Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.
Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).
The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.
|Erectile Dysfunction||Behavioral: Lifestyle - detailed advice Behavioral: Control - general information|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.|
- IIEF (International Index Erectile Function) [ Time Frame: two years ]
- Endothelial function, Circulating inflammatory markers [ Time Frame: two years ]
|Study Start Date:||October 2000|
|Study Completion Date:||October 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
Behavioral (Lifestyle Counseling)
Behavioral: Lifestyle - detailed advice
Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity
Active Comparator: 2
Behavioral: Control - general information
General information about healthy food choices and exercise
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636688
|Study Director:||Dario Giugliano, MD,PhD||Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy|