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Completed

NCT Number: NCT00273572

Lifestyle Intervention in Obese Arab Women

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

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Key information

Conditions

Metabolic Syndrome Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–54 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Tel-Hashomer, Ramat-Gan, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diabetic

A contraindication for physical activity

Treatment and study plan

Moderate Lifestyle Intervention

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

Other names: Lifestyle intervention

Intensive lifestyle intervention

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

Other names: Lifestyle intervention

Primary outcomes

  1. Parameters of the metabolic syndrome

    Time frame: At baseline, and after 6 and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Chief Scientist, The Israel Ministry of Science
  • D-Cure, Israel

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 9, 2006
Registry last updated
Oct 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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