A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.

UNLABELLED: Incorporating meal replacements has been shown to produce a significantly greater weight loss than a conventional reduced calorie diet. Ready-to-eat conventional foods may also be effective in this role and provide additional benefit because of their palatability, acceptance and enjoyment and thus increase dietary compliance. This trial investigated the efficacy of a ready-to-eat food product (Vita-Weat biscuit) that is both high in carbohydrate and high in protein as part of a diet prescription for weight loss in an overweight and obese population group. A total of 76 participants were randomized to a 6-week weight loss intervention including the ready-to-eat food product (intervention group) or advice on the 'Australian Guide to Healthy Eating' (control group). Both groups lost approximately 2 kg weight which equated to a reduction in body mass index of 0.70 kg m(-2) . There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups; mean difference for the intervention vs. CONTROL GROUP: -0.20% (95% confidence interval: -0.96, 1.36); P = 0.73. Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period. This may have benefit when incorporated into an individual's meal plan intermittently to assist weight control. It also provides support for current public health nutritional guidelines as the participants in this study following such advice were also successful in achieving a clinically meaningful weight loss.

Factors affecting men's liking of condoms they have used.

The objective of this study was to assess the impact on men's liking for the condoms they use of a range of factors including demographic variables and variables that describe men's experience of using particular condoms. One hundred and ninety-four men used 3765 condoms for which they provided a liking rating. The condoms were manufactured to one of 2 published standards and the study employed a double-blind crossover design. Sixty-one per cent of condoms were rated favourably, 31% were rated neutrally and the remainder (8%) unfavourably. Men rated condoms less favourably if they were experienced as too loose, too tight, too short, if difficulty was experienced applying the condom, if the condom slipped partially or completely down the penis or if the condom broke. Men rated more highly condoms which were experienced as well lubricated throughout use. Men with larger penises rated condoms less favourably and, of all the variables considered, ejaculating in the condom was the variable which had the largest positive impact. Men's liking for the condoms they use is influenced by a range of factors. However, given that most of the factors associated with men liking condoms less are those that can be addressed through better condom design and manufacture, the opportunity exists to enhance men's experience of condom use and hence help reduce resistance to the adoption of consistent condom use.

Does penis size influence condom slippage and breakage?

This study examined the effect of penis dimensions on the probability of complete condom slippage and condom breakage in actual use. Men were recruited through advertising, used the condoms supplied and completed a diary sheet for each condom used. A total of 3658 condoms were used by 184 men of which 1.34% broke and 2.05% slipped off. No significant effect was demonstrated for penile dimensions on the probability of complete condom slippage. However, condom breakage was strongly associated with penile circumference. These findings suggest that condom manufacturers may need to increase the range of condom sizes available, or some aspects of their performance, in order to ensure that condoms meet the needs of all men without unduly exposing them to risk.

PIP: Anecdotal reports suggest large penis size may be associated with condom breakage, while small penis size increases the risk of condom slippage. The effect of penis dimensions on the likelihood of both these events was investigated in 184 male volunteers recruited through advertisements and posters in Victoria, Australia. Each participant was provided with 12 condoms at a time and instructed to complete a diary sheet for each condom. According to self-measurements, men had a mean total penis length of 15.71 cm and a mean basal circumference of 13.19 cm. Of the 3658 condoms used by these men, 49 (1.34%) broke and 73 (2.05%) slipped. 30 men (16.3%) experienced at least one instance of breakage and 35 (19.0%) experienced complete slippage. There was no evidence for an effect of penis length or circumference on condom slippage. Condom breakage, on the other hand, was strongly associated with penis circumference. Each additional centimeter of penile circumference increased the risk of condom breakage by 50-100%. This finding suggests a need to increase either the range of condom sizes available or the lateral extension of currently available condoms.

Does additional lubrication affect condom slippage and breakage?

The risk of condom slippage (1.94%) and breakage (0.89%) among 3607 condoms was analysed with respect to the use of additional lubricant. Whether or not lubricant was used, the site at which it was applied and the type of lubricant used were all found to vary significantly with the type of sexual act(s) for which the condoms were used. Little evidence was found for differing effects of type of additional lubricant (water-based, saliva or other) or site of lubricant use (on penis/inside condom, on condom, in vagina/anus). The use of lubricant more than doubles the risk of slippage for vaginal sex. While anal sex is associated with much higher risks of slippage the use of lubricant for this practice actually reduces the risk of slippage to that similar for vaginal sex where lubricant is used. No significant effect of additional lubricant on condom breakage was observed. It is recommended that education messages concerning the use of additional lubricant may need to change to take into account the varied nature of lubricant use practices and the differential effects of lubricant with respect to sexual practices. Specifically, if the use of additional lubricant has little or no impact on condom breakage but increases condom slippage then encouraging its use may be counterproductive if condom users consider slippage to be a reason not to use condoms.

PIP: Findings are reported from a study involving 194 men aged 19-54 years of mean age 30.7 years, and their sex partners, conducted to assess the effect of using supplemental lubricant upon condom slippage and breakage during a range of sex practices. A total 3607 condoms were used by the study participants. 59.8% of the men described themselves as heterosexual, 8.2% as bisexual, and 32% as homosexual. 32 (0.89%) condoms broke either during penetration or were found to have broken once the penis was withdrawn, while 70 (1.94%) slipped completely off of the penis. 5.7% of condoms were used only for oral sex, 58.0% only for vaginal sex, 25.4% only for anal sex, and 10.9% for more than one form of sexual practice. The use of additional lubricant was the norm for anal sex, but it was rarely used for vaginal and oral sex. The site at which additional lubricant was applied and the type of lubricant used varied significantly with the type of sexual acts for which the condoms were used. The use of lubricant was found to increase slippage for oral sex and more than double the risk of slippage during vaginal sex. However, lubricant use for anal sex and multiple practices reduces the risk of condom slippage to a level comparable to that observed for vaginal sex when lubricant is used. No significant effect of additional lubricant on condom breakage was observed. Education messages on the use of additional lubricant should take into account the range of different sex and lubricant use practices.

An actual use comparison of condoms meeting Australian and Swiss standards: results of a double-blind crossover trial.

The performance of condoms in actual use has been poorly researched in the past, especially in comparing condoms that met different quality control standards as indicated by laboratory testing. The present study used a double-blind crossover design to compare the performance of 2 types of condoms in actual use; one that met the Australian and International Organization for Standardization (ISO) standards for condom quality and one that met the more stringent Swiss Quality Seal requirements. Ninety-two men recruited from Metropolitan Melbourne completed a self-report diary sheet after each condom was used which assessed the performance of the condom and the conditions under which it was used. From a total of 1917 condom uses, there was an overall breakage risk of 2.7%. The breakage risk ratio (Australian/ISO:Swiss) for all types of use was 1.16 (95% confidence interval 0.68-1.99). When subanalyses by method of entry were performed, the condoms meeting the Swiss standard appeared to fare better than the Australian/ ISO standards for anal sex (RR = 4.84, 95% CI 1.07-21.8, P = 0.022), while the opposite was the case for vaginal sex (RR = 0.74, 95% CI 0.35-1.53, P = 0.41). The result for anal use was statistically significant at the 5% level, despite being based on fewer condom trials than that for vaginal use, but this result needs to be replicated. Although the participants appeared representative of the general male population in Melbourne in the age bracket 18-46 years, there was a significant history of condom usage reported. This may have influenced the risk of breakage.

Interaction of condom design and user techniques and condom acceptability.

In 1991, the source of public sector condom supplies in an African country changed from USAID to WHO. Following a complaint, the two types of condoms were sampled and compared. Laboratory tests indicated that the new-style condoms were of adequate quality, but a number of differences were noted between the two types. Complaints that the condoms were short and broke frequently could not be reconciled with measurements. Lubricant quantities on the WHO-supplied condoms were found to be lower than on the USAID condoms, but still within the range found on the commercial market. Also, the WHO condoms were marginally narrower and thicker. WHO asked the authors to conduct field interviews to seek reasons for the reported problems. These revealed that the relative dissatisfaction with the WHO condoms was largely confined to a group of sex workers in a follow-up programme conducted by two educators funded by a European agency. The instructions for use being given by the educators magnified the risk of incorrect application of the condom. Design changes to the WHO condoms (regarding lubricant, size and thickness) were subsequently made to minimise the chance of wrong use.

PIP: In November 1991 in Cotonou, Benin, 30 sex workers complained that the World Health Organization (WHO) blue condoms were not as good as the USAID condoms. The National AIDS Programme had replaced the USAID condoms with WHO condoms. Leading complaints about WHO condoms were in order of importance: causes pain in vagina, too short, too small, insufficient lubrication, breaks easily, and several condoms needed per client due to breakage. Samples of both condoms underwent laboratory tests to learn more about the complaints. Informal interviews were conducted with professionals in contact with users (e.g., family planning workers and condom vendors) and condom users (prostitutes, bar girls, and men). There were some differences between the two condom types. For example, the USAID condom exerted 20-30% less pressure on the penis than the WHO condom. However, researchers considered the differences to be too small to completely explain the complaints. Two social workers had done a suboptimal job of explaining to sex workers how to unroll condoms. Other than these sex workers, others accepted the WHO condom well. Both condoms had at least the same strength, suggesting that other factors likely explain the complaints (e.g., breakage). The WHO condom had less lubricant than the USAID condom (223 vs. 451 mg), yet the amount was within the range of that on the commercial market. One batch of WHO condoms had much less lubricant than other WHO batches. Even though the sex workers complained that the WHO condom was too short, it was actually longer than the USAID condom, suggesting that the WHO condoms were not unrolled completely. These findings indicate the need to teach correct application procedures to condom users and to make condoms as immune as possible to incorrect or suboptimal techniques (e.g., changes in lubricant).

Why do condoms break or slip off in use? An exploratory study.

Men attending 3 sexually transmissible disease clinics and a university health clinic in Sydney, Australia, were invited to complete a questionnaire on their use of condoms. Respondents were 108 male condom user volunteers aged 18 to 62 years; in the last five years 47 had had sex with men, 18 with both men and women and 43 only with women. They reported using a total of 4809 condoms in the previous 12 months (condoms worn by a male partner were not included). The overall breakage rate was 4.9% (including condoms breaking during application), while 3.1% of condoms reportedly slipped off. On a multivariate analysis, condom breakage correlated with: (1) male sexual partner(s), (2) infrequent condom use, (3) rolling the condom on as per conventional instructions (modified application methods appeared protective) and (4) having trouble with condoms partially slipping. Factors associated with condoms slipping off were (1) young age, (2) being circumcised, (3) having less life-time condom experience, (4) rolling the condom on conventionally, and (5) having trouble with condoms partially slipping. Few men used inappropriate lubricants and no association between lubricant type and breakage was found. Though common among our respondents, negative attitudes towards condoms, loss of erection during condom application or use, finding condoms uncomfortable, and prolonged sexual intercourse were not related to success in use. Almost half (49%) of the men reported having deliberately removed a condom after the beginning of intercourse; 17% had done so 3 or more times. Counselling protocols should acknowledge the complexity of condom use.(ABSTRACT TRUNCATED AT 250 WORDS)

How often do condoms break or slip off in use?

Men attending 3 sexually transmissible disease clinics and a university health service in Sydney were given a questionnaire asking how many condoms they had used in the past year and how many broke during application or use or slipped off. Respondents were 544 men aged 18 to 54 years. Of these, 402 men reported using 13,691 condoms for vaginal or anal intercourse; 7.3% reportedly broke during application or use and 4.4% slipped off. Men having sex with men reported slightly higher slippage rates than those having sex with women. Breakage and slippage were unevenly distributed among the sample: a few men experienced very high failure rates. A volunteer subsample reported 3 months later on condoms supplied to them: 36 men used 529 condoms, of which 2.8% broke during application or use and 3.4% slipped off. Many of these failures pose no risk to the user, especially those occurring during application, as long as they are noticed at the time, but failure may discourage future use. Research is needed to identify user behaviours related to breakage.

A study of the relationship between tensile testing of condoms and breakage in use.

The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from holes, an inflation test, and tensile testing. In this study we subjected condoms that had broken in use to tensile tests in order to determine any correlation between their in vivo and in vitro performance. Condoms which had broken in use showed similar tensile properties to those which had not. All passed all tensile test criteria. Thus, the inclusion of tensile testing in National Standards for condoms is not sufficient to insure strong products.