Lifestyle Intervention in Obese Arab Women

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diabetes
• Interventions: Other: Moderate Lifestyle Intervention; Other: Intensive lifestyle intervention

• Registration Number: NCT00273572
• Lead Sponsor: Sheba Medical Center

Brief Summary

The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women

Detailed Description

200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-27
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Obesity (BMI: 30-40 kg/squared meter)
• Female Gender
• Being 35-54 years old

Exclusion Criteria

• Diabetic

A contraindication for physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate lifestyle intervention	Moderate Lifestyle Intervention	Moderate lifestyle intervention including two group sessions and one individual counselling session with a nutritionist, at recruitment. Individual sessions with a nutritionist after 6 and 12 months on follow-up.
Intensive lifestyle intervention	Intensive lifestyle intervention	Intensive lifestyle intervention, including bi-monthly group sessions with a physical activity instructor; a monthly group session with a nutritionist, and a monthly individual session with a nutritionist.

Primary Outcome Measures

Name	Time	Method
Parameters of the metabolic syndrome	At baseline, and after 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	At baseline, and after 12 months
Attainment of weight reduction and physical activity targets	At baseline, and after 6 and 12 months

Trial Locations

Locations (1)

Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center; 🇮🇱 Tel-Hashomer, Ramat-Gan, Israel