Diabetes, Metabolic Syndrome
Conditions
Keywords
Obesity, Women, Arab, Metabolic syndrome, Lifestyle intervention, Quality of life
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.
Interventions
OTHERModerate 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
OTHERIntensive 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
Sponsors
D-Cure, Israel
Chief Scientist, The Israel Ministry of Science
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Obesity (BMI: 30-40 kg/squared meter) * Female Gender * Being 35-54 years old
Exclusion criteria
* Diabetic A contraindication for physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters of the metabolic syndrome | At baseline, and after 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | At baseline, and after 12 months |
| Attainment of weight reduction and physical activity targets | At baseline, and after 6 and 12 months |
Countries
Israel
Outcome results
None listed