Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2020-05-17
2024-12-30
Brief Summary
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Detailed Description
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Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment. However, it is not easy to make patients change their unhealthy lifestyle. Behavior therapy may only be successful in motivated patients, and motivation to dieting and exercising may be different according to age and sex. Personal motivation for change plays a pivotal role in behavior changes. The transtheoretical model (TTM) is an empirically validated model of individual behavioral change, which involves progress through a series of stages to make a particular behavioral change. TTM-based interventions have been applied to facilitate health behavioral changes, such as physical exercise, smoking cessation, and weight management, studies of which continue to demonstrate positive effects. Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle.
Thus, a total of seventy obese patients with NAFLD will be recruited in this study, divided into lifestyle modification program group(n=35) and usual care group(n=35). All subjects will undergo dietary assessment based on Food Frequency Questionnaire ( FFQ) and motivational stages evaluation based on TTM. Stool samples will be collected at each visit. Demographic data will be recorded, consisted of age, weight, height, waist circumference, BMI, and so on. MRI-PDFF will be performed to evaluate liver steatosis. Meanwhile, vibration-controlled transient elastography will be carried out, which include liver stiffness (LSM) and controlled attenuation parameter (CAP) measurements. Biochemistry tests will be conducted as supplementary for assessment of NAFLD and cardiovascular risks, comprising liver function test, lipid, fasting glucose, etc.
The investigators aim at ①evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); ②investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietitian led life style modification intervention.
Lifestyle changes supervised by dietitians
Dietitian led life style modification intervention
All participants received recommendations for a low-fat hypocaloric diet that was 750 kcal/day less than their daily energy need which supervised by dietitians. Additionally, patients were encouraged to walk 200 minutes per weeks and a short self-report questionnaire for the measurement of habitual physical activity was implemented at baseline, 4, 16, 32 and 48 weeks.
Conventional care (control)
Receive routine care
Conventional care (control)
Receive routine care
Interventions
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Dietitian led life style modification intervention
All participants received recommendations for a low-fat hypocaloric diet that was 750 kcal/day less than their daily energy need which supervised by dietitians. Additionally, patients were encouraged to walk 200 minutes per weeks and a short self-report questionnaire for the measurement of habitual physical activity was implemented at baseline, 4, 16, 32 and 48 weeks.
Conventional care (control)
Receive routine care
Eligibility Criteria
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Inclusion Criteria
2. BMI ≥ 28kg/m2
3. Fatty infiltration of the liver was confirmed on imaging studies (ultrasound, transient elastography, computed tomography, or magnetic resonance imaging) or liver biopsy.
4. With valid motivational stage assessment based on TTM.
5. Written consent form obtained.
Exclusion Criteria
2. Self-reported HIV-positive status, active tuberculosis, active malaria, or inflammatory bowel disease.
3. Excessive alcohol consumption (\>30g/d for men and \>20g/d for women).
4. Patient has known cirrhosis (compensated/decompensated) either based on clinical criteria or liver histology or Imaging techniques.
5. Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and other medicine known to affect liver fat accumulation.
6. Subjects using thiazolidinedione hypoglycemic drugs, vitamin E and other medicine have potential benefits for NASH within six months.
7. Subjects with organ failure.
8. Subjects with hepatocellular carcinoma or other active malignancy.
9. Solid organ transplant recipients.
10. Antibiotic treatment within the previous 3 months.
11. Suffering from any acute or chronic cardiovascular, GI or immunological condition.
12. Gastric or duodenal ulcer in the past six months.
13. Currently pregnant or nursing.
14. Concomitant diseases with reduced life expectancy.
15. Combined mental illness.
16. Contraindication to MRI scanning.
17. Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
18. Inability to provide informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2019-254
Identifier Type: -
Identifier Source: org_study_id
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