Trials Of Health Interventions Research Articles

(196) Implications for assessments with the treatment as usual condition within comparative effectiveness research with an underserved population

Addressing health disparities has become a major focus in research, policy, and practice especially for a patient population burdened with additional psychosocial factors that may negatively impact health outcomes. As with pain management, communities with limited resources may not be equipped to fulfill the pain management needs of their patients. In an ongoing randomized-comparative effectiveness trial of behavioral health interventions for chronic pain, participants in the treatment as usual (TAU) comparison groups are assessed alongside participants who have been randomized to either a cognitive-behavioral coping skills or pain education group.

Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries.

People living with HIV (PLWH) experience greater psychological distress than the general population. Evidence from high-incomes countries suggests that psychological interventions for PLWH can improve mental health symptoms, quality of life, and HIV care engagement. However, little is known about the effectiveness of mental health interventions for PLWH in low and middle-income countries (LMICs), where the large majority of PLWH reside. This systematized review aims to synthesize findings from mental health intervention trials with PLWH in LMICs to inform the delivery of mental health services in these settings. A systematic search strategy was undertaken to identify peer-reviewed published papers of intervention trials addressing negative psychological states or disorders (e.g., depression, anxiety) among PLWH in LMIC settings. Search results were assessed against pre-established inclusion and exclusion criteria. Data from papers meeting criteria were extracted for synthesis. Twenty-six papers, published between 2000 and 2014, describing 22 unique interventions were identified. Trials were implemented in sub-Saharan Africa (n=13), Asia (n=7), and the Middle East (n=2), and addressed mental health using a variety of approaches, including cognitive-behavioral (n=18), family-level (n=2), and pharmacological (n=2) treatments. Four randomized controlled trials reported significant intervention effects in mental health outcomes, and eleven preliminary studies demonstrated promising findings. Among the limited mental health intervention trials with PLWH in LMICs, few demonstrated efficacy. Mental health interventions for PLWH in LMICs must be further developed and adapted for resource-limited settings to improve effectiveness.

A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan, Northern Iraq.

BackgroundExperiencing systematic violence and trauma increases the risk of poor mental health outcomes; few interventions for these types of exposures have been evaluated in low resource contexts. The objective of this randomized controlled trial was to assess the effectiveness of two psychotherapeutic interventions, Behavioral Activation Treatment for Depression (BATD) and Cognitive Processing Therapy (CPT), in reducing depression symptoms using a locally adapted and validated version of the Hopkins Symptom Checklist and dysfunction measured with a locally developed scale. Secondary outcomes included posttraumatic stress, anxiety, and traumatic grief symptoms.MethodsTwenty community mental health workers, working in rural health clinics, were randomly assigned to training in one of the two interventions. The community mental health workers conducted baseline assessments, enrolled survivors of systematic violence based on severity of depression symptoms, and randomly assigned them to treatment or waitlist-control. Blinded community mental health workers conducted post-intervention assessments on average five months later.ResultsAdult survivors of systematic violence were screened (N = 732) with 281 enrolled in the trial; 215 randomized to an intervention (114 to BATD; 101 to CPT) and 66 to waitlist-control (33 to BATD; 33 to CPT). Nearly 70% (n = 149) of the intervention participants completed treatment and post-intervention assessments; 53 (80%) waitlist-controls completed post-intervention assessments. Estimated effect sizes for depression and dysfunction were 0.60 and 0.55 respectively, comparing BATD participants to all controls and 0.84 and 0.79 respectively, compared to BATD controls only. Estimated effect sizes for depression and dysfunction were 0.70 and 0.90 respectively comparing CPT participants to all controls and 0.44 and 0.63 respectively compared to CPT controls only. Using a permutation-based hypothesis test that is robust to the model assumptions implicit in regression models, BATD had significant effects on depression (p = .003) and dysfunction (p = .007), while CPT had a significant effect on dysfunction only (p = .004).ConclusionsBoth interventions showed moderate to strong effects on most outcomes. This study demonstrates effectiveness of these interventions in low resource environments by mental health workers with limited prior experience.Trial RegistrationClinicalTrials.Gov NCT00925262. Registered June 3, 2009.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-014-0360-2) contains supplementary material, which is available to authorized users.

How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes

Objective: Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes.Design: We conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression.Main outcome measures: Standard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes.Results: We identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly.Conclusion: The quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.

Are Older Adults Missing From Low Back Pain Clinical Trials? A Systematic Review and Meta‐Analysis

There is evidence to suggest that older adults are underrepresented in randomized controlled trials of health interventions. The aim of this review was to systematically examine the age-related inclusion criteria distribution of participants in randomized controlled trials (RCTs) of low back pain (LBP) interventions and to investigate if this distribution pattern changes over time. We identified, in PubMed, 1,047 RCTs on nonspecific LBP published since 1992, of which a random sample of 400 was assessed for inclusion in the review. Included studies were grouped according to treatment type. Data were extracted on year of publication, types of treatment, total number of participants, age inclusion criteria, and age of included participants. A total of 274 RCTs published between 1992 and 2010 met the inclusion criteria. A total of 41.6% (n = 114) of the included trials excluded people ages >65 years. The pooled mean age of participants was 44.3 years (95% confidence interval 42.4-46.3); the pooled minimum age for inclusion was 19.8 years and the pooled maximum age for inclusion was 65.4 years. We found no trend of including older participants in RCTs on LBP over time. Despite an aging population around the globe, older adults are largely excluded from RCTs evaluating management of LBP, and there is no evidence of change in this practice over the last 2 decades.

Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

BackgroundQualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice.MethodsA telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research.ResultsInterviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research.ConclusionsHealth researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.

Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews, three models of study were identified: qualitative research as peripheral to the trial, qualitative research as an 'add-on' to the trial and a study with qualitative research and trial as essential components, with the third model offering more opportunity to maximise the value of the qualitative research. Interviewees valued the use of qualitative research with trials and identified team structures and wider structural issues which gave more value to the trial than the qualitative research as barriers to maximising the value of the qualitative research. A large number of articles were published between 2008 and 2010, addressing a wide range of aspects of trials. There were examples of this research affecting the trial by facilitating interpretation of trial findings, developing and refining interventions for testing in the trial and changing the measures used in the trial. However, researchers were not necessarily maximising the value of qualitative research undertaken with trials to the endeavour of generating evidence of effectiveness of health interventions. Researchers can maximise value by promoting its use at the pre-trial stage to ensure that the intervention and trial conduct is optimised at the main trial stage, being explicit about the conclusions for the trial endeavour in peer-reviewed journal articles reporting the qualitative research and valuing the contribution of the qualitative research as much as the trial. Future recommendations for researchers include: plan the qualitative research, design and implement studies not trials, use qualitative research at the feasibility and pilot stage of trials, be explicit in publications about the impact of the qualitative research on the trial and implications for the trial endeavour, undertake in-depth qualitative research, allow qualitative research to take a challenging role and develop a learning environment around the use of qualitative research and trials. This project was funded by the Medical Research Council (MRC) as part of the MRC-National Institute for Health Research Methodology Research programme.

Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers

Background Community-based cluster-randomized controlled trials (RCTs) are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster) RCTs of population health interventions in low- and middle-income countries. Objective We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships. Design We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB) and Human Immunodeficiency Virus (HIV) prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies. Results The checklist of critical factors was grouped into eight categories: 1) Building trust and shared ownership; 2) Conducting feasibility studies throughout the process; 3) Building capacity; 4) Creating an appropriate information system; 5) Conducting pilot studies; 6) Securing stakeholder support, with a view to scale-up; 7) Continuously refining methodological rigor; and 8) Explicitly addressing all ethical issues both at the start and continuously as they arise. Conclusion Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.

Changes in Sexual Behavior of HIV-Infected Older Adults Enrolled in a Clinical Trial of Standalone Group Psychotherapies Targeting Depression

By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30 % of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults.

Collecting and analysing cost data for complex public health trials: reflections on practice

BackgroundCurrent guidelines for the conduct of cost-effectiveness analysis (CEA) are mainly applicable to facility-based interventions in high-income settings. Differences in the unit of analysis and the high cost of data collection can make these guidelines challenging to follow within public health trials in low- and middle- income settings.ObjectiveThis paper reflects on the challenges experienced within our own work and proposes solutions that may be useful to others attempting to collect, analyse, and compare cost data between public health research sites in low- and middle-income countries.DesignWe describe the generally accepted methods (norms) for collecting and analysing cost data in a single-site trial from the provider perspective. We then describe our own experience applying these methods within eight comparable cluster randomised, controlled, trials. We describe the strategies used to maximise adherence to the norm, highlight ways in which we deviated from the norm, and reflect on the learning and limitations that resulted.ResultsWhen the expenses incurred by a number of small research sites are used to estimate the cost-effectiveness of delivering an intervention on a national scale, then deciding which expenses constitute ‘start-up’ costs will be a nontrivial decision that may differ among sites. Similarly, the decision to include or exclude research or monitoring and evaluation costs can have a significant impact on the findings. We separated out research costs and argued that monitoring and evaluation costs should be reported as part of the total trial cost. The human resource constraints that we experienced are also likely to be common to other trials. As we did not have an economist in each site, we collaborated with key personnel at each site who were trained to use a standardised cost collection tool. This approach both accommodated our resource constraints and served as a knowledge sharing and capacity building process within the research teams.ConclusionsGiven the practical reality of conducting randomised, controlled trials of public health interventions in low- and middle- income countries, it is not always possible to adhere to prescribed guidelines for the analysis of cost effectiveness. Compromises are frequently required as researchers seek a pragmatic balance between rigor and feasibility. There is no single solution to this tension but researchers are encouraged to be mindful of the limitations that accompany compromise, whilst being reassured that meaningful analyses can still be conducted with the resulting data.

The effectiveness of sexual health interventions for people with severe mental illness: a systematic review

Severe mental illnesses (SMIs), such as schizophrenia and bipolar disorder, persist over time and can cause extensive disability leading to impairments in social and occupational functioning. People with SMI have higher morbidity and mortality due to physical illness than the general population and may be more likely to engage in high-risk sexual behaviour (e.g. unprotected intercourse, having multiple partners, involvement in the sex trade and illicit drug use), putting them at risk of poorer sexual health outcomes including sexually transmitted infections. Sexual health promotion interventions, developed and implemented for people with SMI, may improve participants' knowledge, attitudes, beliefs or behavioural practices and could lead to a reduction in risky sexual behaviour. To evaluate the effectiveness of sexual health interventions for people with SMI compared with usual care and their applicability to the UK NHS setting. Thirteen electronic databases were searched from inception to December 2012. All controlled trials (randomised or non-randomised) that met the following criteria were included: any sexual health promotion intervention or combination of interventions intended to change the knowledge, attitudes, beliefs, behaviours or practices of individuals with SMI (defined as adults aged ≥ 18 years who have received a diagnosis of schizophrenia or bipolar disorder) living in the community. A systematic review of the clinical evidence was undertaken following recommended guidelines. Data were tabulated and discussed in a narrative review. Thirteen randomised controlled studies met the inclusion criteria. The methodological quality of the included studies varied considerably, with only a minority of studies (n = 2) being considered as having very few methodological limitations. Despite wide variations in the study populations, interventions, comparators and outcomes, four studies showed significant improvements in all measured sexual risk behaviour outcomes (e.g. human immunodeficiency virus knowledge and behaviour change) in the intervention groups compared with the control groups. In contrast, four studies found significant improvements in the intervention groups for some outcomes only and three studies found significant improvements in certain subgroups only, based on either gender or ethnicity. Finally, two studies reported no significant differences in any sexual risk behaviour outcomes between the intervention and control groups. Moreover, positive findings were not consistently sustained at follow-up in many studies. Little detail was provided in the studies regarding the content of interventions, how they were delivered and by whom, making replication or generalisability difficult. Owing to the large between-study variability (especially in the populations, interventions, comparators and reported outcomes) and mixed results, there is insufficient evidence to fully support or reject the identified sexual health interventions for people with SMI. In addition, there are considerable uncertainties around the generalisability of these findings to the UK setting. Further research recommendations include well-designed, UK-based trials of sexual health interventions for people with SMI as well as training and support for staff implementing sexual health interventions. PROSPERO number CRD42013003674. The National Institute for Health Research Health Technology Assessment Programme.

Clinical trials in Ghana: evolution and current landscape

A review of published clinical trials from Ghana shows the earliest trials initiated in the 1970s, were mainly trials of interventions against onchocerciasis and childhood Burkitt’s lymphoma. Subsequent trials in the 1980s and 1990s were more diverse, comprising of preventive as well as therapeutic interventions against major communicable diseases of the period. In more recent times, trials of interventions against malaria have since 2000, been the most dominant and have included some of the most recently developed vaccines. There has, since the early days of clinical trial history in Ghana, been a consistent presence of trials of reproductive health interventions and surgically-related trials. There have been few trials of tuberculosis, or neonatal-related interventions, and trials against major non-communicable diseases such as hypertension, cardiovascular diseases, and mental health disorders have been virtually non-existent. The clinical trial evolution in Ghana has reflected global health initiatives and external funding exigencies and there is an urgent need for trials that are dynamic and directed towards addressing other significant and especially non-communicable disease causes of morbidity and mortality in Ghana.

Participating in online mental health interventions: who is most likely to sign up and why?

Internet-based interventions are increasingly recognized as effective in the treatment and prevention of mental disorders. However, little research has investigated who is most likely to participate in intervention trials. This study examined the characteristics of individuals interested in participating in an online intervention to improve emotional well-being and prevent or reduce the symptoms of depression, factors reported to encourage or discourage participation, and preferences for different intervention types. The study comprised 4761 Australians participating in a survey on emotional health. Comparisons are made between those who expressed an interest in participating in the trial and those who were not. Compared to those who declined to participate, interested participants were more likely older, females, separated/divorced, and highly educated, have reported current or past history of depression, report higher depressive symptoms, and have low personal stigma. Despite the flexibility of online interventions, finding time to participate was the major barrier to engagement. Financial compensation was the most commonly suggested strategy for encouraging participation. An increased understanding of factors associated with nonparticipation may inform the design of future e-mental health intervention trials. Importantly, consideration needs to be given to the competing time pressures of potential participants, in balance with the desired study design.

Public health economics of body and mind: a health economist's perspective

BackgroundIf public health is the science and art of how society collectively aims to improve health, and reduce inequalities in health, then public health economics is the science and art of how we choose to do this with limited resources. The spectrum of public health activities is broad; for example, environmental policy, infectious disease control, individual behaviour change, and informing government legislation. I draw together key methodological considerations for the design, undertaking, and analysis of economic assessment alongside trials of public health interventions spanning environmental change and behaviour change relating to the body and mind. The discipline of health economics has grown up alongside a medical model of health. Many public health practitioners and health economists interested in public health are realising that emphasis is shifting from traditional behaviour-change interventions towards interventions that aim to change physical environments and social norms and that might need government legislation. This shift means that health economists need to approach the economic assessment of the broad spectrum of public health interventions in a more creative way. Quality-adjusted life-years may not fully capture diverse benefits of public health interventions but are useful for benchmarking the cost effectiveness of public health against clinical services. Health economists who have focussed on notions of efficiency need now to think more about equity, in view of public health goals of reducing inequalities in health. The aim is to convey to a public health science audience the challenges and opportunities facing health economists interested in public health today. MethodsI show these challenges and suggest solutions by drawing on recent published and ongoing trials of public health interventions with a health economics component. Changing the environment was investigated in the CHARISMA trial by improvement of heating and ventilation in homes of children with asthma. Changing individual physical behaviour was investigated by assessment of a national exercise referral scheme in the NERS trial. Changing individual mental behaviour was assessed by bringing mindfulness into the workplace in the Gwynedd trial. FindingsEmerging lessons include (1) the need to think about how evidence of cost effectiveness is going to be used by government and local commissioners of services, within what time horizon, and what the expected interplay may be between stakeholders; (2) mounting evidence that the government needs to focus on altering physical environments (eg, local planning laws, speed limits) and social environments (eg, school and workplace culture); and (3) a readiness to recognise where behaviour change has proved successful in the commercial sector, delivered in groups or online (eg, Slimming World). These three examples of economic analysis highlight thinking on design of economic assessment, power calculation issues relating to economic analysis, micro-costing techniques, and choice and range of outcome measures. InterpretationFaced with real public health challenges, we are beginning to learn how to design, undertake, and analyse economic assessments of public health interventions. We are learning how to provide clear evidence-based information to policy makers. Concrete recommendations to ensure funding streams for health economists, such as through the public health research programme, will help to support a methodological advancement in this field. FundingPublic Health Wales.

Sample size calculation in trials of public health interventions: a discussion of implications for health economists

BackgroundStatistical analysis enables ascertainment of whether or not there are interesting differences in effects between two or more groups and allows inferences to be made about the population from which a sample comes. For those of us interested in these differences, to be able to report on their statistical significance is useful to help us remark on the confidence we have in our results. However, careful consideration should be given to the choice of sample size. We investigated recent developments in the methodological considerations surrounding issues of identification of an appropriate sample size for a study, investigating first the issue in the context of clinical trials before going on to discuss the issue in terms of public health. MethodsIn this discussion piece, we highlight recent developments in the area of sample size calculation. We then offer two case studies that provide examples of sample size estimation under different scenarios: when no power or sample size calculations have been mentioned and when power or sample size calculations have been done properly. The first was done by the UK prospective diabetes study group (1998) in which the sample size was 1148, although there was no explicit mention of how this sample size was calculated. The second case study was an example by Briggs and Gray (1998) on the study of intracranial aneurysms. They plotted the sample size requirements as a function of the maximum cost-effectiveness ratio. One can then, for a given level of cost effectiveness, work out the sample size needed for different levels of power. FindingsAlthough clinical trials calculate sample sizes on the basis of clinical outcomes, we show that these sample sizes might not provide enough power for any economic assessment we might want to undertake, because economic assessments deal with both costs and treatment effects. Usually, economic assessment relates to estimation rather than hypothesis testing. Therefore, calculations of power and sample size in economic assessment are done in relation to some value of maximum willingness to pay (WTP) for a unit of treatment effect. The upper confidence limit of the incremental cost-effectiveness ratio of a cost-effective treatment must fall below the value of the maximum WTP and the sample size must provide enough power for this to be possible. Further, in economic assessment of public health interventions, the effective sample size might be less than the actual sample size used because of intra-cluster correlation and so the sample size must be corrected for this factor. InterpretationWe argue that a systematic review of the published work is needed to highlight the state of play with regard to sample size estimation, especially in economic assessment of public health interventions. By methodically collating the available evidence, the case for best practice in choosing the appropriate sample size can be put forward and progress can be made in increasing the number of studies that are sufficiently powered. FundingNone.

Process evaluation of Healthy Bodies, Healthy Souls: a church-based health intervention program in Baltimore City

Soaring obesity rates in the United States demand comprehensive health intervention strategies that simultaneously address dietary patterns, physical activity, psychosocial factors and the food environment. Healthy Bodies, Healthy Souls (HBHS) is a church-based, community-participatory, cluster-randomized health intervention trial conducted in Baltimore City to reduce diabetes risk among urban African Americans by promoting healthy dietary intake, increased physical activity and improvement to the church food environment. HBHS was organized into five 3-8-week phases: Healthy Beverages, Healthy Desserts, Healthy Cooking, Healthy Snacking and Eating Out and Physical Activity. A three-part process evaluation was adopted to evaluate implementation success: an in-church instrument to assess the reach, dose delivered and fidelity of interactive sessions; a post-intervention exposure survey to assess individual-level dose received in a sample of congregants and an evaluation form to assess the church food environment. Print materials were implemented with moderate to high fidelity and high dose. Program reach was low, which may reflect inaccuracies in church attendance rather than study implementation issues. Intervention components with the greatest dose received were giveaways (42.0-61.7%), followed by taste tests (48.7-53.7%) and posters (34.3-65.0%). The dose received of general program information was moderate to high. The results indicate successful implementation of the HBHS program.

Internet-Based Recruitment to a Depression Prevention Intervention: Lessons From the Mood Memos Study

BackgroundRecruiting participants to randomized controlled trials of health interventions can be very difficult. Internet-based recruitment is becoming an increasingly important mode of recruitment, yet there are few detailed accounts of experiences recruiting participants to mental health interventions.ObjectiveTo report on our experience with Internet-based recruitment to an online depression prevention intervention and pass on lessons we learned.MethodsParticipants were recruited to the Mood Memos study, an online preventive depression intervention, purely through Internet-based sources. The study was targeted to adults with subthreshold depression symptoms from several English-speaking countries. A variety of online recruitment sources were trialed, including search engine advertising (Google, Yahoo!, Bing), Facebook advertising, posts in forums and online noticeboards, and promotion through relevant websites and email newsletters of mental health organizations.ResultsThe study website received visits from 94,808 individuals over the 14-month recruitment period. The recruitment target was reached with 1699 individuals signing up to the randomized controlled trial and 1326 fully enrolling. Most visitors arrived via Google advertising, which promoted a depression-screening questionnaire. Google advertising accounted for nearly half of the total participants who signed up to the study, at an average cost of AUD $12 per participant. Promoting the study through trustworthy organizations and websites known to participants was also effective. Recruitment techniques that were less effective were contacting forums, email groups, and community noticeboards.ConclusionsSeveral techniques, including Google advertising, were successful in recruiting participants to a trial evaluating an online depression intervention. Results suggest that Internet-based recruitment to mental health interventions is feasible and can be relatively affordable.Trial RegistrationACTRN12609000925246

The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review.

Mobile technologies could be a powerful media for providing individual level support to health care consumers. We conducted a systematic review to assess the effectiveness of mobile technology interventions delivered to health care consumers. We searched for all controlled trials of mobile technology-based health interventions delivered to health care consumers using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990-Sept 2010). Two authors extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and used random effects meta-analysis. We identified 75 trials. Fifty-nine trials investigated the use of mobile technologies to improve disease management and 26 trials investigated their use to change health behaviours. Nearly all trials were conducted in high-income countries. Four trials had a low risk of bias. Two trials of disease management had low risk of bias; in one, antiretroviral (ART) adherence, use of text messages reduced high viral load (>400 copies), with a relative risk (RR) of 0.85 (95% CI 0.72-0.99), but no statistically significant benefit on mortality (RR 0.79 [95% CI 0.47-1.32]). In a second, a PDA based intervention increased scores for perceived self care agency in lung transplant patients. Two trials of health behaviour management had low risk of bias. The pooled effect of text messaging smoking cessation support on biochemically verified smoking cessation was (RR 2.16 [95% CI 1.77-2.62]). Interventions for other conditions showed suggestive benefits in some cases, but the results were not consistent. No evidence of publication bias was demonstrated on visual or statistical examination of the funnel plots for either disease management or health behaviours. To address the limitation of the older search, we also reviewed more recent literature. Text messaging interventions increased adherence to ART and smoking cessation and should be considered for inclusion in services. Although there is suggestive evidence of benefit in some other areas, high quality adequately powered trials of optimised interventions are required to evaluate effects on objective outcomes.

Psychological flexibility, occupational burnout and eating behavior among working women

Background: Occupational burnout is associated with diminished psychological flexibility and higher emotional (EE) and uncontrolled eating (UE). Psychological flexibility could be a mediating factor between burnout and eating behaviour. Objectives: To investigate differences in eating behaviour between those with different levels of psychological flexibility, and the association of the interaction between psychological flexibility and occupational burnout with eating behaviour. Design: The participants were working women (n = 263), who took part in the randomized controlled health intervention trial. Analyses were performed in a cross-sectional setting at baseline. Methods: Eating behaviour was measured using the Three Factor Eating Behaviour Questionnaire-18 [which evaluates EE, UE and cognitive restraint (CR)], psychological flexibility using Acceptance and Action Questionnaire-II and occupational burnout using Bergen Burnout Indicator-15. Participants were divided into four groups based on the quartile points of psychological flexibility. Results: The EE of those who were inflexible was higher than that of those whose flexibility was high moderate (p = 0.013) and who were flexible (p = 0.001). The UE of those who were inflexible was higher than the UE in the other groups with higher flexibility [low moderate (p = 0.034), high moderate (p een occupational burnout and EE and UE. Multivariate analysis of variances revealed that the combination of psychological flexibility and burnout had a stronger association with the variances of EE and UE than psychological flexibility alone. Conclusions: Persons who are psychologically inflexible have higher EE and UE. Future studies should investigate if increasing psychological flexibility helps decrease EE and UE.

Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions

Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.