The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients

Not Applicable

• Conditions: Intermittent Fasting; Obese; Weight Loss; HOMA-IR; Behavioral Economic
• Interventions: Behavioral: Intermittent fasting; Behavioral: Intermittent fasting + Behavioral economic; Behavioral: Intensive Lifestyle Modification

• Registration Number: NCT06261229
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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:

1. 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).

2. 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.

Study Timeline

• Study Start: 2022-04-18
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting	Intermittent fasting	The participant will consume food about/ within 8 hours per day
Intermittent fasting + Behavioral economic	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.
Intensive Lifestyle Modification	Intensive Lifestyle Modification	Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise

Primary Outcome Measures

Name	Time	Method
HOMR-IR (index)	Change from Baseline HOMR-IR at 6 months and 12 months	Homeostatic Model Assessment for Insulin Resistance
Body mass index (kg/m^2)	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

Secondary Outcome Measures

Name	Time	Method
Alanine transaminase (ALT) U/L	Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months	ALT is commonly measured clinically as part of liver function tests
HDL-C (mg/dL)	Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months	High-density lipoprotein cholesterol
LDL-C (mg/dL)	Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months	Low-density lipoprotein cholesterol
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	Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record
Creatinine (mg/dL)	Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months	a waste product that comes from the normal wear and tear on muscles of the body
FBS (mg/dl)	Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months	Fasting blood glucose
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	AST is commonly measured clinically as part of liver function tests
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	Average blood sugar levels over the past 3 months
Albumin (g/L)	Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months	a blood plasma protein synthesized in the liver
Total cholesterol (mg/dL)	Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand