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Lifestyle Intervention in Obese Arab Women

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ClinicalTrials.gov Identifier: NCT00273572
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : October 29, 2008
Sponsor:
Collaborators:
D-Cure, Israel
Chief Scientist, The Israel Ministry of Science
Information provided by:
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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Diabetes Other: Moderate Lifestyle Intervention Other: Intensive lifestyle intervention Not Applicable

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.

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Study Type : Interventional
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
Study Start Date : December 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Parameters of the metabolic syndrome [ Time Frame: At baseline, and after 6 and 12 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: At baseline, and after 12 months ]
  2. Attainment of weight reduction and physical activity targets [ Time Frame: At baseline, and after 6 and 12 months ]


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Ages Eligible for Study:   35 Years to 54 Years   (Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273572


Locations
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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
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Principal Investigator: Ofra Kalter - Leibovici, M.D. Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ofra Kalter, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00273572     History of Changes
Other Study ID Numbers: SHEBA-04-3335-OK-CTIL
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Sheba Medical Center:
Obesity
Women
Arab
Metabolic syndrome
Lifestyle intervention
Quality of life

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases