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Lifestyle Intervention in Obese Arab Women

Primary Purpose

Metabolic Syndrome, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Moderate Lifestyle Intervention
Intensive lifestyle intervention
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Obesity, Women, Arab, Metabolic syndrome, Lifestyle intervention, Quality of life

Eligibility Criteria

35 Years - 54 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Obesity (BMI: 30-40 kg/squared meter) Female Gender Being 35-54 years old Exclusion Criteria: Diabetic A contraindication for physical activity

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate lifestyle intervention

Intensive lifestyle intervention

Arm Description

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, 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.

Outcomes

Primary Outcome Measures

Parameters of the metabolic syndrome

Secondary Outcome Measures

Quality of life
Attainment of weight reduction and physical activity targets

Full Information

First Posted
January 5, 2006
Last Updated
October 27, 2008
Sponsor
Sheba Medical Center
Collaborators
D-Cure, Israel, Chief Scientist, The Israel Ministry of Science
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1. Study Identification

Unique Protocol Identification Number
NCT00273572
Brief Title
Lifestyle Intervention in Obese Arab Women
Official Title
The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center
Collaborators
D-Cure, Israel, Chief Scientist, The Israel Ministry of Science

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes
Keywords
Obesity, Women, Arab, Metabolic syndrome, Lifestyle intervention, Quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intensive lifestyle intervention
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Moderate Lifestyle Intervention
Other Intervention Name(s)
Lifestyle intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Intensive lifestyle intervention
Other Intervention Name(s)
Lifestyle intervention
Intervention Description
A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
Primary Outcome Measure Information:
Title
Parameters of the metabolic syndrome
Time Frame
At baseline, and after 6 and 12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
At baseline, and after 12 months
Title
Attainment of weight reduction and physical activity targets
Time Frame
At baseline, and after 6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofra Kalter - Leibovici, M.D.
Organizational Affiliation
Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
City
Tel-Hashomer, Ramat-Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20548010
Citation
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. doi: 10.1001/archinternmed.2010.103.
Results Reference
derived

Learn more about this trial

Lifestyle Intervention in Obese Arab Women

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