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Lifestyle Intervention in Obese Arab Women

NCT ID: NCT00273572

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Diabetes

Keywords

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Obesity Women Arab Metabolic syndrome Lifestyle intervention Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Moderate Lifestyle Intervention

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Intensive lifestyle intervention

Intervention Type OTHER

A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Lifestyle intervention Lifestyle intervention

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diabetic

A contraindication for physical activity
Minimum Eligible Age

35 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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D-Cure, Israel

INDUSTRY

Sponsor Role collaborator

Chief Scientist, The Israel Ministry of Science

UNKNOWN

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ofra Kalter - Leibovici, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tel-Hashomer, Ramat-Gan, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 20548010 (View on PubMed)

Other Identifiers

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SHEBA-04-3335-OK-CTIL

Identifier Type: -

Identifier Source: org_study_id