Standard Intervention Group Research Articles

Comparing the sustainability of an Islamic dietary intervention to maintain weight loss 6 months after Ramadan between intervention and control groups

Introduction: Maintaining weight loss after the initial phases of any weight loss intervention is a challenge. Rationally, it depends on how well the adherence is to the prescribed treatment. This study is to test the sustainability of an intervention in maintaining weight lost during Ramadan by using voluntary fasting. Methods: Two groups of respondents (Muslim women with body mass index (BMI) ≥ 25.0 kg/m2) were randomly recruited from two states in Malaysia. One group received the Islamic based intervention (Group A) and the other received the standard intervention (Group B). The intervention consisted of three phases. The first phase was the intensive phase which was the control of food quantity intake during the fasting month of Ramadan. The second phase was the maintenance phase where the respondents were assisted to continue monitoring their food consumption using the food diary for 3 months and the third phase was the following 3 months without any assistance. The variables studied were BMI, blood pressure (systolic and diastolic pressure) and selected blood biochemical (i.e. total cholesterol (TC) and high density lipoprotein (HDL-C)). Variables were measured at baseline, at the end of Ramadan and at 6 months post Ramadan. Results: At 6 months post Ramadan the BMI, diastolic pressure, TC, HDL-C and TC/HDL-C ratio changes were different between the two groups (except for BMI changes where P=0.02, all others P

Effects of early physiotherapy with respect to severity of pneumonia of elderly patients admitted to an intensive care unit: a single center study in Japan.

[Purpose] We performed early physiotherapy for elderly patients with pneumonia admitted to an intensive care unit (ICU), and examined the effects of this early physiotherapy on the severity of pneumonia. [Subjects and Methods] Patients for whom physiotherapy was started the day after admission to the ICU (acute phase) were assigned to the early intervention group and compared with patients in the standard intervention group. All patients were divided into three groups (Groups I, II, and III) based on the severity of pneumonia. We evaluated the ICU admission period, hospitalization period, and activities of daily living (ADL) before and after admission. [Results] With respect to the severity of pneumonia, Group II showed significant differences in the ICU admission period and rates of change in the operating range, cognitive domain, and Functional Independence Measure (FIM). Group III showed significant differences in the ICU admission period and rate of change in the cognitive domain (FIM item). The results were more favorable in the early intervention group than in the standard intervention group. [Conclusion] The ICU admission period was shorter and a reduction in the ADL level was prevented in Groups II, and III compared to Group I. This may have occurred because of the early rehabilitation.

Assessment of a pharmacist-led comprehensive medication management and wellness program

Background: Pharmacists are currently providing comprehensive medication management in the outpatient setting. However, there is little documented evidence demonstrating pharmacists are generating further improved health outcomes utilizing non-pharmacologic support, such as fitness and nutrition counseling. The objective of this study is to determine if a pharmacist-led wellness program with medication management and lifestyle modifications through fitness and nutrition coaching can lead to improved biometric markers.
 Methods: The wellness program targeted corporate employees and was offered in a corporate headquarters' setting with an on-site workout facility. The program was expected to recruit approximately 15 patients into the wellness program consisting of two treatment arms. The standard group featured nutrition-based classes, medication therapy management and fitness education. The intervention group performed the standard group's activities plus direct, supervised fitness training once weekly. Measured biometric markers were assessed at baseline, 3.5 months, and 7 months and included body mass index (BMI), waist circumference (WC), fasting blood glucose (FBG), systolic and diastolic blood pressure (SBP and DBP), and full lipid panel (TC, TG, HDL, and LDL).
 Results: Seventeen patients were enrolled in the study. The standard group (n = 11) and intervention group (n = 6) had relatively similar biometric markers at baseline. Seven total patients completed the study (4 from standard group, 3 from intervention group). The majority of biometric markers improved in both groups, and BP and LDL control was maintained for all who completed the study.
 Conclusion: These data suggest that a licensed pharmacist with certified personal trainer credentials may be capable of maintaining biometric markers at healthy levels and improving where necessary in an employee wellness program through one-on-one medication, fitness and nutrition support. Additional, large-scale research is needed to verify the clinical outcomes and feasibility in a larger group setting.
 
 Type: Clinical Experience

Long-term effects of an intensive intervention in HIV-infected patients with moderate-high atherosclerotic cardiovascular risk.

To evaluate the 5 year effects of an intensive intervention versus the standard-of-care intervention on cardiovascular risk factors in HIV-infected patients on antiretroviral therapy (ART). This was a longitudinal study including virologically suppressed patients with at least two cardiovascular risk factors or a Framingham risk score ≥10%. Intensive and standard-of-care interventions aimed for low-density lipoprotein cholesterol (LDL-C) <100 and <130 mg/dL, respectively, by using lipid-lowering drugs. In the intensive group, switching ART when needed to achieve the LDL-C target and low-dose aspirin were used. Achievement of LDL-C targets and changes in carotid intima-media thickness (cIMT) and cardiovascular biomarkers were compared between groups at different timepoints through a 5 year period. Twenty-two and 25 patients in the intensive and standard intervention groups, respectively, were followed up. At 5 years, pre-specified LDL-C targets were achieved in 82% (intensive) and 81% (standard of care) of patients. The median (IQR) change in LDL-C in the intensive and standard intervention groups was -78 (-96/-39.7) and -49 (-72/-3) mg/dL, respectively (P = 0.04), and in the Framingham score was -4% (-8%/-1%) and 0% (-4%/6.5%), respectively (P = 0.01). There were no significant intra- or between-group changes in cIMT measurements. A significant decrease was observed in the intensive and standard groups in interleukin 6 (P = 0.001 and P = 0.002, respectively) and in tumour necrosis factor α (P = 0.023 and P = 0.052, respectively). Asymptomatic creatine phosphokinase elevations were observed in two patients assigned to the standard intervention group. An intensive intervention on cardiovascular risk factors in HIV-infected patients on ART was feasible, safe and capable of achieving LDL-C targets in the long term. Both intensive and standard interventions were accompanied by antiatherosclerotic changes in inflammatory cytokines and lack of cIMT progression.

The effect of triclosan coated sutures on rate of surgical site infection after hip and knee replacement: a protocol for a double-blind randomised controlled trial.

Background187,000 hip and knee joint replacements are performed every year in the National Health Service (NHS). One of the commonest complications is surgical site infection (SSI), and this represents a significant burden in terms of patient morbidity, mortality and cost to health services around the world. The aim of this randomised controlled trial (RCT) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement (TKR) and total hip replacement (THR).Methods2400 patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT. Participants are recruited before surgery and randomised to either standard care or intervention group. Participants, outcome assessors and statistician are blind to treatment allocation throughout the study. The intervention consists of triclosan coated sutures vs. standard non-coated sutures. The primary outcome is the Health protection Agency (HPA) defined superficial surgical site infection at 30 days. Secondary outcomes include HPA defined deep surgical site infection at 12 months, length of hospital stay, critical care stay, and payer costs.DiscussionTo date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention, particularly those that can be translated across the surgical specialities. The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement. If triclosan coated sutures are found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement.Trial registrationCurrent Controlled Trials ISRCTN 17807356.

Predictors of colorectal cancer screening adherence among African Americans.

1501 Background: Low colorectal cancer (CRC) screening rates among African Americans (AAs) contribute to higher CRC mortality and lower CRC survival among AAs than whites. We conducted a randomized controlled trial to determine if a preference-based mail and telephone navigation intervention could increase CRC screening adherence among AA patients. Methods: The trial included AA patients who were 50-75 years old, eligible for screening, and received care through primary care practices in Philadelphia. Eligible patients (n=764) were consented, surveyed by telephone, and randomized to a Standard Intervention (SI) Group (n=380) or Tailored Navigation Intervention (TNI) Group (n=384). The SI Group was sent colonoscopy instructions and a stool blood test kit, followed by a reminder. The TNI Group received mailed screening contacts keyed to preference, and also received telephone navigation and a reminder. An endpoint survey was administered and an endpoint review of medical records was performed to determine s...

Cognitive stimulation for Portuguese older adults with cognitive impairment: a randomized controlled trial of efficacy, comparative duration, feasibility, and experiential relevance.

Although some studies point to cognitive stimulation as a beneficial therapy for older adults with cognitive impairments, this area of research and practice is still lacking dissemination and is underrepresented in many countries. Moreover, the comparative effects of different intervention durations remain to be established and, besides cognitive effects, pragmatic parameters, such as cost-effectiveness and experiential relevance to participants, are seldom explored. In this work, we present a randomized controlled wait-list trial evaluating 2 different intervention durations (standard = 17 vs brief = 11 sessions) of a cognitive stimulation program developed for older adults with cognitive impairments with or without dementia. 20 participants were randomly assigned to the standard duration intervention program (17 sessions, 1.5 months) or to a wait-list group. At postintervention of the standard intervention group, the wait-list group crossed over to receive the brief intervention program (11 sessions, 1 month). Changes in neuropsychological, functionality, quality of life, and caregiver outcomes were evaluated. Experience during intervention and costs and feasibility were also evaluated. The current cognitive stimulation programs (ie, standard and brief) showed high values of experiential relevance for both intervention durations. High adherence, completion rates, and reasonable costs were found for both formats. Further studies are needed to definitively establish the potential efficacy, optimal duration, cost-effectiveness, and experiential relevance for participants of cognitive intervention approaches.

Cost-effectiveness of a standard intervention versus a navigated intervention on colorectal cancer screening use in primary care.

Colorectal cancer (CRC) screening is cost-effective but underused. The objective of this study was to determine the cost-effectiveness of a mailed standard intervention (SI) and tailored navigation interventions (TNIs) to increase CRC screening use in the context of a randomized trial among primary care patients. Participants (n = 945) were randomized either to a usual care control group (n = 317), to an SI group (n = 316), or to a TNI group (n = 312). The SI group was sent both colonoscopy instructions and stool blood tests irrespective of baseline preference. TNI group participants were sent instructions for scheduling a colonoscopy, a stool blood test, or both based on their test preference, as determined at baseline; then, they received a navigation telephone call. Activity cost estimation was used to determine the cost of each intervention and to compute incremental cost-effectiveness ratios. Statistical uncertainty within the base case was assessed with 95% confidence intervals derived from net benefit regression analysis. The effects of uncertain parameters, such as the cost of planning, training, and involvement of those receiving "investigator salaries," were assessed with sensitivity analyses. Program costs of the SI were $167 per participant. The average cost of the TNI was $289 per participant. The TNI was more effective than the SI but substantially increased the cost per additional individual screened. Decision-makers need to consider cost structure, level of planning, and training required to implement these 2 intervention strategies and their willingness to pay for additional individuals screened to determine whether a tailored navigation would be justified and feasible.

Impact of Educational Cartoon on Pediatric Bowel Preparation Quality at Time of Colonoscopy.

Objective: To evaluate if addition of educational cartoon to pediatric bowel preparation instructions improves the quality of bowel preparation and patient experience. Methods: Patients were randomized to control group receiving standard bowel preparation instructions or intervention group receiving additional educational cartoon. To objectively rate bowel preparation, a blinded endoscopist completed numeric Ottawa score (0-14, with 0 being best). The family also completed a questionnaire rating the bowel preparation process. Results: Data from 23 patients were analyzed. Mean Ottawa score in the intervention group compared with controls was not significantly different (mean scores 3.73 and 3.33, respectively; P = .384). Level of education was significantly correlated with better Ottawa score in the overall population (ρ = −.462, P = .026) and within the control group (ρ = −.658, P = .02). Both groups of patients reported positive experience with bowel preparation. Conclusion: There may be benefit to further investigation of this educational cartoon in parents with less than college level education or non-English-speaking families in larger population of patients.

The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur: a protocol for a double-blind quasi randomised controlled trial

BackgroundMortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications. One such complication is surgical site infection (SSI), which at the start of this trial affected 4.68% of patients in the UK having this operation. Compared to SSI rates of elective hip surgery, at less than 1%, this figure is elevated. The aim of this quasi randomised controlled trial (RCT) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur.Methods848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT. Participants were recruited before surgery and quasi randomised to standard care or intervention group. Participants, statistician and outcome assessors were blind to treatment allocation throughout the study. The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin. The primary outcome is Health Protection Agency (HPA) defined deep surgical site infection at 12 months. Secondary outcomes include HPA defined superficial surgical site infection at 30 days, 30 and 90-day mortality, length of hospital stay, critical care stay, and complications.DiscussionLarge randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon, particularly in the speciality of orthopaedics. The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty. If high dose antibiotic impregnated cement is found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty.Trial registrationCurrent Controlled Trials: ISRCTN25633145

Supervised Exercise–Based Intervention to Prevent Excessive Gestational Weight Gain: A Randomized Controlled Trial

To study the effect on maternal weight gain of a supervised light- to moderate-intensity exercise-based intervention performed from the ninth week of pregnancy. A total of 962 healthy pregnant women were randomly assigned to a standard care or exercise intervention group conducted between September 1, 2007, and January 31, 2011. The intervention included light- to moderate-intensity aerobic and resistance exercises performed 3 days a week (50-55 minutes per session). Excessive gestational weight gain was calculated on the basis of the 2009 Institute of Medicine (IOM) recommendations. Gestational body weight gain was calculated on the basis of the weight measured at the first prenatal visit (fifth to sixth weeks of gestation) and weight measured at the last visit to the clinic before delivery. Women were categorized into normal weight or overweight or obese. Women in the intervention group gained less weight (adjusted mean difference, 1.039 kg; 95% CI, 0.534-1.545 kg; P<.001) and were less likely to gain weight above the IOM recommendations (odds ratio, 0.625; 95% CI, 0.461-0.847) compared with those in the standard care group. The main treatment effects according to body mass index category were that normal weight women in the intervention group gained less weight (adjusted mean difference, 1.393 kg; 95% CI, 0.813-1.972 kg; P<.001) and were less likely to gain weight above the IOM recommendations (odds ratio, 0.508; 95% CI, 0.334-0.774) than normal weight women who received standard care. No significant treatment effect was observed in overweight or obese women. Supervised exercise of light to moderate intensity can be used to prevent excessive gestational weight gain, especially in normal weight women. clinicaltrials.gov Identifier: NCT01790347.

Long-term effects of the booster-enhanced READY-Girls preconception counseling program on intentions and behaviors for family planning in teens with diabetes.

OBJECTIVETo examine 12-month effects of a booster-enhanced preconception counseling (PC) program (READY-Girls) on family planning for teen girls with type 1 and type 2 diabetes.RESEARCH DESIGN AND METHODSParticipants 13–19 years of age (n = 109) were randomized to a standard care control group (CG) or intervention group (IG) that received PC over three consecutive clinic visits. Prepost data were collected at baseline, 3- and 6-month booster sessions, and a 12-month follow-up visit.RESULTSMean age was 15.8 years; 9 (8%) subjects had type 2 diabetes; and 18 (17%) subjects were African American. At baseline, 20% (n = 22 of 109) had been sexually active, and of these, 50% (n = 11) had at least one episode of unprotected sex. Over time, IG participants retained greater PC knowledge (F[6, 541] = 4.05, P = 0.0005) and stronger intentions regarding PC (significant group-by-time effects) especially after boosters. IG participants had greater intentions to discuss PC (F[6, 82.4] = 2.56, P = 0.0254) and BC (F[6, 534] = 3.40, P = 0.0027) with health care providers (HCPs) and seek PC when planning a pregnancy (F[6, 534] = 2.58, P = 0.0180). Although not significant, IG participants, compared with CG, showed a consistent trend toward lower rates of overall sexual activity over time: less sexual debut (35 vs. 41%) and higher rates of abstinence (44 vs. 32%). No pregnancies were reported in either group throughout the study.CONCLUSIONSREADY-Girls appeared to have long-term sustaining effects on PC knowledge, beliefs, and intentions to initiate discussion with HCPs that could improve reproductive health behaviors and outcomes. Strong boosters and providing PC at each clinic visit could play important roles in sustaining long-term effects.

The effect of person-centred communication on parental stress in a NICU: a randomized clinical trial

To investigate the effect of the Guided Family-Centred Care intervention, developed by the lead author, on parental stress in a neonatal intensive care unit (NICU). Parents (n=134) of infants born ≤34weeks gestational age were randomly assigned to a standard care group (n=60) or intervention group (n=74) between April 2011 and August 2012. Guided Family-Centred Care components used were as follows: scheduled nurse-parent dialogues, semi-structured reflection sheets and person-centred communication. Parental stress was assessed at discharge using parent-reported outcomes on the Nurse Parent Support Tool and the Parental Stressor Scale: Neonatal Intensive Care Unit. The total stress scores reported by parents did not vary significantly between the intervention and standard groups, with a mean (SD) of 2.70 (0.67) versus 2.84 (0.71), respectively. However, the confidence interval included the prespecified clinical significance level. Subscale and Nurse Parent Support Tool scores did not differ between the groups. Overall, mothers reported more stress than fathers (p<0.001). Our study was unable to demonstrate the effect of person-centred communication using the Guided Family-Centred Care intervention. It may be necessary to replicate the design to address the risk of contamination and add instruments sensitive to human interaction.

Exercise therapy and custom-made insoles are effective in patients with excessive pronation and chronic foot pain—A randomized controlled trial

BackgroundExcessive foot pronation is a causal mechanisms described in relation to injuries of the lower extremities. Evidence to support an effective treatment is insufficient. ObjectiveTo investigate the effect of exercise and custom-made insoles to patients with excessive pronation and chronic pain conditions in the foot at short and long term follow-up. MethodsSingle blinded Randomized Controlled Trial with 80 subjects randomized: (1) Standard Intervention, (2) Insole, (3) Exercise, and (4) Insole+Exercise. Exercise – 12 week supervised program. Insoles – individually molded and posted. Pain was measured during walking, resting and running. Static and dynamic foot postures were measured as calcaneal angle, navicular drift, drop and height. ResultsThe average duration of foot pain was 7.3 years. There was a significant pain reduction during walking within all groups at 4 and 12 months follow-up. No differences were seen between groups in any of the pain parameters. Weak correlations between changes in pain and foot postures were observed at baseline and one-year follow-up. ConclusionA significant pain reduction was seen in all groups, none of the treatment modalities seem to be superior with the number of patients included. Compliance in the standard intervention group was a concern at 12 months.

The Added Value of a Brief Self-Efficacy Coaching on the Effectiveness of a 12-Week Physical Activity Program

Self-efficacy has been found to be an important precondition for behavioral change in sedentary people. The current study examined the effectiveness and added value of including a 15-minute self-efficacy coaching at the start of a 12-week lifestyle physical activity (PA) program. Participants were randomly assigned to a standard-intervention group (without additional self-efficacy coaching, N = 116) or extra-intervention group (with additional self-efficacy coaching, N = 111). Body mass index (BMI), cardiovascular fitness, self-reported PA, and self-efficacy beliefs were assessed at baseline and immediately after the intervention period. Perceived adherence to the PA program was assessed postintervention. At posttest, a significant increase in cardiovascular fitness and decrease in BMI were found in both groups. Significant intervention effects emerged on PA behavior, self-efficacy, and program adherence, in favor of the extra-intervention group. Self-efficacy mediated the intervention effect on program adherence whereas no evidence was found for its role as mediator of PA change. Adding a 15-minute self-efficacy coaching at the start of a lifestyle PA program is a promising strategy to enhance the intervention effects on PA behavior, self-efficacy beliefs, and program adherence. However, the role of self-efficacy as mediator of the intervention effect on in PA was not fully supported.

Mothers are not fathers: differences between parents in the reduction of stress levels after a parental intervention in a NICU

The study examined the effects of a parental intervention to reduce parents' stress levels during the hospitalization of their very preterm infants in a NICU, taking into account possible differences between mothers and fathers. Parents of infants born ≤ 32 weeks gestational age (GA) were randomly assigned to a standard support group (N = 21) or intervention group (N = 21). The intervention was based both on a joint observation method and infant massage provided by both parents. Parents' stress was assessed by the Parental Stressor Scale: Neonatal Intensive Care Unit, after the first week of admission and at the infant's discharge. At discharge, intervention group parents showed significantly lower levels of stress related to infants' appearance/behaviour and to parental role alteration (PRA) than those of the standard support group (p = 0.000). Overall, mothers reported more stress compared with fathers (p ≤ 0.05). The intervention was effective in reducing the stress-role alteration in mothers (p < 0.05), but not in fathers. Mothers reported more stress compared with fathers, above all for PRA. A parental intervention was effective in reducing stress-role alteration in mothers, but not fathers. Parental interventions should take into account that help for fathers could be different from help for mothers.

Preoperative Nutritional Interventions in Morbid Obesity: Impact on Body Weight, Energy Intake, and Eating Quality

Although the benefits of preoperative weight loss and adequacy of dietary patterns in bariatric surgery is well-recognized, the nutritional strategies in the preoperative period have been scarcely investigated. We aimed to evaluate the impact of intensive and standard nutritional interventions on body weight, energy intake, and eating quality. This is a retrospective study in which 32 patients undergoing intensive nutritional intervention, with low-calorie diet (10 kcal/kg) and biweekly visits, were pair-matched by age, sex, and body mass index with 32 patients under a standard nutritional intervention, based on a general dietary counseling. Twenty-four-hour food recall was used to assess energy intake and to derive healthy eating index (HEI). The follow-up preoperative period varied from 8 to 16 weeks. Weight loss was observed in 72% of the patients from the intensive intervention group and 75% of the patients from the standard intervention group. According to the mixed model analysis, time effect on weight loss in both groups was significant (P = 0.0002); however, no difference was found between the intervention groups (P = 0.71). The time effect was significant in both groups for energy intake reduction as well (P < 0.0001), but no difference was found between the intervention groups (P = 0.25). Improvement of eating quality was expressed by the nutrient score of the HEI that increased significantly overtime (P = 0.02), also without distinction between the groups (P = 0.61). Both intensive and standard nutritional interventions promoted weight loss, energy intake reduction, and improvement of eating quality in morbidly obese patients during preoperative period.

Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention

To assess the feasibility and effectiveness of an active real-life primary care lifestyle intervention in preventing type 2 diabetes within a high-risk Mediterranean population. A prospective cohort study was performed in the setting of Spanish primary care. White-European individuals without diabetes aged 45-75 years (n = 2,054) were screened using the Finnish Diabetes Risk Score (FINDRISC) and a subsequent 2 h OGTT. Where feasible, high-risk individuals who were identified were allocated sequentially to standard care, a group-based or an individual level intervention (intensive reinforced DE-PLAN [Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional] intervention). The primary outcome was the development of diabetes according to WHO criteria. Analyses after 4-year follow-up were performed based on the intention-to-treat principle with comparison of standard care and the combined intervention groups. The standard care (n = 219) and intensive intervention (n = 333) groups were comparable in age (62.0/62.2 years), sex (64.4/68.2% women), BMI (31.3/31.2 kg/m(2)), FINDRISC score (16.2/15.8 points), fasting (5.3/5.2 mmol/l), 2 h plasma glucose (7.1/6.9 mmol/l) and self-reported interest to make lifestyle changes at baseline. Diabetes was diagnosed in 124 individuals: 63 (28.8%) in the standard care group and 61 (18.3%) in the intensive intervention group. During a 4.2-year median follow-up, the incidences of diabetes were 7.2 and 4.6 cases per 100 person-years, respectively (36.5% relative risk reduction, p < 0.005). The number of participants needed to be treated by intensive intervention for 4 years to reduce one case of diabetes was 9.5. Intensive lifestyle intervention is feasible in a primary care setting and substantially reduces diabetes incidence among high-risk individuals. ClinicalTrial.gov NCT01519505. Commission of the European Communities, Institute of Health Carlos III, Spanish Ministry of Health and Department of Health, Generalitat de Catalunya.

An assessment of brief group interventions to increase condom use by heterosexual crack smokers living with HIV infection

The purpose of this study was to assess the efficacy of brief group interventions, the positive choices intervention (PCI) and a standard intervention (SI), to increase condom use and intention to use condoms and to change condom use attitudes and beliefs. The design of the study was a randomized comparative trial. Participants were 347 heterosexual African American crack cocaine users living with HIV infection. Data were collected at intake and at three and nine months after intake. Behavioral and sociocognitive data were collected. Although both brief interventions achieved positive results, there were significant differences in outcomes between the interventions groups. The mean number of sex partners was significantly lower in the PCI group at three months. The proportion of those assigned to the PCI reporting sex with a paid partner significantly decreased, while the proportion disclosing their serostatus to their partners increased. There were no significant differences on these measures in the SI group. Significant time effects were found on measures of condom use, condom use attitudes, and self-efficacy beliefs. These measures significantly increased from intake to one month for both groups. One significant time-by-group effect was found. The measure of situational self-efficacy significantly increased in the PCI group, but not the SI group. Results also showed significant time-by-time effects. Mean condom use, intention to use condoms, attitudes, and condom use self-efficacy beliefs showed significant difference between three and nine months. However, there was no clear pattern of change. Findings suggest that brief group interventions designed to reduce HIV can help heterosexual drug users living with HIV infection increase condom use and intention to use condoms and change condom use attitudes and beliefs. A significant time-by-group effect was observed only for situational self-efficacy, suggesting limited additional efficacy of the PCI intervention. Given similar positive findings between groups, more research is needed to determine which components of brief interventions produce changes in motivations and risk behaviors.

Supplemental oxygen for the prevention of postcesarean infectious morbidity: a randomized controlled trial

The purpose of this study was to investigate whether supplemental oxygen during and for 2 hours after cesarean delivery reduces the incidence of postcesarean infectious morbidity. We conducted a randomized, controlled trial from 2008-2010. Women who underwent cesarean delivery were randomly assigned to receive either 2 L of oxygen by nasal cannula during cesarean delivery only (standard care) or 10 L of oxygen by nonrebreather mask (intervention group) during and for 2 hours after cesarean delivery. Women who underwent scheduled or intrapartum cesarean delivery were eligible and were observed for 1 month after the procedure. The primary composite outcome was maternal infectious morbidity, which included endometritis and wound infection. Five hundred eighty-five women were included in the final analysis. Infectious morbidity occurred in 8.8% of patients in the standard care group and in 12.2% of patients in the supplemental oxygen group. There was no significant difference in the rate of infectious morbidity between the standard care and intervention groups (relative risk, 1.4; 95% confidence interval, 0.9-2.3). Supplemental oxygen does not reduce the rate of postcesarean delivery infectious morbidity, including endometritis and wound infection.