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出境医 / 临床实验 / Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Study Description
Brief Summary:
Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Obesity Behavioral: Lifestyle education Behavioral: Intensive lifestyle intervention Behavioral: Hypocaloric low-carbohydrate diet plan Not Applicable

Detailed Description:
This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Lifestyle education
The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study.
 Behavioral: Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Experimental: Intensive Lifestyle Intervention
The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.
 Behavioral: Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.

Behavioral: Intensive lifestyle intervention
One to one intensive lifestyle intervention according to the diet and activity plan

Behavioral: Hypocaloric low-carbohydrate diet plan
A diet plan with restricted calorie and carbohydrate intake
Outcome Measures
Primary Outcome Measures :
  1. Change in BMI [ Time Frame: baseline, 3 month ]
  2. Change in liver function biomarkers [ Time Frame: baseline, 3 month ]
    ALT, AST

  3. Liver Stiffness Measurement [ Time Frame: baseline, 3 month ]
    LSM is suggested as degree of liver fibrosis

  4. Fast Ultrasound Attenuation Parameter [ Time Frame: baseline, 3 month ]
    FAP is suggested as degree of liver steatosis.


Secondary Outcome Measures :
  1. Change in BMI [ Time Frame: 6 month, 12 month ]
  2. Change in liver function biomarkers [ Time Frame: 6 month, 12 month ]
    ALT, AST

  3. Change in blood pressure [ Time Frame: baseline, 3 month ]
  4. Change in lipid [ Time Frame: baseline, 3 month ]
    triglyceride, total cholesterol , LDL-C, and HDL-C

  5. Change in glycemic markers [ Time Frame: baseline, 3 month ]
    fasting glucose, fasting insulin, HbA1C

  6. Change in body composition [ Time Frame: baseline, 3 month ]
    muscle mass, fat percentage


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or women aged 18-65 years;
  • Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
  • Body mass index (BMI)of 25.0 to 35.0 kg/m2;
  • Patients without medicine for treatment of NAFLD;

Exclusion Criteria:

  • Patients with other diseases that can lead to fatty liver;
  • Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
  • Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
  • Patients with diseases that need control of dietary protein intake;
  • Patients with diseases that affect food digestion and absorption;
  • Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
  • Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
  • Patients with secondary obesity;
  • Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
  • Pregnancy or lactation;
  • Physical disability.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zhong Liu +86 13957104885 liuzhongzheyi121@163.com

Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
Layout table for investigator information
Principal Investigator: Zhong Zhong, MD First Affiliated Hospital of Zhejiang University
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Change in BMI [ Time Frame: baseline, 3 month ]
  • Change in liver function biomarkers [ Time Frame: baseline, 3 month ]
    ALT, AST
  • Liver Stiffness Measurement [ Time Frame: baseline, 3 month ]
    LSM is suggested as degree of liver fibrosis
  • Fast Ultrasound Attenuation Parameter [ Time Frame: baseline, 3 month ]
    FAP is suggested as degree of liver steatosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Change in BMI [ Time Frame: 6 month, 12 month ]
  • Change in liver function biomarkers [ Time Frame: 6 month, 12 month ]
    ALT, AST
  • Change in blood pressure [ Time Frame: baseline, 3 month ]
  • Change in lipid [ Time Frame: baseline, 3 month ]
    triglyceride, total cholesterol , LDL-C, and HDL-C
  • Change in glycemic markers [ Time Frame: baseline, 3 month ]
    fasting glucose, fasting insulin, HbA1C
  • Change in body composition [ Time Frame: baseline, 3 month ]
    muscle mass, fat percentage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
Official Title  ICMJE Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
Brief Summary Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.
Detailed Description This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Obesity
Intervention  ICMJE
  • Behavioral: Lifestyle education
    Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
  • Behavioral: Intensive lifestyle intervention
    One to one intensive lifestyle intervention according to the diet and activity plan
  • Behavioral: Hypocaloric low-carbohydrate diet plan
    A diet plan with restricted calorie and carbohydrate intake
Study Arms  ICMJE
  • Placebo Comparator: Lifestyle education
    The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study.
    Intervention: Behavioral: Lifestyle education
  • Experimental: Intensive Lifestyle Intervention
    The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.
    Interventions:
    • Behavioral: Lifestyle education
    • Behavioral: Intensive lifestyle intervention
    • Behavioral: Hypocaloric low-carbohydrate diet plan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		292
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Man or women aged 18-65 years;
  • Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
  • Body mass index (BMI)of 25.0 to 35.0 kg/m2;
  • Patients without medicine for treatment of NAFLD;

Exclusion Criteria:

  • Patients with other diseases that can lead to fatty liver;
  • Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
  • Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
  • Patients with diseases that need control of dietary protein intake;
  • Patients with diseases that affect food digestion and absorption;
  • Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
  • Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
  • Patients with secondary obesity;
  • Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
  • Pregnancy or lactation;
  • Physical disability.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhong Liu +86 13957104885 liuzhongzheyi121@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972631
Other Study ID Numbers  ICMJE CHPF2018-NALFD-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Liu Zhong, First Affiliated Hospital of Zhejiang University
Study Sponsor  ICMJE First Affiliated Hospital of Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhong Zhong, MD First Affiliated Hospital of Zhejiang University
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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