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Maintaining healthy behaviors is challenging. Based upon previous reports that in North Carolina (NC), USA, overweight/obese clergy lost weight during a two-year religiously tailored health intervention, we described trajectories of diet, physical activity, and sleep. We investigated whether behavior changes were associated with weight and use of health-promoting theological messages. Improvements were observed in sleep, calorie-dense food intake, and physical activity, with the latter two associated with weight loss. While theological messages were well-retained, their relationship with behaviors depended on the specific message, behavior, and timing. Findings offer insights into weight loss mechanisms, including the role of theological messages in religiously tailored health interventions. [ABSTRACT FROM AUTHOR]

Background: Despite the high number of children living with neurodevelopmental disabilities in sub–Saharan Africa, access to early intervention is almost non-existent. It is therefore important to develop feasible, scalable early autism intervention that can be integrated into systems of care. While Naturalistic Developmental Behavioural Intervention (NDBI) has emerged as an evidence-based intervention approach, implementation gaps exist globally, and task-sharing approaches may address access gaps. In this South African proof-of-principle pilot study, we set out to answer two questions about a 12-session cascaded task-sharing NDBI—whether the approach could be delivered with fidelity, and whether we could identify signals of change in child and caregiver outcomes. Methods: We utilized a single-arm pre-post design. Fidelity (non-specialists, caregivers), caregiver outcomes (stress, sense of competence), and child outcomes (developmental, adaptive) were measured at baseline (T1) and follow-up (T2). Ten caregiver-child dyads and four non-specialists participated. Pre-to-post summary statistics were presented alongside individual trajectories. Non-parametric Wilcoxon signed rank test for paired samples was used to compare group medians between T1 and T2. Results: Caregiver implementation fidelity increased in 10/10 participants. Non-specialists demonstrated a significant increase in coaching fidelity (increases in 7/10 dyads). Significant gains were seen on two Griffiths-III subscales (Language/Communication—9/10 improved, Foundations of Learning—10/10 improved) and on the General Developmental Quotient (9/10 improved). Significant gains were also seen on two Vineland Adaptive Behaviour Scales (Third Edition) subscales (Communication—9/10 improved, Socialization—6/10 improved) and in the Adaptive Behaviour Standard Score (9/10 improved). Caregiver sense of competence improved in 7/10 caregivers and caregiver stress in 6/10 caregivers. Conclusions: This proof-of-principle pilot study of the first cascaded task-sharing NDBI in Sub-Saharan Africa provided fidelity and intervention outcome data which supported the potential of such approaches in low-resource contexts. Larger studies are needed to expand on the evidence-base and answer questions on intervention effectiveness and implementation outcomes. [ABSTRACT FROM AUTHOR]

Group-randomized trials are randomized studies that allocate intact groups of individuals to different comparison arms. A frequent practical limitation to adopting such research designs is that only a limited number of groups may be available, and therefore, simple randomization is unable to adequately balance multiple group-level covariates between arms. Therefore, covariate-based constrained randomization was proposed as an allocation technique to achieve balance. Constrained randomization involves generating a large number of possible allocation schemes, calculating a balance score that assesses covariate imbalance, limiting the randomization space to a prespecified percentage of candidate allocations, and randomly selecting one scheme to implement. When the outcome is binary, a number of statistical issues arise regarding the potential advantages of such designs in making inference. In particular, properties found for continuous outcomes may not directly apply, and additional variations on statistical tests are available. Motivated by two recent trials, we conduct a series of Monte Carlo simulations to evaluate the statistical properties of model-based and randomization-based tests under both simple and constrained randomization designs, with varying degrees of analysis-based covariate adjustment. Our results indicate that constrained randomization improves the power of the linearization F-test, the KC-corrected GEE t-test (Kauermann and Carroll, 2001, Journal of the American Statistical Association 96, 1387-1396), and two permutation tests when the prognostic group-level variables are controlled for in the analysis and the size of randomization space is reasonably small. We also demonstrate that constrained randomization reduces power loss from redundant analysis-based adjustment for non-prognostic covariates. Design considerations such as the choice of the balance metric and the size of randomization space are discussed. [ABSTRACT FROM AUTHOR]

Background: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron. Objective: We assessed the efficacy of the consumption of ironsupplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration <12 g/dL) Indian women of reproductive age. Design: The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively. Results: Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04). Conclusions: The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat anemia in India. This trial was registered at clinicaltrials.gov as NCT02032615. [ABSTRACT FROM AUTHOR]

Background: The negative effects of perinatal depression on the mother and child start early and persist throughout the lifecourse (Lancet 369(9556):145-57, 2007; Am J Psychiatry 159(1):43-7, 2002; Arch Dis Child 77(2):99-101, 1997; J Pak Med Assoc 60(4):329; J Psychosoma Res 49(3):207-16, 2000; Clin Child Fam Psychol Rev 14(1):1-27, 2011). Given that 10-35 % of children worldwide are exposed to perinatal depression in their first year of life (Int Rev Psychiatry 8(1):37-54, 1996), mitigating this intergenerational risk is a global public health priority (Perspect Public Health 129(5):221-7, 2009; Trop Med Int Health 13(4):579-83, 2008; Br Med Bull 101(1):57-79, 2012). However, it is not clear whether intervention with depressed women can have long-term benefits for the mother and/or her child. We describe a study of the effectiveness of a peer-delivered depression intervention delivered through 36 postnatal months, the Thinking Healthy Program Peer-delivered PLUS (THPP+) for women and their children in rural Pakistan.Methods/design: The THPP+ study aims are: (1) to evaluate the effects of an extended 36-month perinatal depression intervention on maternal and index child outcomes using a cluster randomized controlled trial (c-RCT) and (2) to determine whether outcomes among index children of perinatally depressed women in the intervention arm converge with those of index children born to perinatally nondepressed women. The trial is designed to recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 score ≥10) from 40 village clusters, of which 20 receive the THPP+ intervention. An additional reference group consists of 560 perinatally nondepressed women from the same 40 clusters as the THPP+ trial. The women in the nondepressed group are not targeted to receive the THPP+ intervention; but, by recruiting pregnant women from both intervention and control clusters, we are able to evaluate any carryover effects of the THPP+ intervention on the women and their children. Perinatally depressed women in the THPP+ intervention arm receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child development indicators. Analyses are intention-to-treat and account for the clustered design.Discussion: This trial, together with the reference group, has the potential to further our understanding of the early developmental lifecourse of children of both perinatally depressed and perinatally nondepressed women in rural Pakistan and to determine whether intervening with women's depression in the perinatal period can mitigate the negative effects of maternal depression on 36-month child development.Trial Registration: THPP-P ClinicalTrials.gov Identifier: NCT02111915 (registered on 9 April 2014). THPP+ ClinicalTrials.gov Identifier: NCT02658994 (registered on 21 January 2016).Sponsor: Human Development Research Foundation (HDRF). [ABSTRACT FROM AUTHOR]

AIDS-related mortality among HIV-positive adolescents has risen by 50% despite the scale up of antiretroviral therapy (ART). ART maladherence likely plays a role in the increase of AIDS-related deaths among adolescents and has shown to be associated with psychosocial and mental health difficulties. Addressing the specific mental health needs of HIV-positive adolescents is critical to ending the HIV epidemic. This cross-sectional study prospectively enrolled HIV-positive adolescents (12–24 years) in Moshi, Tanzania. A structured questionnaire was administered that included questions about home, school, adherence, and measures of stigma (Berger Stigma Scale) and mental health. Mental health measures included depression (Patient Health Questionnaire-9), emotional/behavioral difficulties (Strengths and Difficulties Questionnaire), and traumatic experiences/post-traumatic stress symptoms (The University of California Los Angeles-post-traumatic stress disorder-Reaction Index). Mental health difficulties were prevalent among HIV-positive adolescents and were associated with incomplete adherence and stigma. Resources are needed to reduce HIV stigma and address mental health among HIV-positive adolescents in low-resource settings. This will improve not only mental health, but may also improve ART adherence and virologic suppression, improving overall health of the individual and reducing the risk of HIV transmission to others. [ABSTRACT FROM AUTHOR]

Background: Ductal carcinoma in situ (DCIS) is a noninvasive breast lesion with uncertain risk for invasive progression. Usual care (UC) for DCIS consists of treatment upon diagnosis, thus potentially overtreating patients with low propensity for progression. One strategy to reduce overtreatment is active surveillance (AS), whereby DCIS is treated only upon detection of invasive disease. Our goal was to perform a quantitative evaluation of outcomes following an AS strategy for DCIS.Methods: Age-stratified, 10-year disease-specific cumulative mortality (DSCM) for AS was calculated using a computational risk projection model based upon published estimates for natural history parameters, and Surveillance, Epidemiology, and End Results data for outcomes. AS projections were compared with the DSCM for patients who received UC. To quantify the propagation of parameter uncertainty, a 95% projection range (PR) was computed, and sensitivity analyses were performed.Results: Under the assumption that AS cannot outperform UC, the projected median differences in 10-year DSCM between AS and UC when diagnosed at ages 40, 55, and 70 years were 2.6% (PR = 1.4%-5.1%), 1.5% (PR = 0.5%-3.5%), and 0.6% (PR = 0.0%-2.4), respectively. Corresponding median numbers of patients needed to treat to avert one breast cancer death were 38.3 (PR = 19.7-69.9), 67.3 (PR = 28.7-211.4), and 157.2 (PR = 41.1-3872.8), respectively. Sensitivity analyses showed that the parameter with greatest impact on DSCM was the probability of understaging invasive cancer at diagnosis.Conclusion: AS could be a viable management strategy for carefully selected DCIS patients, particularly among older age groups and those with substantial competing mortality risks. The effectiveness of AS could be markedly improved by reducing the rate of understaging. [ABSTRACT FROM AUTHOR]

Background: In order to begin to address the burden of non-communicable diseases (NCDs) in sub-Saharan Africa, high quality community-based epidemiological studies from the region are urgently needed. Cluster-designed sampling methods may be most efficient, but designing such studies requires assumptions about the clustering of the outcomes of interest. Currently, few studies from Sub-Saharan Africa have been published that describe the clustering of NCDs. Therefore, we report the neighborhood clustering of several NCDs from a community-based study in Northern Tanzania.Methods: We conducted a cluster-designed cross-sectional household survey between January and June 2014. We used a three-stage cluster probability sampling method to select thirty-seven sampling areas from twenty-nine neighborhood clusters, stratified by urban and rural. Households were then randomly selected from each of the sampling areas, and eligible participants were tested for chronic kidney disease (CKD), glucose impairment including diabetes, hypertension, and obesity as part of the CKD-AFRiKA study. We used linear mixed models to explore clustering across each of the samplings units, and we estimated absolute-agreement intra-cluster correlation (ICC) coefficients (ρ) for the neighborhood clusters.Results: We enrolled 481 participants from 346 urban and rural households. Neighborhood cluster sizes ranged from 6 to 49 participants (median: 13.0; 25th-75th percentiles: 9-21). Clustering varied across neighborhoods and differed by urban or rural setting. Among NCDs, hypertension (ρ = 0.075) exhibited the strongest clustering within neighborhoods followed by CKD (ρ = 0.440), obesity (ρ = 0.040), and glucose impairment (ρ = 0.039).Conclusion: The neighborhood clustering was substantial enough to contribute to a design effect for NCD outcomes including hypertension, CKD, obesity, and glucose impairment, and it may also highlight NCD risk factors that vary by setting. These results may help inform the design of future community-based studies or randomized controlled trials examining NCDs in the region particularly those that use cluster-sampling methods. [ABSTRACT FROM AUTHOR]

In randomized trials of provider-focused clinical interventions, treatment allocation often cannot be blinded to participants, study staff, or providers. The choice of unit of randomization (patient, provider, or clinic) entails tradeoffs in cost, power, and bias. Provider- or clinic-level randomization can minimize contamination, but it incurs the equally problematic potential for referral bias; that is, because arm assignment of future participants generally cannot be concealed, differences between arms may arise in the types of patients enrolled. Pseudo-cluster randomization is a novel study design that balances these competing validity threats. Providers are randomly assigned to an imbalanced proportion of intervention-arm participants (e.g., 80% or 20%). Providers can be masked to the imbalance, avoiding referral bias. Contamination is reduced because only a minority of control-arm participants are treated by majority-intervention providers. Pseudo-cluster randomization was implemented in a randomized trial of a decision support intervention to manage depression among patients receiving human immunodeficiency virus care in the southern United States in 2010-2014. The design appears successful in avoiding referral bias (participants were comparable between arms on important characteristics) and contamination (key depression treatment indicators were comparable between usual care participants managed by majority-intervention and majority-usual care providers and were markedly different compared with intervention participants). [ABSTRACT FROM AUTHOR]

Objective: To describe the preoperative surgical case mix among patients undergoing cataract extraction and explore associations between case mix, country level of development (as measured by the Human Development Index, HDI) and cataract surgery rates (CSRs). Methods: Ophthalmologists in 50 countries were invited to join the newly-established International Eye Research Network and asked to complete a web-based questionnaire about their eye hospitals. Those who complied received a data collection form for recording demographic and clinical data on 100 consecutive patients about to undergo cataract surgery. Countries were ranked into five HDI categories and multivariable regression was used to explore associations. Findings: Ophthalmologists at 112 eye hospitals (54% of them nongovernmental) in 50 countries provided data on 11 048 cataract procedures over 9 months in 2008. Patients whose visual acuity (VA) before surgery was < 6/60 in the better eye comprised 47% of the total case mix in poorly developed countries and 1% in developed countries (P < 0.001). Overall, 72% of the eyes undergoing surgery had a VA < 6/60. Very low VA before cataract surgery was strongly associated with poor development at the country level and inversely associated with national CSR. Conclusion: The proportion of patients with very poor preoperative VA is a simple indicator that can be easily measured periodically to monitor progress in ophthalmological services. Additionally, the internet can be an effective tool for developing and supporting an ophthalmological research network capable of providing a global snapshot of service activity, particularly in developing countries. [ABSTRACT FROM AUTHOR]