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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160419002
Enrollment
Unknown
Registered
2016-04-19
Start date
2014-02-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity is a global public health problem [1–2]. In Thailand&#44

Interventions

The program was designed to highlight the individual’s health concerns and help them recognize their susceptibility to obesity&#44
its co&#45
and its potential life threatening severity. Expectantly&#44
individuals would change their lifestyles when they perceived the benefits of positive lifestyle changes&#44
particularly with regards to diet and physical activity. Additionally&#44
the model aims to provide confidence to overcome any perceived barriers via counseling&#44
and exercise training. The Diabetes Prevention Program&#44
which includes health education and accumulative exercise&#44
was adapted for this study [17]. In addition&#44
motivational interviewing was employed to inspire the participants to adhere to the recommended diet and exercise regime [18–19]. The program was implemented for 16 weeks during the summer to best
once a week for 8 weeks and then every 2 weeks until the 16th week. Each session included 9 to 11 participants and lasted 90 to 120 minutes including 30 to 45 minutes of exercise. Importantly&#44
each session was conducted in the community by an interventionist as a health role model and a trained preparation assistant. The health role model was a nutritionist nurse who had successfully lost w
building between the interventionist and the participants. At the end of each session&#44
participants received a small sample of healthy food that included fresh fruits and low fat milk. All four of the main components of the interven
Experimental Behavioral,Active Comparator Behavioral
Intensive lifestyle modification,Local standard of weight management

Sponsors

Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 50 Years

Inclusion 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: Exclusion criteria included age: 50 years old; BMI: <27.5 kg/m2; taking a medicine: antihypertensive&#44; lipid lowering&#44; psychiatric&#44; steroid&#44; and weight loss drugs or drugs involving metabolism; having underlying diseases: DM with taking hypoglycemic drugs &#44; HT with taking antihypertensive drugs&#44; thyroidism&#44; coronary heart disease&#44; psychiatric disorder&#44; renal disease&#44; cirrhosis; getting pregnancy or having pregnancy plan in the next 6 months; being in 6 months lactation period; participating in other weight loss programs

Design outcomes

Primary

MeasureTime frame
Improvements of body weight and metabolic syndrome component 16 weeks Body weights&#44; BS&#44; TG&#44; HDL&#45;C

Secondary

MeasureTime frame
Improvements of Anthropometric indicas and KAP 16 weeks Anthropometric and dietary measurements&#44; KAP questionaires

Countries

Thailand

Contacts

Public ContactCharunee Thiabpho

Department of Nutrition and Food Sciences&#44; Faculty of Tropical Medicine&#44; Mahidol University

Jenny.thaib@gmail.com0894166163

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026