Lifestyle Intervention in Obese Arab Women

Sheba Medical Center

Status: Completed

Conditions: Diabetes; Metabolic Syndrome

Treatments: Other: Intensive lifestyle intervention; Other: Moderate Lifestyle Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00273572

SHEBA-04-3335-OK-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 35 to 54 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Moderate lifestyle intervention

Active Comparator group

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.

Treatment:

Other: Moderate Lifestyle Intervention

Intensive lifestyle intervention

Experimental group

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.

Treatment:

Other: Intensive lifestyle intervention