Lifestyle Intervention in Obese Arab Women - Full Text View

Sponsors and Collaborators:	Sheba Medical Center D-CURE, Israel. Chief Scientist, The Israel Ministry of Science
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00273572

Purpose

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

Condition	Intervention
Metabolic Syndrome Diabetes	Other: Moderate Lifestyle Intervention Other: Intensive lifestyle intervention

MedlinePlus related topics: Obesity

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Parameters of the metabolic syndrome [ Time Frame: At baseline, and after 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: At baseline, and after 12 months ] [ Designated as safety issue: No ]
Attainment of weight reduction and physical activity targets [ Time Frame: At baseline, and after 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	December 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Moderate lifestyle intervention: Active Comparator 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.	Other: Moderate Lifestyle Intervention Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
Intensive lifestyle intervention: Experimental 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.	Other: Intensive lifestyle intervention A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor

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.

Eligibility

Ages Eligible for Study:	35 Years to 54 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Diabetic

A contraindication for physical activity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273572

Locations

Israel
Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Tel-Hashomer, Ramat-Gan, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

D-CURE, Israel.

Chief Scientist, The Israel Ministry of Science

Investigators

Principal Investigator:

Ofra Kalter - Leibovici, M.D.

Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL

More Information

Responsible Party:	Sheba Medical Center ( Ofra Kalter )
Study ID Numbers:	SHEBA-04-3335-OK-CTIL
Study First Received:	January 5, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00273572
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Obesity
Women
Arab

Metabolic syndrome
Lifestyle intervention
Quality of life

Study placed in the following topic categories:

Obesity
Diabetes Mellitus
Quality of Life

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009