ISRCTN25796154
Completed
Not Applicable
Effects of a 12-month lifestyle modification with or without training program in overweight and obese women at high risk of diabetes in the early menopause stage: A 3-arm, randomised controlled trial
niversity of Ottawa (Canada)0 sites120 target enrollmentSeptember 21, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Ottawa (Canada)
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 10/01/2012
- •Participants \- inclusion criteria
- •1\. Women aged 45 years or older.
- •2\. Overweight or obese (BMI higher than 27 kg/m2 and lower than 40 kg/m2\)
- •3\. Women with menstrual irregularities or without menses for 48 months or less
- •4\. Non\-smokers
- •5\. Low to moderate alcohol consumers (less than 2 drinks/day)
- •6\. Sedentary (less than 30 minutes of exercise per week)
- •7\. Total risk score \=12 from the type 2 diabetes risk assessment form
- •Previous inclusion criteria
Exclusion Criteria
- •1\. Pregnant or who plan to become pregnant
- •2\. Women with medical problems and/or are taking medications which may impact on menopause or on study outcome
- •3\. Women who had hysterectomy or bi\-lateral ovariectomy
- •4\. Known diabetes
- •5\. Known coronary heart disease
Outcomes
Primary Outcomes
Not specified
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