Clinical trial NCT00273572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Diabetes
Keywords: Obesity
Women
Arab
Metabolic syndrome
Lifestyle intervention
Quality of life
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: D-Cure, Israel
name: Chief Scientist, The Israel Ministry of Science
First posted: 2006-01-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Parameters of the metabolic syndrome
timeFrame: At baseline, and after 6 and 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: At baseline, and after 12 months
measure: Attainment of weight reduction and physical activity targets
timeFrame: At baseline, and after 6 and 12 months
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat-Gan
country: Israel
facility: Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Study officials:
affiliation: Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL
name: Ofra Kalter - Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.