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The men were randomised to Weight Watchers weight loss programme plus placebo versus the same weight loss programme plus testosteroneundecanoate; neither group lost any weight. We had previously shown no difference in weight loss after testosterone had been discontinued due to lack of effect.15, 16 All patients completed 2 weeks of a weight loss programme followed by 3 to 11 weeks of the placebo program. Randomisation to the Weight Watchers programme had been done by a computer-generated random number table, which was approved by the Regional Medical Ethics Committee of the Central Research Department of the South-west University Hospital in the University of South-East England before randomisation.Data collectionBetween March 1995 and June 1997 30 patients signed up for the study and were followed up up for a total of 18 months (average of 4 months) with each patient completing two 6-month dietary records during this period. Participants recorded the amount of food on their first day of randomisation and their total daily energy intake (kJ/d) over the following 3 months. At baseline the food records included:a weight for height (BMI) and body density calculated from photographs taken before randomisation and for those assigned to the Weight Watchers programme. BMI is a ratio of a person's height and weight (kg) and is based on a person's height and weight.17, 18 BMI is also expressed as kg/m2.A record of whether the participant had experienced anemia during the previous four months.A record of the time spent in bed as measured by a handheld noninvasive diathermy system, which was available at home during a visit, and if it had been used. If the participant used this device, they were coded as sleeping for 1–4 hours per evening.The total amount of physical activity per week, calculated as the time spent doing physical activity (eg walking, lifting weights, doing manual tasks) per week. Activities were recorded on a log; this time was also taken up during a visit. If participants did not perform physical activity for several days on weekdays then the activity for both days was excluded from the calculation. This method of calculating time spent doing physical activity is not validated in individuals who sleep less than 3 hours per night.19 The exercise data recorded during the study were classified according to the World Health Organization definition of 'minimal physical disability'. The physical activity data used in this study were not validated for individuals who sleep less than 3 hours per night.Cardiovascular parameters, measured with the use of an electrocardiograph (ECG).20A complete bloodRelated Article: