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Clinical Trials/TCTR20160419002
TCTR20160419002
Completed
未知

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

Mahidol University0 sites60 target enrollmentApril 19, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Obesity is a global public health problem [1â€2]. In Thailand&#44
Sponsor
Mahidol University
Enrollment
60
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 19, 2016
End Date
July 6, 2014
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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