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

NCT06261229 | Enrolling By Invitation DMC

• 1 other identifier: MURA2022/230
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Weight Loss; Behavioral Economic; Obese; HOMA-IR

Keywords

Intermittent Fasting; behavioral economic; Obese patients; Weight control; HOMA-IR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• FBS (mg/dl)

  Change from Baseline FBS (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

• Creatinine (mg/dL)

  Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months

• Alanine transaminase (ALT) U/L

  Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months

Study Arms (3)

Intermittent fasting

EXPERIMENTAL

The participant will consume food about/ within 8 hours per day

Behavioral: Intermittent fasting

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.

Behavioral: Intermittent fasting + Behavioral economic

Intensive Lifestyle Modification

EXPERIMENTAL

Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise

Behavioral: Intensive Lifestyle Modification

Interventions

Intermittent fasting BEHAVIORAL

The participant will consume food about/ within 8-hour per day

Intermittent fasting

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

Also known as: Intermittent fasting + Incentives

Intermittent fasting + Behavioral economic

Intensive Lifestyle Modification BEHAVIORAL

Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise

Intensive Lifestyle Modification

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Health Systems Research Institute,Thailand: collaborator

Study Sites (1)

Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Intermittent Fasting; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: February 15, 2024
• Study Start: April 18, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)