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| Name | Class |
|---|---|
| Health Systems Research Institute,Thailand | OTHER_GOV |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent fasting | Experimental | The participant will consume food about/ within 8 hours per day |
|
| Intermittent fasting + Behavioral economic | Experimental | 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. |
|
| Intensive Lifestyle Modification | Experimental | Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent fasting | Behavioral | The participant will consume food about/ within 8-hour per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| HOMR-IR (index) | Homeostatic Model Assessment for Insulin Resistance | Change from Baseline HOMR-IR at 6 months and 12 months |
| Body mass index (kg/m^2) | Body weight and height will be combined to report BMI in kg/m^2 | Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| FBS (mg/dl) | Fasting blood glucose | Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months |
| HbA1C (%) | Average blood sugar levels over the past 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
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| Intermittent fasting + Behavioral economic | Behavioral | The participant will consume food about/ within 8-hour per day. They will be received a reward as money when achieve weight loss goal or/and success doing intermittent fasting 5 days/week |
|
|
| Intensive Lifestyle Modification | Behavioral | Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise |
|
| Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months |
| Albumin (g/L) | a blood plasma protein synthesized in the liver | Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months |
| Creatinine (mg/dL) | a waste product that comes from the normal wear and tear on muscles of the body | Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months |
| Alanine transaminase (ALT) U/L | ALT is commonly measured clinically as part of liver function tests | Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months |
| Aspartate transaminase (AST) U/L | AST is commonly measured clinically as part of liver function tests | Change from Baseline Aspartate transaminase (AST) U/L 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 |
| Total cholesterol (mg/dL) | Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months |
| HDL-C (mg/dL) | High-density lipoprotein cholesterol | Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months |
| LDL-C (mg/dL) | Low-density lipoprotein cholesterol | Change from Baseline LDL-C (mg/dL) 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 |
| 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 |
| Energy from food (kilocalories) | Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record | Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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