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

Mahidol University

Status: Invitation-only

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

Treatments: Behavioral: Intermittent fasting + Behavioral economic; Behavioral: Intensive Lifestyle Modification; Behavioral: Intermittent fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT06261229

MURA2022/230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

Intermittent fasting

Experimental group

Description:

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

Treatment:

Behavioral: Intermittent fasting

Intermittent fasting + Behavioral economic

Experimental group

Description:

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.

Treatment:

Behavioral: Intermittent fasting + Behavioral economic

Intensive Lifestyle Modification

Experimental group

Description:

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

Treatment:

Behavioral: Intensive Lifestyle Modification