Intensive lifestyle modification program on weight loss and metabolic syndrome risks among obese women in rural areas: a randomized control trial

Not Applicable

Completed

• Conditions: Obesity is a global public health problem [1â€2]. In Thailand, the prevalence of obesity has been increasing at an alarming rate in all life stages [3]. The highest obesity rate is reported to occur; obesity, metabolic syndrome, weight loss, lifestyle modification, women, health role model, rural areas, health belief model&#44

• Registration Number: TCTR20160419002
• Lead Sponsor: Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-07-06
• Study Start: 2016-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria included age 30 to 50 years with a normal menstrual period, body mass index (BMI) ≥27.5 kg/m2, no chronic diseases, no drug use, no pregnancy, no breastfeeding, and no other weight loss program participation. From these eligible participants, 60 were randomly drawn and all agreed to join the program. Then, they were randomly assigned to either the intervention or the control group (1:1). A sample size calculation using the G*Power 3.1.7 statistical program indicated that a minimum of 25 participants were required using average triglyceride content data from previous studies with two independent groups, alpha () 0.05, power (1-β) 0.9, and effect size 0.94 [16]. There were 30 participants in each group to allow for 20% of the expected drop-out rate.

Exclusion Criteria

Exclusion criteria included age: <30 years old or >50 years old; BMI: <27.5 kg/m2; taking a medicine: antihypertensive, lipid lowering, psychiatric, steroid, and weight loss drugs or drugs involving metabolism; having underlying diseases: DM with taking hypoglycemic drugs , HT with taking antihypertensive drugs, thyroidism, coronary heart disease, psychiatric disorder, renal disease, cirrhosis; getting pregnancy or having pregnancy plan in the next 6 months; being in 6 months lactation period; participating in other weight loss programs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvements of body weight and metabolic syndrome component 16 weeks Body weights, BS, TG, HDL-C

Secondary Outcome Measures

Name	Time	Method
Improvements of Anthropometric indicas and KAP 16 weeks Anthropometric and dietary measurements, KAP questionaires