The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- HOMR-IR (index)
研究概览
简要总结
This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.
Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.
The study protocol will be explained to the eligible participant and informed written consent will be obtained.
The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.
详细描述
The investigators will collect the participant characteristics (age, gender, smoking history, comorbid diseases including history of previous stroke, myocardial infarction, angina, hypertension, dyslipidemia, T2DM, risk of osteoporosis, and all medication lists) at the first visit.
- Physiological parameters:
- Body composition will be assessed by the Bioelectrical Impedance at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Peripheral venous blood sample (15mL: clotted blood 9mL and EDTA blood 6 mL) and urinalysis will be collected from all participants at baseline and each follow-up visit (1-month, 2-months, 6-month, and 12 months). Blood samples will be immediately centrifuged and plasma/serum will be placed in a -80 Celsius freezer until analysis (glucose, HbA1C, insulin, albumin, creatinine, uric acid, lipid profile, liver function test, kidney function test, thyroid function test, and other biochemical).
- Three questionnaires will be collected:
1) Global physical activity questionnaire, sleep questionnaire, and satiety visual analog score questionnaire will be obtained at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
- Nutritional status will be assessed by history, 24-hour dietary recall, 3days food record, and physical examinations at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months).
Regarding the descriptive statistical analysis, all the data will be tested for normality. Data will be presented as Mean ± standard deviation or Median (interquartile ranges) for continuous variables and frequency (%) for binary and categorical variables. The continuous variables will be compared by using Independent samples T-test or Analysis of variance (ANOVA) followed by multiple comparisons with the Bonferroni method. Test results of categorical variables will be evaluated by Chi-square or Fisher exact test as appropriate. Results will be deemed statistically significant at a P-value < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 year
- •BMI start at 25.0 kg/m2 (above 24.99 kg/m2)
- •Weight change less than 5% in 6-month
- •Ability and willingness to provide informed consent
排除标准
- •Pregnant women or breed feeding
- •Kidney disease/ Liver disease
- •Abnormal Thyroid hormone, abnormal GI function
- •Postoperative bariatric surgery
- •Drug control weight or reduce appetite
- •Drug abuse
- •Mental illness
研究组 & 干预措施
Intermittent fasting
The participant will consume food about/ within 8 hours per day
干预措施: Intermittent fasting (Behavioral)
Intermittent fasting + Behavioral economic
The participant will consume food about/ within 8-hour per day. They will be rewarded as money when they achieve their weight loss goal or/and successfully do intermittent fasting 5 days/week.
干预措施: Intermittent fasting + Behavioral economic (Behavioral)
Intensive Lifestyle Modification
Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise
干预措施: Intensive Lifestyle Modification (Behavioral)
结局指标
主要结局
HOMR-IR (index)
时间窗: Change from Baseline HOMR-IR at 6 months and 12 months
Homeostatic Model Assessment for Insulin Resistance
Body mass index (kg/m^2)
时间窗: Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Body weight and height will be combined to report BMI in kg/m\^2
次要结局
- Alanine transaminase (ALT) U/L(Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months)
- HDL-C (mg/dL)(Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- LDL-C (mg/dL)(Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- Energy from food (kilocalories)(Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months)
- Creatinine (mg/dL)(Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- FBS (mg/dl)(Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months)
- Uric acid (mg/dL)(Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- Urine albumin-creatinine ratio (UACR) (mg/g)(Change from Baseline Urine albumin-creatinine ratio (UACR) (mg/g) at 1 month, 2 months, 6 months, and 12 months)
- Aspartate transaminase (AST) U/L(Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months)
- Triglycerides (mg/dL)(Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- Blood Urea Nitrogen (BUN) (mg/dL)(Change from Baseline Blood Urea Nitrogen (BUN) (mg/dL) at 1 month, 2 months, 6 months, and 12 months)
- HbA1C (%)(Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months)
- Albumin (g/L)(Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months)
- Total cholesterol (mg/dL)(Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months)