The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD.

Sponsor
Mahidol University
Study ID
NCT06334666
Status
Enrolling By Invitation

Conditions

  • BMI
  • Cardiovascular Disease (CVD)
  • Daily Step Count
  • Genetic Polymorphism
  • Insulin Resistance
  • MASLD
  • Metabolic Syndrome
  • NAFLD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encourage using pedometer — OTHER
    MASLD patient used pedometer recording actively with encourage by care provider or investigator

Study Details

The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks.

Key Dates

First listed
Mar 28, 2024
Start date
Aug 1, 2024
Status verified
May 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Comparator: Encourage using pedometer group.
    MASLD patient who received pedometer recording and was encouraged to use actively.
  • No Intervention: Placebo comparator: Discourage using pedometer group
    MASLD patient who received pedometer recording but without encouraged to use.

Primary Outcome Measure

To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. [ Time Frame: 24 weeks ]

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