Lifestyle Intervention in Obese Arab Women

This study has been completed.

Sponsor:

Collaborators:

D-CURE, Israel.

Chief Scientist, The Israel Ministry of Science

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00273572

First received: January 5, 2006

Last updated: October 27, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2006

Last Updated Date

October 27, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Parameters of the metabolic syndrome and quality of life

Change History

Complete list of historical versions of study NCT00273572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lifestyle Intervention in Obese Arab Women

Official Title ^ICMJE

The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Metabolic Syndrome
Diabetes

Intervention ^ICMJE

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

Other Name: Lifestyle intervention
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

Other Name: Lifestyle intervention

Study Arm (s)

Active Comparator: 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.

Intervention: Other: Moderate Lifestyle Intervention
Experimental: 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.

Intervention: Other: Intensive lifestyle intervention

Publications *

Kalter-Leibovici O, Younis-Zeidan N, Atamna A, Lubin F, Alpert G, Chetrit A, Novikov I, Daoud N, Freedman LS. Lifestyle intervention in obese Arab women: a randomized controlled trial. Arch Intern Med. 2010 Jun 14;170(11):970-6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Diabetic

A contraindication for physical activity

Gender

Female

Ages

35 Years to 54 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00273572

Other Study ID Numbers ^ICMJE

SHEBA-04-3335-OK-CTIL

Has Data Monitoring Committee

Responsible Party

Ofra Kalter, Sheba Medical Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

D-CURE, Israel.
Chief Scientist, The Israel Ministry of Science

Investigators ^ICMJE

Principal Investigator:

Ofra Kalter - Leibovici, M.D.

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

Information Provided By

Sheba Medical Center

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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