The efficacy of female condom skills training in HIV risk reduction among women: a randomized controlled trial

Objectives. We evaluated the efficacy of skills training designed to increase female condom use among women.Methods. We conducted a randomized controlled trial of 409 women, recruited from family planning clinics in northern California, who were randomly assigned to the experimental 4-session female condom skills training intervention or the comparison 4-session women''s general health promotion intervention. Participants received condom use instructions at baseline and male and female condoms during the study. They completed audio computer-assisted self-interviews at baseline and at 3 and 6 months.Results. At 3 and 6 months, women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months. The increase in the percentage of sexual acts protected by female condoms from baseline to the 6-month follow-up was greater for the experimental group. The percentage of sexual acts during which any condom was employed was higher in the experimental group at 6 months. There were no group differences in male condom use.Conclusions. Outcomes suggest that skills training can increase female condom use and protected sexual acts without reducing male condom use among women.Women account for almost half of the 40 million estimated human immunodeficiency virus (HIV) infections worldwide.¹ Effective female condom promotion programs that could help facilitate more-widespread use of the device could have a significant impact on reducing the incidence of HIV among women and their sexual partners. The female condom, a polyurethane sheath worn inside the vagina, is the only female-initiated barrier method currently available to protect against HIV and other sexually transmitted infections (STIs).² Early acceptability studies have shown that the female condom is a promising disease prevention option for diverse subpopulations of women in developing and developed countries.^3–7 Among US women attending family planning clinics, 82% of respondents who were introduced to the female condom at their baseline visit reported having used the device at least once during the 3-month study period.⁷ However, women''s initial interest in the product has not moved beyond the “novelty” phase,^2,5,8 and its uptake has been limited because it has not been promoted actively by the private or public sectors in this country.^2,5 US studies have found low levels of lifetime use, ranging between 3% and 6%.^9–11Few clinical trials have demonstrated efficacy in any intervention designed to increase female condom use. Five published US studies evaluated female condom interventions with a randomized controlled design,^9–13 and only 2 of these^9,12 demonstrated effects on ever-use or first-time use over a short term (i.e., 6 weeks and 1 month). Three studies found an increase in use of female condoms during sexual acts, but included a follow-up of only 3 months.^10,11,13 Moreover, 1 of these studies had a small sample size (n = 81),¹³ whereas the other 2 did not match treatment dosage and compared a multisession experimental intervention with a single-session control intervention.^10,11We conducted a randomized trial with a sample of 409 US women to test the hypothesis that female condom skills training would be efficacious in increasing sustained use of female condoms and protected sex. We matched the length and delivery mode of the intervention for experimental and comparison groups and assessed both short- and longer-term effects (i.e., 3 and 6 months).     

HOP'N after-school project: an obesity prevention randomized controlled trial

Background  

This paper reports the primary outcomes of the Healthy Opportunities for Physical Activity and Nutrition (HOP'N) after-school project, which was an effectiveness trial designed to evaluate the prevention of childhood obesity through building the capacity of after-school staff to increase physical activity (PA) and fruit and vegetable (FV) opportunities.     

Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial

Objective

To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic (PK) alterations caused by obesity during oral contraceptive (OC) use.

Study design

Obese [body mass index (BMI)≥30 kg/m²], ovulatory, otherwise healthy, women received an OC containing 20 mcg ethinyl estradiol (EE)/100 mcg levonorgestrel (LNG) dosed cyclically (21 days active pills with 7-day placebo week) for two cycles and then were randomized for two additional cycles to the following: continuous cycling (CC, a dose neutral arm using the same OC with no hormone-free interval) or increased dose (ID, a dose escalation arm using an OC containing 30 mcg EE/150 mcg LNG cyclically). During Cycles 2, 3 and 4, outpatient visits were performed to assess maximum serum concentration (C_max), area under the curve (AUC_0–∞) and time to steady state as well as pharmacodynamics. These key PK parameters were calculated and compared within groups between baseline and treatment cycles.

Results

A total of 31 women enrolled and completed the study (CC group, n=16; ID group, n=15). Demographics were similar between groups [mean BMI: CC, 38 kg/m² (S.D. 5.1); ID, 41 kg/m² (S.D. 7.6)]. At baseline, the key LNG PK parameters were no different between groups; average time to reach steady state was 12 days in both groups; C_max were CC: 3.82±1.28 ng/mL and ID: 3.13±0.87 ng/mL; and AUC_0–∞ were CC: 267±115 h ng/mL and ID: 199±75 h ng/mL. Following randomization, the CC group maintained steady-state serum levels whereas the ID group had a significantly higher C_max (p<.001) but again required 12 days to achieve steady state. However, AUC was not significantly different between CC (412±255 h ng/mL) and ID (283±130 h ng/mL). Forty-five percent (14/31) of the study population had evidence of an active follicle-like structure prior to randomization and afterwards this decreased to 9% (3/31).

Conclusion

Both increasing the OC dose and continuous dosing appear to counteract the impact of obesity on key OC PK parameters.

Implications

Obesity adversely affects the pharmacokinetics of very low dose OC pills. Although the impact of these changes on OC efficacy is still under debate, PK parameters can be normalized in obese users by continuous dosing or increasing to a low-dose pill.     

Exercise and self-esteem in menopausal women: a randomized controlled trial involving walking and yoga

PURPOSE: To examine the effects of walking and yoga on multidimensional self-esteem and roles played by self-efficacy, body composition, and physical activity (PA) in changes in esteem. DESIGN: Four-month randomized controlled exercise trial with three arms: walking, yoga, and control. SUBJECTS: Previously low-active middle-aged women (n=164; M age = 49.9; SD = 3.6). INTERVENTION: Structured and supervised walking program meeting three times per week for I hour and supervised yoga program meeting twice per week for 90 minutes. MEASURES: Body composition, fitness assessment, and battery of psychologic measures. ANALYSIS: Panel analysis within a structural equation modeling framework using Mplus 3.0. RESULTS: The walking and yoga interventions failed to enhance global or physical self-esteem but improved subdomain esteem relative to physical condition and strength (for walking) and body attractiveness (for both walking and yoga). Over time the effects of PA, self-efficacy, and body fat on changes in physical self-esteem and global esteem were mediated by changes in physical condition and body attractiveness subdomain esteem. Women reporting greater levels of self-efficacy and PA with lower body fat also reported greater enhancements in subdomain esteem. CONCLUSION: These results provide support for the hierarchic and multidimensional nature of self-esteem and indicate that middle-aged women may enhance certain aspects of physical self-esteem by participating in PA.     

Efficacy of psychotherapy for anxiety reduction in hospital management of women successfully treated for preterm labor: a randomized controlled trial

ABSTRACT

Preterm labor (PTL) is associated with high anxiety and stress in pregnant women. The study investigated the effect of adding psychotherapy to hospital management of pregnant women with successfully treated for PTLon improving anxiety, pregnancy stress, and perceived control. In a randomized controlled trial study, sixty pregnant women with gestational ages of 24 to 37 weeks and successfully treated forPTL were randomly divided into the experimental (n = 30) and control group (n = 30). The experimental group received psychotherapy along with medical care in individual face-to-facesessions, 1 h per day for 6 consecutive days.The control group received medical care for PTL. Objective outcomes were assessed via the State-Anxiety Inventory, Prenatal Distress Questionnaire (NuPDQ), and Perceived Pregnancy Control at pre-trial and post-trial. The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention. The findings suggest that adding psychotherapy to hospital management of women successfully treated for PTLcan be considered a potential method to reduce anxiety and pregnancy-specific stress.     

Eating control and eating behavior modification to reduce abdominal obesity: a 12-month randomized controlled trial

BACKGROUND/OBJECTIVESAbdominal obesity is associated with metabolic disorders, and, in recent years, its prevalence in Korea has continuously increased. The change of lifestyle, particularly diet, is critical for the reduction of abdominal obesity. This study evaluated the effectiveness of an intervention focused on dietary self-efficacy and behaviors on the improvement of abdominal obesity.SUBJECTS/METHODSAbdominally obese adults with additional cardiovascular risk factors were recruited through 16 medical facilities in South Korea from the year 2013 to 2014. The participants were randomly divided into 2 groups: an intensive intervention group (IG) that received a multi-component intervention to reduce abdominal obesity, by mainly focusing on dietary attitude and dietary behavior change, and a minimal information intervention group (MG) that received a brief explanation of health status and a simple recommendation for a lifestyle change. The interventions were provided for 6 mon, and health examinations were conducted at baseline, 3-, 6-, and 12-mon follow-ups. A path analysis was conducted to identify the process governing the changes in abdominal obesity.RESULTSThe IG showed an improvement in self-efficacy for eating control and diet quality at 6-mon follow-up. Abdominal obesity improved in both groups. Waist circumference was observed to be decreased through the path of “improved self-efficacy for eating control in food availability—eating restriction—improved dietary quality” in IG. Most changes in follow-ups were not significantly different between two groups.CONCLUSIONSThe intensive program targeting the modification of dietary behavior influenced management of abdominal obesity, and the effect occurred through a step-by-step process of change in attitude and behavior. Generally, improvements were also seen in the MG, which supports the necessity of regular health check-ups and brief consultation. The results can be used for further development and implementation of more successful interventions.Trial RegistrationClinical Research Information Service Identifier: KCT0000762     

Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren

BACKGROUND: Childhood obesity is a major public health problem in the United States, particularly among American Indian communities. OBJECTIVE: The objective was to evaluate the effectiveness of a school-based, multicomponent intervention for reducing percentage body fat in American Indian schoolchildren. DESIGN: This study was a randomized, controlled, school-based trial involving 1704 children in 41 schools and was conducted over 3 consecutive years, from 3rd to 5th grades, in schools serving American Indian communities in Arizona, New Mexico, and South Dakota. The intervention had 4 components: 1) change in dietary intake, 2) increase in physical activity, 3) a classroom curriculum focused on healthy eating and lifestyle, and 4) a family-involvement program. The main outcome was percentage body fat; other outcomes included dietary intake, physical activity, and knowledge, attitudes, and behaviors. RESULTS: The intervention resulted in no significant reduction in percentage body fat. However, a significant reduction in the percentage of energy from fat was observed in the intervention schools. Total energy intake (by 24-h dietary recall) was significantly reduced in the intervention schools but energy intake (by direct observation) was not. Motion sensor data showed similar activity levels in both the intervention and control schools. Several components of knowledge, attitudes, and behaviors were also positively and significantly changed by the intervention. CONCLUSIONS: These results document the feasibility of implementing a multicomponent program for obesity prevention in elementary schools serving American Indian communities. The program produced significant positive changes in fat intake and in food- and health-related knowledge and behaviors. More intense or longer interventions may be needed to significantly reduce adiposity in this population.     

Preventing alcohol-exposed pregnancies: a randomized controlled trial

BACKGROUND: Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. DESIGN: A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. SETTING/PARTICIPANTS: A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). INTERVENTIONS: Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. MAIN OUTCOME MEASURES: Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. RESULTS: Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. CONCLUSIONS: A brief motivational intervention can reduce the risk of an AEP.     

Retaining women in a prenatal care randomized controlled trial in Canada: implications for program planning

Background:  

Challenges to retention in prenatal care seem to exist under both universal systems of care, as in Canada, and non-universal systems of care, as in the United States. However, among populations being served by a system of publicly funded health care, the barriers are less well understood and universal uptake of prenatal services has not been realized. Determining the characteristics of women who dropped out of a prenatal care randomized controlled trial can help identify those who may need alternate retention and service approaches.     

Alcohol and high-density-lipoprotein cholesterol: a randomized controlled trial

1. A randomized controlled trial of cross-over design was set up to examine the effect of alcohol on blood lipids and certain haematological variates relevant to ischaemic heart disease. 2. One hundred subjects drank some alcohol for 4 weeks (mean intake 18.4 g/d) and abstained totally for 4 weeks, the order of these periods being randomized. 3. Alcohol appeared to produce a rise of 7% in serum high-density-lipoprotein (HDL) cholesterol, probably due to a rise in the HDL2 subfraction. 4. No significant change was detected in plasma fibrinogen or the other haematological indices. 5. These results are consistent with the hypothesis that a moderate intake of alcohol confers some protection against heart disease.     

Dieting and the development of eating disorders in obese women: results of a randomized controlled trial

BACKGROUND: Some investigators fear that dieting may precipitate binge eating and other adverse behavioral consequences. OBJECTIVE: The objective of the study was to examine whether dieting would elicit binge eating and mood disturbance in individuals free of these complications before treatment. DESIGN: A total of 123 obese women were randomly assigned to 1) a 1000 kcal/d diet that included 4 servings/d of a liquid meal replacement (MR); 2) a 1200-1500 kcal/d balanced deficit diet (BDD) of conventional foods; or 3) a nondieting (ND) approach that discouraged energy restriction. All women attended weekly group sessions for 20 wk and biweekly sessions from week 20 to week 40. RESULTS: At week 20, participants in the MR, BDD, and ND groups lost 12.1 +/- 6.7%, 7.8 +/- 6.0%, and 0.1 +/- 2.4% of initial weight, respectively (P < 0.001). During the first 20 wk, there were no significant differences among groups in the number of persons who had objective binge episodes or in reports of hunger or dietary disinhibition. Symptoms of depression decreased significantly more (P < 0.001) in the MR and BDD groups than in ND participants. At week 28, significantly more (P < 0.003) cases of binge eating were observed in MR participants than in the 2 other groups. No differences, however, were observed between groups at weeks 40 or 65 (a follow-up visit). At no time did any participant meet criteria for binge-eating disorder. CONCLUSION: Concerns about possible adverse behavioral consequences of dieting should not dissuade primary care providers from recommending modest energy restriction to obese individuals.     

Evaluation of a "nondieting" stress reduction program for overweight women: a randomized trial

PURPOSE: Determine if a "nondieting" intervention focused on intensive training in eliciting the relaxation response enhances health outcomes compared with nondieting interventions without such training. DESIGN: Randomized trial with follow-up at 10 weeks, 4 months, and 12 months. SETTING: General community. SUBJECTS: Total of 225 overweight and obese women with at least one other cardiovascular risk factor. INTERVENTIONS: Three 10-week nondieting interventions: a group program (P1) focused on intensive training in techniques for eliciting the relaxation response (n = 60), a group program (P2) focused on healthy eating and physical activity (n = 61), and a self-guided, mail-delivered version of P2 (P3; n = 101). MEASURES: The Revised Symptom Checklist measured psychological distress, the Medical Symptoms Checklist measured the experience of medical symptoms, and the Health-Promoting Lifestyle Profile measured a range of lifestyle behaviors. Self-efficacy for low-fat eating intuitive eating, and body mass index were also assessed. ANALYSIS: An intention-to-treat analysis was used. RESULTS: At 12 months, P1 produced statistically greater improvements in stress management behaviors and medical symptom discomfort and was the only program to significantly improve self-efficacy for low-fat eating. In P1, the effect sizes for reductions in depression (0.75) and interpersonal sensitivity (0.85) were large. At 12 months, mean weight was unchanged. CONCLUSION: Inclusion of intensive relaxation response training in a nondieting program for overweight women enhanced stress management and medical symptoms outcomes but not weight outcomes.     

Efficacy of a health educator-delivered HIV prevention intervention for Latina women: a randomized controlled trial

Objectives. We developed and assessed AMIGAS (Amigas, Mujeres Latinas, Inform andonos, Gui andonos, y Apoy andonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally congruent HIV prevention intervention for Latina women adapted from SiSTA (Sistas Informing Sistas about Topics on AIDS), an intervention for African American women.Methods. We recruited 252 Latina women aged 18 to 35 years in Miami, Florida, in 2008 to 2009 and randomized them to the 4-session AMIGAS intervention or a 1-session health intervention. Participants completed audio computer-assisted self-interviews at baseline and follow-up.Results. Over the 6-month follow-up, AMIGAS participants reported more consistent condom use during the past 90 (adjusted odds ratio [AOR] = 4.81; P < .001) and 30 (AOR = 3.14; P < .001) days and at last sexual encounter (AOR = 2.76; P < .001), and a higher mean percentage condom use during the past 90 (relative change = 55.7%; P < .001) and 30 (relative change = 43.8%; P < .001) days than did comparison participants. AMIGAS participants reported fewer traditional views of gender roles (P = .008), greater self-efficacy for negotiating safer sex (P < .001), greater feelings of power in relationships (P = .02), greater self-efficacy for using condoms (P < .001), and greater HIV knowledge (P = .009) and perceived fewer barriers to using condoms (P < .001).Conclusions. Our results support the efficacy of this linguistically and culturally adapted HIV intervention among ethnically diverse, predominantly foreign-born Latina women.Latinos are the largest and fastest-growing ethnic minority in the United States, currently composing 15% of the US population.¹ Between 2000 and 2006, Latinos accounted for almost half of all US population growth, with nearly 40% of this increase attributed to foreign-born Latinos.² Latinos are also disproportionately affected by the HIV epidemic.³ Between 2003 and 2006, more than half of Latinos diagnosed with HIV were foreign born, and the majority lived in the southern United States.⁴ The Miami, Florida, metropolitan area has the highest rate of new AIDS diagnoses in the United States (42.8/100 000 population)⁵ as well as a highly diverse Latino population.⁶ Thus, HIV prevention efforts for Latinos in Miami must address this diversity.HIV diagnoses among Latina women (15/100 000) are 5 times the rate for White women, and annual HIV diagnoses have increased among foreign-born Latina women.³ In addition to language barriers and lack of access to regular health care, adherence to traditional gender roles can increase foreign-born Latina women''s vulnerability to HIV.^7–9 Widespread cultural values such as marianismo (Marianism), which stresses chastity before marriage and faithfulness, sexual passivity, and subservience after marriage, and simpatía, which stresses the importance of being agreeable and nonconfrontational in social relationships, can make negotiating and practicing safe sex challenging for Latina women.^10,11Although Latina women are disproportionately affected by HIV/AIDS, they remain an understudied and underserved population. Recent meta-analyses reveal that few HIV sexual risk reduction interventions have demonstrated efficacy in decreasing HIV-associated behaviors among adult Latina women,¹² and available interventions do not address the cultural diversity of Latina women.¹³ We developed AMIGAS (Amigas, Mujeres Latinas, Informándonos, Guiándonos, y Apoyándonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally appropriate adaptation of SiSTA (Sistas Informing Sistas about Topics on AIDS), a widely disseminated HIV risk-reduction intervention initially developed for African American women,¹⁴ and assessed its efficacy in a randomized, controlled trial. AMIGAS was delivered by Latina health educators to a diverse, predominantly immigrant population of Latina women in the Miami metropolitan area.