Lifestyle Intervention in Obese Arab Women

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273572
• Other study ID #: SHEBA-04-3335-OK-CTIL
• Status: Completed
• Phase: N/A
• First received: January 5, 2006
• Last updated: October 27, 2008
• Start date: December 2004
• Est. completion date: July 2008

Study information

• Verified date: October 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 54 Years

Eligibility

Inclusion Criteria:

• Obesity (BMI: 30-40 kg/squared meter)

• Female Gender

• Being 35-54 years old

Exclusion Criteria:

• Diabetic

A contraindication for physical activity

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	Chief Scientist, The Israel Ministry of Science, D-Cure, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of the metabolic syndrome		At baseline, and after 6 and 12 months	No
Secondary	Quality of life		At baseline, and after 12 months	No
Secondary	Attainment of weight reduction and physical activity targets		At baseline, and after 6 and 12 months	No