Daily Step CountNCT06334666
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD.
A study testing Encourage using pedometer in people with Daily Step Count and MASLD, run by Mahidol University at 1 site in Thailand.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Daily Step Count, MASLD, BMI
- What is being tested?
- Encourage using pedometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be diagnosed with MASLD according to the diagnostic criteria of the A multi-society Delphi consensus statement on new fatty liver disease nomenclature 2023, with evidence of hepatic steatosis and alcohol consumption of less than 140 grams per week for females or less than 210 grams per week for males, along with at least one of the clinical characteristics of metabolic syndrome.
- Participants must be at least 18 years old at the time of enrollment.
- Patients must consent to blood testing for the identification of the patatin like phospholipase domain containing-3 gene polymorphism.
Who cannot join
- Individuals who engage in regular exercise for at least 20 minutes per day, at least 3 days per week.
- Individuals who have regular physical activity with walking exceeding 3000 steps per day before participating in the study.
- Individuals diagnosed with other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, liver cirrhosis, or others.
- Individuals diagnosed with diseases that may affect non-alcoholic fatty liver disease, such as HIV, various chronic inflammatory diseases, or connective tissue disorders.
- Individuals taking medications known to promote fatty liver disease, including amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
- Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, Glucagon-like peptide-1 agonists, SGLT2 inhibitors.
Show all 13Show fewer
- Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
- Individuals with cirrhosis.
- Individuals diagnosed with liver cancer.
- Individuals with severe chronic diseases still exhibiting symptoms during physical activity that may exacerbate the disease, such as coronary artery disease, chronic obstructive pulmonary disease, or severe osteoarthritis.
- Patients with contraindications for undergoing MRI examinations, such as claustrophobia or having body implants or materials that are incompatible with MRI scanning.
- Women who are pregnant.
- Individuals who do not provide formal consent to participate in the research project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease: a Randomized-controlled Trial
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.
Read the detailed description
The results of the health survey of the Thai population through physical examinations in the year 2022 found that among Thai people aged 18 and older, the prevalence of obesity (BMI ≥25 kg/m2) was 44.9% (40.3% in males and 49.2% in females), which has increased significantly over the past decades. This condition is a significant factor contributing to the rising incidence of nonalcoholic fatty liver disease (NAFLD) among the Thai population. NAFLD refers to fatty liver disease in individuals who consume alcohol in amounts less than 140 grams per week for females or less than 210 grams per week for males. Those with clinical features of metabolic dysfunction have been newly defined as having metabolic-associated steatotic liver disease (MASLD).
In this survey of 18,588 individuals, the prevalence of NAFLD was 19.7%, with rates of 20.9% in males and 18.6% in females. It was notably higher at 43.5% in individuals with abdominal obesity (metabolic syndrome) and 35.6% in individuals with diabetes. Factors such as age, sex, physical activity, smoking, and metabolic characteristics such as overweight or obesity, abdominal obesity, high triglyceride levels, diabetes, hypertension, and low HDL cholesterol levels are significantly associated with NAFLD.
MASLD, a type of fatty liver disease, is directly associated with insulin resistance, a key risk factor for cardiovascular diseases. Current treatment guidelines for MASLD have clear evidence that weight loss through dietary control and appropriate physical activity or exercise can reduce fat accumulation in the liver, inflammation, and fibrosis. Importantly, it also improves various metabolic parameters such as blood sugar and lipid levels, as well as the effectiveness of insulin.
The etiology of MASLD is related to behavioral and environmental factors, such as high-calorie diets combined with low physical activity and sedentary lifestyles. These factors promote insulin resistance, stimulating lipolysis and the movement of free fatty acids to various organs, including the liver. This leads to fat accumulation in the liver, insulin-resistant hepatic tissue, abnormal β-oxidation processes, oxidative stress, hepatic inflammation, increased stellate cell activation, and subsequent fibrosis, eventually increasing the risk of liver cirrhosis and hepatocellular carcinoma.
Genetic polymorphisms play a significant role in MASLD pathogenesis, with single nucleotide polymorphisms (SNPs) in the patatin like phospholipase domain containing-3 gene, particularly the rs738409 variant, being strongly associated with fat accumulation and fibrosis in the liver.
Furthermore, a systematic review and analysis of data from 12 studies involving 111,309 individuals found that the number of steps per day, particularly 8,800 steps per day, was associated with a significant reduction in the risk of overall mortality and cardiovascular diseases (CVD). Additionally, increasing physical activity was associated with a reduced risk of chronic liver disease overall and NAFLD specifically. Increasing physical activity by 2,500 steps per day was associated with a 38% reduction in chronic liver disease and a 47% reduction in NAFLD, regardless of obesity status.
This research aims to conduct a randomized study to provide advice to MASLD patients to modify their diet and wear pedometers to encourage changes in physical activity, with a goal of achieving at least 8,800 steps per day, compared to MASLD patients who only receive dietary advice and wear pedometers to record daily steps over a 24-week period.
- Conditions
- Daily Step Count, MASLD, BMI, Metabolic Syndrome, NAFLD, Insulin Resistance
- Being tested
- Encourage using pedometer
- Keywords
- Daily step count, MASLD, Pedometer, BMI, Metabolic Syndrome, NAFLD, Insulin Resistance, Genetic polymorphism, Cardiovascular disease (CVD)
- Medical subject headings
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Insulin Resistance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encourage using pedometerOther
MASLD patient used pedometer recording actively with encourage by care provider or investigator
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Encourage using pedometer group. | Experimental | MASLD patient who received pedometer recording and was encouraged to use actively. Receives: Other: Encourage using pedometer |
| Placebo comparator: Discourage using pedometer group | No intervention | MASLD patient who received pedometer recording but without encouraged to use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To compare the changes in hepatic fat accumulation assessed by magnetic resonance imaging proton-density fat fraction (MRI-PDFF) between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
Measured: 24 weeks
Secondary outcomes (2)
To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
To compare changes in various metabolic parameters(e.g. weight in kilograms, height in meters, blood sugar levels such as FBS in milligrams per deciliter or HbA1C in percentage , and blood lipid profiles such as total cholesteral in milligrams per deciliter) between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
Measured: 24 weeks
To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior.
To study the impact of the patatin like phospholipase domain containing-3 rs738409 G alleles on changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Aug 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Daily Step CountStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phunchai Charatcharoenwitthaya, Mahidol University
- Investigators
- Division of Gastroenterology, Siriraj Hospital, Principal investigator, Siriraj HospitalPhunchai Charatcharoenwitthaya, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334666
- Sponsor's protocol ID
- SI 172/2024
- Status last verified
- May 2025
- First submitted
- 18 Mar 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365Ekstedt M, Nasr P, Kechagias S. Natural History of NAFLD/NASH. Curr Hepatol Rep. 2017;16(4):391-397. doi: 10.1007/s11901-017-0378-2. Epub 2017 Nov 13.
PubMed 29984130Engin A. The Definition and Prevalence of Obesity and Metabolic Syndrome. Adv Exp Med Biol. 2017;960:1-17. doi: 10.1007/978-3-319-48382-5_1.
PubMed 28585193Goodpaster BH, Katsiaras A, Kelley DE. Enhanced fat oxidation through physical activity is associated with improvements in insulin sensitivity in obesity. Diabetes. 2003 Sep;52(9):2191-7. doi: 10.2337/diabetes.52.9.2191.
PubMed 12941756Jeon CY, Lokken RP, Hu FB, van Dam RM. Physical activity of moderate intensity and risk of type 2 diabetes: a systematic review. Diabetes Care. 2007 Mar;30(3):744-52. doi: 10.2337/dc06-1842.
PubMed 17327354White T, Westgate K, Wareham NJ, Brage S. Estimation of Physical Activity Energy Expenditure during Free-Living from Wrist Accelerometry in UK Adults. PLoS One. 2016 Dec 9;11(12):e0167472. doi: 10.1371/journal.pone.0167472. eCollection 2016.
PubMed 27936024LaMonte MJ, Lewis CE, Buchner DM, Evenson KR, Rillamas-Sun E, Di C, Lee IM, Bellettiere J, Stefanick ML, Eaton CB, Howard BV, Bird C, LaCroix AZ. Both Light Intensity and Moderate-to-Vigorous Physical Activity Measured by Accelerometry Are Favorably Associated With Cardiometabolic Risk Factors in Older Women: The Objective Physical Activity and Cardiovascular Health (OPACH) Study. J Am Heart Assoc. 2017 Oct 17;6(10):e007064. doi: 10.1161/JAHA.117.007064.
PubMed 29042429Kim D, Murag S, Cholankeril G, Cheung A, Harrison SA, Younossi ZM, Ahmed A. Physical Activity, Measured Objectively, Is Associated With Lower Mortality in Patients With Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1240-1247.e5. doi: 10.1016/j.cgh.2020.07.023. Epub 2020 Jul 16.
PubMed 32683103Saint-Maurice PF, Troiano RP, Berrigan D, Kraus WE, Matthews CE. Volume of Light Versus Moderate-to-Vigorous Physical Activity: Similar Benefits for All-Cause Mortality? J Am Heart Assoc. 2018 Apr 2;7(7):e008815. doi: 10.1161/JAHA.118.008815.
PubMed 29610219Bird SR, Hawley JA. Update on the effects of physical activity on insulin sensitivity in humans. BMJ Open Sport Exerc Med. 2017 Mar 1;2(1):e000143. doi: 10.1136/bmjsem-2016-000143. eCollection 2016.
PubMed 28879026Kwak MS, Kim D, Chung GE, Kim W, Kim JS. The preventive effect of sustained physical activity on incident nonalcoholic fatty liver disease. Liver Int. 2017 Jun;37(6):919-926. doi: 10.1111/liv.13332. Epub 2016 Dec 24.
PubMed 27917585Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.
PubMed 21206486Asada F, Nomura T, Hosui A, Kubota M. Influence of increased physical activity without body weight loss on hepatic inflammation in patients with nonalcoholic fatty liver disease. Environ Health Prev Med. 2020 Jun 10;25(1):18. doi: 10.1186/s12199-020-00857-6.
PubMed 32522147Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.
PubMed 28039099Stine JG, Munaganuru N, Barnard A, Wang JL, Kaulback K, Argo CK, Singh S, Fowler KJ, Sirlin CB, Loomba R. Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2274-2283.e5. doi: 10.1016/j.cgh.2020.08.061. Epub 2020 Aug 31.
PubMed 32882428
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06334666
- Acronym / sponsor ID
- SI 172/2024
- Conditions
- Daily Step Count, MASLD, BMI, Metabolic Syndrome, NAFLD, Insulin Resistance
- Keywords
- Daily step count, MASLD, Pedometer, BMI, Metabolic Syndrome, NAFLD, Insulin Resistance, Genetic polymorphism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The results of the health survey of the Thai population through physical examinations in the year 2022 found that among Thai people aged 18 and older, the prevalence of obesity (BMI ≥25 kg/m2) was 44.9% (40.3% in males and 49.2% in females), which has increased significantly over the past decades. This condition is a significant factor contributing to the rising incidence of nonalcoholic fatty liver disease (NAFLD) among the Thai population. NAFLD refers to fatty liver disease in individuals who consume alcohol in amounts less than 140 grams per week for females or less than 210 grams per week for males. Those with clinical features of metabolic dysfunction have been newly defined as having metabolic-associated steatotic liver disease (MASLD).
In this survey of 18,588 individuals, the prevalence of NAFLD was 19.7%, with rates of 20.9% in males and 18.6% in females. It was notably higher at 43.5% in individuals with abdominal obesity (metabolic syndrome) and 35.6% in individuals with diabetes. Factors such as age, sex, physical activity, smoking, and metabolic characteristics such as overweight or obesity, abdominal obesity, high triglyceride levels, diabetes, hypertension, and low HDL cholesterol levels are significantly associated with NAFLD.
MASLD, a type of fatty liver disease, is directly associated with insulin resistance, a key risk factor for cardiovascular diseases. Current treatment guidelines for MASLD have clear evidence that weight loss through dietary control and appropriate physical activity or exercise can reduce fat accumulation in the liver, inflammation, and fibrosis. Importantly, it also improves various metabolic parameters such as blood sugar and lipid levels, as well as the effectiveness of insulin.
The etiology of MASLD is related to behavioral and environmental factors, such as high-calorie diets combined with low physical activity and sedentary lifestyles. These factors promote insulin resistance, stimulating lipolysis and the movement of free fatty acids to various organs, including the liver. This leads to fat accumulation in the liver, insulin-resistant hepatic tissue, abnormal β-oxidation processes, oxidative stress, hepatic inflammation, increased stellate cell activation, and subsequent fibrosis, eventually increasing the risk of liver cirrhosis and hepatocellular carcinoma.
Genetic polymorphisms play a significant role in MASLD pathogenesis, with single nucleotide polymorphisms (SNPs) in the patatin like phospholipase domain containing-3 gene, particularly the rs738409 variant, being strongly associated with fat accumulation and fibrosis in the liver.
Furthermore, a systematic review and analysis of data from 12 studies involving 111,309 individuals found that the number of steps per day, particularly 8,800 steps per day, was associated with a significant reduction in the risk of overall mortality and cardiovascular diseases (CVD). Additionally, increasing physical activity was associated with a reduced risk of chronic liver disease overall and NAFLD specifically. Increasing physical activity by 2,500 steps per day was associated with a 38% reduction in chronic liver disease and a 47% reduction in NAFLD, regardless of obesity status.
This research aims to conduct a randomized study to provide advice to MASLD patients to modify their diet and wear pedometers to encourage changes in physical activity, with a goal of achieving at least 8,800 steps per day, compared to MASLD patients who only receive dietary advice and wear pedometers to record daily steps over a 24-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Encourage using pedometer group. | Experimental | Other: Encourage using pedometerMASLD patient who received pedometer recording and was encouraged to use actively. |
| Placebo comparator: Discourage using pedometer group | No intervention | –MASLD patient who received pedometer recording but without encouraged to use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be diagnosed with MASLD according to the diagnostic criteria of the A multi-society Delphi consensus statement on new fatty liver disease nomenclature 2023, with evidence of hepatic steatosis and alcohol consumption of less than 140 grams per week for females or less than 210 grams per week for males, along with at least one of the clinical characteristics of metabolic syndrome.
- Participants must be at least 18 years old at the time of enrollment.
- Patients must consent to blood testing for the identification of the patatin like phospholipase domain containing-3 gene polymorphism.
Key exclusion criteria (13 listed)
- Individuals who engage in regular exercise for at least 20 minutes per day, at least 3 days per week.
- Individuals who have regular physical activity with walking exceeding 3000 steps per day before participating in the study.
- Individuals diagnosed with other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, liver cirrhosis, or others.
- Individuals diagnosed with diseases that may affect non-alcoholic fatty liver disease, such as HIV, various chronic inflammatory diseases, or connective tissue disorders.
- Individuals taking medications known to promote fatty liver disease, including amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encourage using pedometerMASLD patient used pedometer recording actively with encourage by care provider or investigator | Other | Active Comparator: Encourage using pedometer group. |
Primary outcome
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
To compare the changes in hepatic fat accumulation assessed by magnetic resonance imaging proton-density fat fraction (MRI-PDFF) between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
2 secondary outcomes
To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
Time frame: 24 weeks
To study the impact of genes on changes in hepatic fat accumulation 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Results publication: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Results publication: PubMed 29984130Ekstedt M, Nasr P, Kechagias S. Natural History of NAFLD/NASH. Curr Hepatol Rep. 2017;16(4):391-397. doi: 10.1007/s11901-017-0378-2. Epub 2017 Nov 13.
- Results publication: PubMed 28585193Engin A. The Definition and Prevalence of Obesity and Metabolic Syndrome. Adv Exp Med Biol. 2017;960:1-17. doi: 10.1007/978-3-319-48382-5_1.
- Results publication: PubMed 12941756Goodpaster BH, Katsiaras A, Kelley DE. Enhanced fat oxidation through physical activity is associated with improvements in insulin sensitivity in obesity. Diabetes. 2003 Sep;52(9):2191-7. doi: 10.2337/diabetes.52.9.2191.
- Results publication: PubMed 17327354Jeon CY, Lokken RP, Hu FB, van Dam RM. Physical activity of moderate intensity and risk of type 2 diabetes: a systematic review. Diabetes Care. 2007 Mar;30(3):744-52. doi: 10.2337/dc06-1842.
- Results publication: PubMed 27936024White T, Westgate K, Wareham NJ, Brage S. Estimation of Physical Activity Energy Expenditure during Free-Living from Wrist Accelerometry in UK Adults. PLoS One. 2016 Dec 9;11(12):e0167472. doi: 10.1371/journal.pone.0167472. eCollection 2016.
- Results publication: PubMed 29042429LaMonte MJ, Lewis CE, Buchner DM, Evenson KR, Rillamas-Sun E, Di C, Lee IM, Bellettiere J, Stefanick ML, Eaton CB, Howard BV, Bird C, LaCroix AZ. Both Light Intensity and Moderate-to-Vigorous Physical Activity Measured by Accelerometry Are Favorably Associated With Cardiometabolic Risk Factors in Older Women: The Objective Physical Activity and Cardiovascular Health (OPACH) Study. J Am Heart Assoc. 2017 Oct 17;6(10):e007064. doi: 10.1161/JAHA.117.007064.
- Results publication: PubMed 32683103Kim D, Murag S, Cholankeril G, Cheung A, Harrison SA, Younossi ZM, Ahmed A. Physical Activity, Measured Objectively, Is Associated With Lower Mortality in Patients With Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1240-1247.e5. doi: 10.1016/j.cgh.2020.07.023. Epub 2020 Jul 16.
- Results publication: PubMed 29610219Saint-Maurice PF, Troiano RP, Berrigan D, Kraus WE, Matthews CE. Volume of Light Versus Moderate-to-Vigorous Physical Activity: Similar Benefits for All-Cause Mortality? J Am Heart Assoc. 2018 Apr 2;7(7):e008815. doi: 10.1161/JAHA.118.008815.
- Results publication: PubMed 28879026Bird SR, Hawley JA. Update on the effects of physical activity on insulin sensitivity in humans. BMJ Open Sport Exerc Med. 2017 Mar 1;2(1):e000143. doi: 10.1136/bmjsem-2016-000143. eCollection 2016.
- Results publication: PubMed 27917585Kwak MS, Kim D, Chung GE, Kim W, Kim JS. The preventive effect of sustained physical activity on incident nonalcoholic fatty liver disease. Liver Int. 2017 Jun;37(6):919-926. doi: 10.1111/liv.13332. Epub 2016 Dec 24.
- Results publication: PubMed 21206486Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Gastroenterology, Siriraj Hospital principal investigator
Siriraj Hospital
Phunchai Charatcharoenwitthaya, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encourage using pedometer in people with Daily Step Count and MASLD, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334666, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.