Lifestyle Habits and Metabolic Dysfunction-Associated Steatotic Liver Disease in Youth

NCT07095010 | Completed

• 1 other identifier: 5296
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease in children and adolescents. Lifestyle factors are modifiable risk factors that may play a key role in both the prevention and management of the disease. However, existing data on the association between lifestyle and MASLD in pediatric populations are limited and often focus on isolated aspects such as diet or physical activity, with little attention given to other parameters like sleep habits. The aim of the present study is to comprehensively investigate the association between lifestyle factors, including dietary habits, physical activity, sedentary activities, and sleep habits, and the presence of MASLD in a sample of 224 children and adolescents with overweight or obesity. The study will include newly diagnosed MASLD patients compared to matched controls without the disease. A wide range of assessments will be conducted, including anthropometric measurements, body composition analysis, liver elastography, biochemical testing, and standardized lifestyle questionnaires. This study seeks to fill important research gaps and explore potential associations between lifestyle habits and pathophysiological markers involved in the onset and progression of MASLD.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Childhood Obesity

Outcome Measures

Primary Outcomes (6)

• Differences in dietary intake between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  The dietary intake of the participants will be assessed by four 24-hour recall method and analyzed using the Nutritionist Pro software program.

  Baseline

• Difference in adherence to the Mediterranean diet between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  The adherence to the Mediterranean diet will be evaluated using the KIDMED questionnaire. The index of adherence to the Mediterranean diet was calculated as the sum of each answer and ranged from 0 to 12. The sums of the values of the KIDMED score will be classified into three levels: (1) \>8, optimal Mediterranean diet; (2) 4-7, improvement needed to adjust intake to Mediterranean patterns; (3) ≤3, very low diet quality.

  Baseline

• Differences in physical activity between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  Physical activity will be assessed using the Self-Administered Physical Activity Checklist, a questionnaire validated in the Greek population. This checklist records the type, frequency, and duration of physical activities performed in the previous day. Each participant (or their caregiver) will complete the checklist four times, with the assistance of a registered dietitian, immediately following the 24-hour dietary recall interviews. From the collected data, the average daily time spent in physical activity (in minutes per day) will be calculated. The checklist yields a quantitative score ranging from 0 to an unlimited maximum, depending on the number and duration of activities reported. Higher scores indicate greater levels of physical activity, reflecting more time spent in moderate-to-vigorous physical activity during the assessed day.

  Baseline

• Differences in sedentary activities between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  Sedentary activities will be assessed with the Self-Administered Physical Activity Checklist (SAPAC), a questionnaire validated for the Greek population. Each participant (or caregiver) will complete the checklist four times with support from a registered dietitian immediately after each 24-hour dietary recall. For every administration, the SAPAC records the duration of common sedentary behaviours (e.g., television viewing, videogaming, seated reading). The summed sedentary-time score is expressed in hours per day and has a possible range of 0 h (no sedentary time) to 24 h (continuous sedentary behaviour). Higher scores indicate a worse outcome, namely, more time spent in sedentary activities. The mean of the four administrations will be used as each participant's average daily sedentary time.

  Baseline

• Differences in sleep hours between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  Total night sleep hours will be recorded.

  Baseline

• Differences in daytime sleepiness between children and adolescents with overweight/obesity and MASLD and their matched controls without MASLD.

  The daytime sleepiness will be evaluated using the Pediatric Daytime Sleepiness Scale (score range 0-32). Higher scores indicated greater levels of sleepiness.

  Baseline

Secondary Outcomes (5)

• hs-CRP

  Baseline

• Adiponectin

  Baseline

• Fibroblast Growth Factor 21

  Baseline

• Oxidative stress

  Baseline

• Insulin resistance

  Baseline

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

224 children and adolescents with overweight/ obesity and/or Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

You may qualify if:

• Age: Children and adolescents aged 10 to 18 years, of Caucasian ethnicity, regardless of sex or nationality.
• Overweight or Obesity: Children/adolescents with overweight or obesity according to World Health Organization (WHO) criteria for ages 5-19.
• Newly Diagnosed Metabolic Dysfunction-Associated Steatotic Liver Disease: Diagnosis will be established in participants who meet all of the following criteria:
• Elevated ALT levels (\>45 IU/L), according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, and/or evidence of hepatic steatosis on liver ultrasound.

You may not qualify if:

• Type 1 diabetes mellitus
• Alcohol consumption
• Malnutrition or parenteral nutrition
• Thyroid function
• Recent changes in diet and physical activity habits aimed at weight loss and/or improvement of health parameters in newly diagnosed children and adolescents

Sponsors & Collaborators

• Harokopio University: lead
• Children 's Hospital, Agia Sophia: collaborator

Study Sites (1)

Harokopio University

Athens, Kallithea, 17671, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The following samples will be retained and stored at -80°C: 2 ml of serum, 2 ml of plasma, and 2 ml of urine.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Meropi D Kontogianni

  Harokopio University Athens, Kallithea, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Nutrition

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 31, 2025
• Study Start: January 10, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 20, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

GR (1)