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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Weight Loss; Obese; Intermittent Fasting; Behavioral Economic; HOMA-IR
• Intervention / Treatment: Behavioral: Intermittent fasting; Behavioral: Intermittent fasting + Behavioral economic; Behavioral: Intensive Lifestyle Modification

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 Type: Interventional
• Enrollment (Estimated): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent fasting; The participant will consume food about/ within 8 hours per day	Behavioral: Intermittent fasting; The participant will consume food about/ within 8-hour per day
Experimental: 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.	Behavioral: Intermittent fasting + Behavioral economic; 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; Other Names: Intermittent fasting + Incentives
Experimental: Intensive Lifestyle Modification; Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise	Behavioral: Intensive Lifestyle Modification; Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Health Systems Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Intermittent Fasting; HOMA-IR; Weight control; Obese patients; behavioral economic
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: MURA2022/230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No