-related quality of life will be assessed with Pediatric Quality of Life Inventory (PedsQL). The questionnaire has 23 items and undertakes the four types of functioning: physical, emotional, social, and educational. It can be filled in by children as well as parents. Higher scores indicate better health-related quality of life.

  Another questionnaire that will be used is the the Rosenberg Self-Esteem Scale. It is composed of 10 questions and measures positive and negative feelings about the self. The answer range is from strongly agree to strongly disagree. A higher score means higher self-esteem.

  Drawing in children is a communicative tool, many times more than reading or language. It can measure the image of the self and the image of the others and is representative of the unconscious.

  Questionnaires and drawing interpretation will be done at the initial presentation and at every control visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Changes from Baseline Body Mass Index in Overweight or Obese Children after Physical Activity and Diet Interventions

   Initial measurement of the body mass index (BMI) followed by three additional measurements at 3,6 and 12 months will be performed. These aim to assess the changes from baseline body mass index (BMI) in overweight or obese children, after physical activity and diet interventions.

   Overweight and obesity are defined using age-specific BMI reference guidelines from the 2000 Centers for Disease Control and Prevention Child Growth Charts. Thus, overweight assumes BMI values between the 85th and 95th percentiles, and obesity implies values above the 95th percentile.

   Measured: 0,3,6 and 12 months

2. Changes from Baseline Systolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions

   Initial evaluation of systolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline systolic blood pressure in overweight or obese children, after physical activity and diet interventions.

   Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.

   Measured: 0,3,6 and 12 months

3. Changes from Baseline Diastolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions

   Initial evaluation of diastolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline diastolic blood pressure in overweight or obese children after physical activity and diet interventions.

   Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.

   Measured: 0,3,6 and 12 months

4. Evaluation of Changes in Health-Related Quality of Life in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Pediatric Quality of Life Inventory (PedsQL)

   The questionnaire has 23 items and undertakes the four types of functioning: physical, emotional, social, and educational. It can be filled in by children as well as parents. Higher scores indicate better health-related quality of life.

   PedsQL will be used at the child's first assessment and reapplied at each control visit.

   Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life:

   0 ("Never") = 100

   1. ("Almost Never") = 75
   2. ("Sometimes") = 50
   3. ("Often") = 25
   4. ("Almost Always") = 0 Scale scores are computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of items or more are missing, the Scale Score should not be computed.

   Measured: 0,6 and 12 months

5. Evaluation of Changes in Individual Self-Esteem in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Rosenberg self-esteem scale

   This scale is composed of 10 questions and measures positive and negative feelings about the self. The answer range is from strongly agree to strongly disagree.

   The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.

   Measured: 0,6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Jun 2023
2. Study start10 Jul 2023 (estimated)
3. Primary completion10 Dec 2023 (estimated)
4. Study completion10 Jul 2024 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pediatric 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.