scholarly journals Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Craig R. Cohen ◽  
Su-Chun Cheng ◽  
Stephen Shiboski ◽  
Tsungai Chipato ◽  
Martin Matu ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vaginal Swab ◽  
Intention To Treat ◽  
Hiv Acquisition ◽  
And Control ◽  
Treat Analysis

Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial.Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

scholarly journals Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Manual Therapy ◽  
Joint Pain ◽  
Controlled Trial ◽  
Control Group ◽  
Load Bearing ◽  
Intention To Treat ◽  
Joint Health ◽  
Experimental Group ◽  
Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

scholarly journals Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial

Endoscopy ◽  
2020 ◽  
Vol 52 (11) ◽  
pp. 1026-1035 ◽  
Author(s):  
Marco Antonio Alvarez-Gonzalez ◽  
Miguel Ángel Pantaleón Sánchez ◽  
Belén Bernad Cabredo ◽  
Ana García-Rodríguez ◽  
Santiago Frago Larramona ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Telephone Intervention ◽  
Intention To Treat ◽  
Bowel Cleansing ◽  
Significant Difference ◽  
Inadequate Bowel Preparation ◽  
And Control

Background The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy. Methods We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases. Results 657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %; P = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %; P = 0.001). Conclusion Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.

scholarly journals The effectiveness of the Volunteer Family Connect Program in supporting vulnerable families: A randomised controlled trial intention-to-treat analysis of primary outcome variables (Preprint)

2018 ◽  
Author(s):  
Rebekah Grace ◽  
Kelly Baird ◽  
Emma Elcombe ◽  
Vana Webster ◽  
Jacqueline Barnes ◽  
...  
Keyword(s):  
Young Children ◽  
Home Visiting ◽  
Controlled Trial ◽  
Intervention Group ◽  
Parenting Competence ◽  
Community Connectedness ◽  
Intention To Treat ◽  
Vulnerable Families ◽  
Secondary Outcomes ◽  
Treat Analysis

BACKGROUND Volunteer home visiting is a widely adopted community-based approach to supporting families by linking isolated or vulnerable families with community volunteers. This study seeks to robustly evaluate the effectiveness of this model of support for families with young children. OBJECTIVE This paper reports the intention-to-treat analysis of primary and secondary outcomes for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families with young children who experience social isolation or a lack of parenting confidence and skills. METHODS The RCT was conducted across seven sites in Australia. Overall, 341 families were recruited: 169 intervention (services as usual + volunteer home visiting) and 172 control (services as usual) families. Intervention families received the program for 3-12 months. Participants were invited to complete six data collection points over a 15-month period. Primary outcomes were community connectedness and parenting competence. Secondary outcomes included parent physical and mental health, general parent wellbeing, parent empowerment, the sustainability of family routines, and the parent-child relationship. RESULTS The intervention group demonstrated significant improvement compared to the control group in both of the primary outcomes. They were significantly more like to report improvements in the guidance available to them as measured by the Social Provisions Scale, a key measure of community connectedness and scores on the Parenting Sense of Competence Scale were significantly in favour of the intervention group. Intervention families also reported significantly higher wellbeing, and were significantly more likely to feel that life was improving. A number of positive trends were also evident within the findings. CONCLUSIONS The Volunteer Family Connect intervention was considered to be an effective intervention for improving the community connectedness and parenting competence of families with young children. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN12616000396426).

scholarly journals A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Ellen Kemler ◽  
Vincent Gouttebarge
Keyword(s):  
Randomized Controlled Trial ◽  
Injury Prevention ◽  
Preventive Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Prevention Measures ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
And Control

BACKGROUND Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. CLINICALTRIAL Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv) INTERNATIONAL REGISTERED REPOR RR1-10.2196/9708

scholarly journals Randomised controlled trial with economic and process evaluations of domiciliary welfare rights advice for socioeconomically disadvantaged older people recruited via primary health care (the Do-Well study)

2019 ◽  
Vol 7 (3) ◽  
pp. 1-228
Author(s):  
Catherine Haighton ◽  
Suzanne Moffatt ◽  
Denise Howel ◽  
Mel Steer ◽  
Frauke Becker ◽  
...  
Keyword(s):  
Older People ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Welfare Rights ◽  
North East ◽  
And Control

BackgroundWelfare rights advice services are effective at maximising previously unclaimed welfare benefits, but their impact on health has not been evaluated.ObjectiveTo establish the acceptability, cost-effectiveness and effect on health of a domiciliary welfare rights advice service targeting older people, compared with usual practice.DesignA pragmatic, individually randomised, parallel-group, single-blinded, wait-list controlled trial, with economic and process evaluations. Data were collected by interview at baseline and 24 months, and by self-completion questionnaire at 12 months. Qualitative interviews were undertaken with purposive samples of 50 trial participants and 17 professionals to explore the intervention’s acceptability and its perceived impacts.SettingParticipants’ homes in North East England, UK.ParticipantsA total of 755 volunteers aged ≥ 60 years, living in their own homes, fluent in English and not terminally ill, recruited from the registers of 17 general practices with an Index of Multiple Deprivation within the most deprived two-fifths of the distribution for England, and with no previous access to welfare rights advice services.InterventionsWelfare rights advice, comprising face-to-face consultations, active assistance with benefit claims and follow-up as required until no longer needed, delivered in participants’ own homes by a qualified welfare rights advisor. Control group participants received usual care until the 24-month follow-up, after which they received the intervention.Main outcome measuresThe primary outcome was health-related quality of life (HRQoL), assessed using the CASP-19 (Control, Autonomy, Self-realisation and Pleasure) score. The secondary outcomes included general health status, health behaviours, independence and hours per week of care, mortality and changes in financial status.ResultsA total of 755 out of 3912 (19%) general practice patients agreed to participate and were randomised (intervention,n = 381; control,n = 374). In the intervention group, 335 participants (88%) received the intervention. A total of 605 (80%) participants completed the 12-month follow-up and 562 (75%) completed the 24-month follow-up. Only 84 (22%) intervention group participants were awarded additional benefits. There was no significant difference in CASP-19 score between the intervention and control groups at 24 months [adjusted mean difference 0.3, 95% confidence interval (CI) –0.8 to 1.5], but a significant increase in hours of home care per week in the intervention group (adjusted difference 26.3 hours/week, 95% CI 0.8 to 56.1 hours/week). Exploratory analyses found a weak positive correlation between CASP-19 score and the amount of time since receipt of the benefit (0.39, 95% CI 0.16 to 0.58). The qualitative data suggest that the intervention was acceptable and that receipt of additional benefits was perceived by participants and professionals as having had a positive impact on health and quality of life. The mean cost was £44 per participant, the incremental mean health gain was 0.009 quality-adjusted life-years (QALYs) (95% CI –0.038 to 0.055 QALYs) and the incremental cost-effectiveness ratio was £1914 per QALY gained.ConclusionsThe trial did not provide sufficient evidence to support domiciliary welfare rights advice as a means of promoting health among older people, but it yielded qualitative findings that suggest important impacts on HRQoL. The intervention needs to be better targeted to those most likely to benefit.Future workFurther follow-up of the trial could identify whether or not outcomes diverge among intervention and control groups over time. Research is needed to better understand how to target welfare rights advice to those most in need.Trial registrationCurrent Controlled Trials ISRCTN37380518.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 7, No. 3. See the NIHR Journals Library website for further project information. The authors also received a grant of £28,000 from the North East Strategic Health Authority in 2012 to cover the costs of intervention delivery and training as well as other non-research costs of the study.

Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes

2009 ◽  
Vol 15 (3) ◽  
pp. 125-128 ◽  
Author(s):  
Robert SH Istepanian ◽  
Karima Zitouni ◽  
Diane Harry ◽  
Niva Moutosammy ◽  
Ala Sungoor ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Controlled Trial ◽  
Group Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Technical Problems ◽  
Intention To Treat ◽  
Patients With Diabetes ◽  
And Control

We conducted a randomized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes. Patients in the intervention group ( n = 72) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link. Clinicians were then able to examine and respond to the readings which were viewed with a web-based application. Patients in the control arm of the study ( n = 65) did not transmit their readings and received care with their usual doctor in the outpatient and/or primary care setting. The mean follow-up period was 9 months in each group. The default rate was higher in the patients in the intervention arm due to technical problems. In an intention-to-treat analysis there were no differences in HbA1c between the intervention and control groups. In a sub-group analysis of the patients who completed the study, the telemonitoring group had a lower HbA1c than those in the control group: 7.76% and 8.40%, respectively ( P = 0.06).

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