Correction: Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/50330.].

Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

BACKGROUND: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points). CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.

Healthy eating and all-cause mortality among Chinese aged 80 years or older.

BACKGROUND: There is little evidence of the influence of dietary patterns on mortality risk among adults 80 years or older ("oldest-old"). We evaluated the association between the Simplified Healthy Eating index (SHE-index) and mortality among Chinese oldest-old. METHODS: Population-based cohort study from the Chinese Longitudinal Healthy Longevity Survey (CLHLS 1998-2014, n = 35 927), conducted in 22 Chinese provinces, were pooled for analysis. The first seven waves of the CLHLS (1998, 2000, 2002, 2005, 2008-09, 2011-12, and 2013-2014) were utilized, with follow-up to the last wave (2018) (range 0-21 years). The SHE-index was collected in each wave, and was constructed from intake frequency of nine dietary variables, with a higher score indicating better diet quality. Cox proportional hazards model with dietary patterns as a time-varying exposure was employed to analyze the relationship between SHE-index and mortality. RESULTS: At baseline, the median age of all participants was 92 years (25th percentile, 85 years; 75th percentile, 100 years). In multivariable models, the hazard ratios (95% confidence intervals) for SHE-index quartile 2, quartile 3 and quartile 4 versus quartile1 were 0.91 (0.88, 0.93), 0.89 (0.86, 0.92) and 0.82 (0.78, 0.85), respectively. Results were generally consistent for men and women and in a large number of sensitivity analyses. CONCLUSIONS: Healthier eating patterns were associated with a significant reduction in the risk of all-cause mortality among Chinese oldest-old, lending support to the importance of life-long adherence to healthy diet into advanced old age.

Sauti ya Vijana (SYV; The Voice of Youth): Longitudinal Outcomes of an Individually Randomized Group Treatment Pilot Trial for Young People Living with HIV in Tanzania.

Sauti ya Vijana is a mental health and life skills intervention delivered by young adult group leaders for the improvement of HIV outcomes in young people living with HIV in Tanzania. This pilot randomized controlled trial estimated exploratory intervention effectiveness compared to standard of care. YPLWH (N = 105) were randomized to receive intervention or SOC. The mean age of participants was 18.1 years and 53% were female. Mean scores on mental health measures (Patient Health Questionnaire [PHQ-9], Strengths and Difficulties Questionnaire [SDQ], UCLA Trauma) were asymptomatic to mild in both study arms through 30-month follow-up with a non-significant fluctuation of 1-2 points. The mean self-reported adherence was higher in the intervention arm across all time points (but the confidence interval contained the null at all time points except 6 months). Risk ratio of virologic suppression (HIV RNA < 400 copies/mL) in the intervention arm compared to SOC was 1.15 [95% CI = 0.95, 1.39]) at 6-months, 1.17 [95% CI: 0.92, 1.48] at 12-months, and 0.99 [95% CI 0.76, 1.31] at 18-months. Though these findings were not powered for statistical significance, the trends in HIV outcomes suggest that SYV holds promise for improving antiretroviral therapy (ART) adherence and virologic suppression in YPLWH.

Stressful life events, intimate partner violence, and perceived stress in the postpartum period: longitudinal findings in rural Pakistan.

PURPOSE: While the association between intimate partner violence (IPV) and stress is well documented, the directionality of this relationship is unclear. We use an adjusted longitudinal study design to better understand if stressful life events in the home precipitate or exacerbate intimate partner violence (IPV) and if experiences of IPV, in turn, increase levels of perceived stress. METHODS: Longitudinal data were collected among married women in rural Pakistan at 12 and 24 months postpartum (N = 815). Adjusted Poisson and linear regression models were used to examine stressful life events, past year IPV and severity (number and frequency of violent acts), and perceived stress (Cohen Perceived Stress Scale). RESULTS: At 12 months postpartum, the prevalence of past year physical, psychological, and sexual IPV was 8.5%, 25.7%, and 25.1%, respectively, with 42.6% experiencing any IPV. After adjustment, stressful life events were associated with a subsequent increased likelihood of all IPV types and increased severity of all but physical IPV. Any past year IPV (versus none) and greater IPV severity were associated with 3.43 (95% CI 2.33-4.52) and 2.57 (95% CI 1.87-3.27) point subsequent increases in perceived stress. Physical, psychological, and sexual IPV and their respective severities were all independently associated with increased perceived stress. CONCLUSIONS: Among postpartum women in Pakistan, stressful life events increase the likelihood of IPV and, in turn, experiences of IPV increase stress levels. Support to families undergoing stressful circumstances may be critical to reducing women's IPV exposure and resulting elevated stress.

power swgee: GEE-based power calculations in stepped wedge cluster randomized trials.

Stepped wedge cluster randomized trials are increasingly being used to evaluate interventions in medical, public health, educational, and social science contexts. With the longitudinal and crossover nature of a SW-CRT, complex analysis techniques are often needed which makes appropriately powering SW-CRTs challenging. In this paper, we introduce a newly-developed SW-CRT power calculator, embedded within the power command in Stata. The power calculator assumes a marginal model (i.e., generalized estimating equations [GEE]) for the primary analysis of SW-CRTs, for which other currently available SW-CRT power calculators may not be suitable. The program accommodates complete cross-sectional and closed-cohort designs, and includes multilevel correlation structures appropriate for such designs. We discuss the methods and formulae underlying our SW-CRT calculator, and provide illustrative examples of the use of power swgee. We provide suggestions about the choice of parameters in power swgee, and conclude by discussing areas of future research which may improve the program.

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial.

BACKGROUND: Managing noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China. METHODS AND FINDINGS: Based on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting. CONCLUSIONS: In this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China. TRIAL REGISTRATION: ClinicalTrials.gov NCT03185858.

Common mental disorders and intimate partner violence against pregnant women living with HIV in Cameroon: a cross-sectional analysis.

BACKGROUND: Women living with HIV are at increased risk of poor mental health and intimate partner violence (IPV). Mental health disorders have been consistently associated with suboptimal HIV-related outcomes. Little is known about the prevalence or correlates of mental health disorders among pregnant women living with HIV in sub-Saharan Africa. METHODS: This study assessed the prevalence of probable common mental disorders (CMD), i.e., depressive or anxiety disorders, and the relationship between probable CMD and recent IPV among pregnant women living with HIV in Cameroon. The sample included 230 pregnant women living with HIV aged > 18 enrolled in care at 10 HIV clinics in Cameroon. Probable CMD was assessed with the WHO Self Reporting Questionnaire (SRQ-20). Multivariable logistic regression was conducted to assess the relationship between IPV and probable CMD. RESULTS: Almost half (42%) of participants had probable CMD using a 7/8 cut-off of the SRQ-20. Emotional, physical, and sexual IPV were reported by 44, 37, and 31% of respondents, respectively. In multivariable regression analyses, all forms of IPV assessed were significantly associated with greater odds of probable CMD. CONCLUSIONS: Pregnant women living with HIV in Cameroon had a high prevalence of probable CMD and IPV. Screening and services to address IPV and mental health are urgently needed for this population. Integrated interventions to both prevent and screen and address IPV and probable CMD should be developed, implemented, and evaluated.

Prevalence and correlates of maternal early stimulation behaviors during pregnancy in northern Ghana: a cross-sectional survey.

BACKGROUND: Per UNICEF's Nurturing Care Framework, early childhood development (ECD) begins during pregnancy and many lower-resource settings need data to inform their programs for optimal child development. The maternal-fetal relationship can be partly examined via a series of bonding activities called early stimulation behaviors (ESB). This study describes early stimulation behaviors and the associated correlates among pregnant women in Ghana. METHODS: This cross-sectional study used data from a cluster-randomized trial in two districts of Northern Ghana. A total of 374 pregnant women were enrolled at baseline and administered a pre-intervention survey. Communication-related early stimulation behaviors was the primary outcome which was evaluated using three maternal-fetal bonding activities; did the woman self-report touching and/or talking, singing, and/or talking about family to her belly. A generalized estimating equation modified Poisson model was used for the bivariate and multivariable analysis. RESULTS: About half of the participants reported performing communication-related ESB during pregnancy frequently or sometimes. Bivariate analysis revealed that negative life experiences including higher rates of emotional, physical and sexual intimate partner violence (IPV) and having moderate to severe depressive symptoms were associated with women performing early stimulation behaviors more often. In the multivariable model, physical intimate partner violence remained significantly associated with early stimulation behaviors. CONCLUSION: Research on early stimulation behaviors is still in a nascent phase. It is unclear why our results revealed an association between intimate partner violence and early stimulation behaviors; this could reflect a coping mechanism for the expectant mother. Further research is needed to better understand this association and explore potential long-term impacts of early stimulation behaviors during pregnancy on child development. TRIAL REGISTRATION: Clinical Trials # NCT03665246 , August 29, 2018.

Feasibility and acceptability of a peer youth led curriculum to improve HIV knowledge in Northern Tanzania: resilience and intervention experience from the perspective of peer leaders.

BACKGROUND: Youth Living with HIV (YLWH) have reduced adherence to antiretroviral therapy (ART) and worse virologic outcomes compared to children and adults. HIV peer youth led (PYL) interventions contribute to improved retention in care and psychosocial wellbeing. The study objective was to assess the feasibility and acceptability of a PYL HIV curriculum and describe change in participants' knowledge and impact of leadership on peer leaders' lives. METHODS: An HIV curriculum was taught during monthly Saturday adolescent HIV clinics at two clinical sites in Moshi, Tanzania (2018-2019). Youth attending clinics were ages 12 to 24 years and received the HIV curriculum during routine clinical care. Peer leaders previously participated in a mental health and life skills intervention called Sauti ya Vijana (The Voice of Youth; SYV) and were recommended for leadership by SYV facilitators and clinic staff. Peer leaders were trained and supervised weekly in curriculum delivery using a "train the trainer" model. Data were collected and analyzed using mixed methods. Fidelity checklists were used to measure adherence to the curriculum. Youth participants answered written pre- and post-knowledge questions and evaluated PYL teaching. Semi-structured interviews and the Connor Davidson Resilience scale were conducted with peer leaders before and after assuming the leadership role. RESULTS: Peer leaders (N = 4 male; 3 female) demonstrated high fidelity (96%) to activities in each lesson and participant feedback was positive for curriculum delivery. Participants' knowledge improved in nine of ten sessions. All but one leader-who moved away before the study ended-demonstrated stable or improved resilience with a mean difference of 3.8 (SD = 7.0) from before the intervention to after assuming the leadership role. Peer leaders reported improved leadership confidence and resilience, and their perception was that the curriculum helped normalize the HIV experience for YLWH attending clinic. Nevertheless, anticipated stigma, difficulty disclosing HIV status, and teaching ability remained barriers. CONCLUSIONS: This study demonstrated that a PYL curriculum to improve HIV knowledge integrated into routine adolescent HIV clinic in Tanzania was feasible, acceptable, and improved knowledge while also benefiting peer leaders, thus providing evidence to continue to support efforts to scale and sustain PYL interventions for YLWH.

The impact of a maternal mental health intervention on intimate partner violence in Northern Ghana and the mediating roles of social support and couple communication: secondary analysis of a cluster randomized controlled trial.

BACKGROUNDS: Diverse intervention efforts are implemented to address intimate partner violence (IPV) against women. Via a syndemics theory lens and emerging empirical evidence, mental health interventions demonstrate promise to partially ameliorate IPV. However, the mechanisms of change underlying many IPV interventions are not well understood. These gaps impede our efforts to strengthen or integrate effective components into the current mental health resources, especially in low- and middle-income countries (LMICs). This study aims to examine the impact of a maternal mental health intervention called Integrated Mothers and Babies Course & Early Childhood Development (iMBC/ECD) on IPV and whether social support and/or couple communication mediates the intervention effects among women in rural, Northern Ghana. METHODS: The current study is a secondary data analysis of a cluster randomized controlled trial. IPV was measured at baseline and 8 months post-intervention (~ 19 months post-baseline). At baseline, 84.8% of the women enrolled in the study (n = 374) reported some type of IPV in the past 12 months. Logistic regression models and multiple mediation analyses were used to address the study aims. RESULTS: iMBC/ECD did not reduce IPV in the intervention group compared to the control group. Social support and couple communication did not mediate the intervention effects on IPV as indicated by the indirect effects of the multiple mediation models. However, increase in social support reduced women's odds of experiencing emotional violence by 7%, odds ratio (OR) = 0.93, p = 0.007; b = - 0.07, 95% confidence interval (CI) = (- 0.13, - 0.02), and improvement in couple communication demonstrated promise in reducing women's odds of experiencing controlling behaviors by 7%, OR = 0.93, p = 0.07; b = - 0.07, CI = (- 0.14, 0.005), though the improvements were not due to the intervention. CONCLUSION: This maternal mental health intervention did not reduce IPV; however, the findings extend our knowledge about the impact of such interventions on IPV and the potential mechanisms of change via social support and couple communication. Future research evaluating the impact of mental health interventions on IPV and mechanisms of change is essential for the development of effective interventions. Future programs addressing IPV in LMICs should consider risk factors beyond relationship level (e.g. poverty and gender inequity). TRIAL REGISTRATION: ClinicalTrials.gov # NCT03665246 , Registered on August 20th, 2018.

Adverse childhood experiences and depression among women in rural Pakistan.

BACKGROUND: Adverse Childhood Experiences (ACEs) are a common pathway to adult depression. This pathway is particularly important during the perinatal period when women are at an elevated risk for depression. However, this relationship has not been explored in South Asia. This study estimates the association between ACEs and women's (N = 889) depression at 36 months postpartum in rural Pakistan. METHOD: Data come from the Bachpan Cohort study. To capture ACEs, an adapted version of the ACE-International Questionnaire was used. Women's depression was measured using both major depressive episodes (MDE) and depressive symptom severity. To assess the relationship between ACEs and depression, log-Poisson models were used for MDE and linear regression models for symptom severity. RESULTS: The majority (58%) of women experienced at least one ACE domain, most commonly home violence (38.3%), followed by neglect (20.1%). Women experiencing four or more ACEs had the most pronounced elevation of symptom severity (ß = 3.90; 95% CL = 2.13, 5.67) and MDE (PR = 2.43; 95% CL = 1.37, 4.32). Symptom severity (ß = 2.88; 95% CL = 1.46, 4.31), and MDE (PR = 2.01; 95% CL = 1.27, 3.18) were greater for those experiencing community violence or family distress (ß = 2.04; 95%; CL = 0.83, 3.25) (PR = 1.77; 95% CL = 1.12, 2.79). CONCLUSIONS: Findings suggest that ACEs are substantively distinct and have unique relationships to depression. They signal a need to address women's ACEs as part of perinatal mental health interventions and highlight women's lifelong experiences as important factors to understanding current mental health. TRIAL REGISTRATION: NCT02111915 . Registered 11 April 2014. NCT02658994 . Registered 22 January 2016. Both trials were prospectively registered.

The Effects of Antenatal Depression and Women's Perception of Having Poor Health on Maternal Health Service Utilization in Northern Ghana.

OBJECTIVES: To examine the effects of antenatal depression and women's perceived health during the antenatal period on maternal health service utilization in rural northern Ghana; including how the effect of antenatal depression on service use might be modified by women's perceived health. METHODS: Probable antenatal depression was assessed using the Patient Health Questionnaire (PHQ-9). Linear regression was used for the outcome of number of antenatal care (ANC) visits, and logistic regression was used for the outcomes of facility delivery, postnatal care (PNC) within 7 days and completion of continuum of care. Continuum of care was defined as having had four or more ANC visits, delivered at a health facility and had PNC visit within 7 days. RESULTS: Antenatal depression had very small or no association with maternal health service utilization. Women with self-perceived fair or poor health were significantly less likely to use PNC within 7 days and less likely to complete the continuum of care. As for effect modification, we found that for women with probable moderate or severe antenatal depression (a score of 10 or greater), those with perceived fair or poor health used fewer ANC visits and were less likely to use PNC within 7 days than those with perceived excellent, very good or good health. CONCLUSIONS: Women experiencing moderate or severe antenatal depression and/or who self-perceive as having poor health should be identified and targeted for additional support to access and utilize maternal health services.

A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

BACKGROUND: Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH. METHODS: This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling. RESULTS: Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36). CONCLUSIONS: YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.

Maternal depression in rural Pakistan: the protective associations with cultural postpartum practices.

BACKGROUND: Traditional postpartum practices are intended to provide care to mothers, but there is mixed evidence concerning their impact on postpartum depression (PPD). It remains unknown if there is a unique impact of postpartum practices on PPD separately from other types of social support, or if practices differentially affect those with existing prenatal depression. In Pakistan, chilla (چله) is a traditional postpartum practice in which women receive relief from household work, additional familial support, and supplemental food for up to 40 days postpartum. This study aims to understand if chilla protects against PPD independent of other support and whether this relationship varies by prenatal depression status. METHODS: Data come from the Bachpan cohort study in rural Pakistan. Chilla participation and social support (Multidimensional Scale of Perceived Social Support) were assessed at 3 months postpartum. Women were assessed for major depressive episodes (MDE) with the Structured Clinical Interview, DSM-IV and for depression symptom severity with the Patient Health Questionnaire (PHQ-9) in their third trimester and at 6 months postpartum. Adjusted linear mixed models were used to assess the relationship between chilla participation and PPD. RESULTS: Eighty-nine percent of women (N = 786) participated in chilla and almost 70% of those that participated took part in all of chilla's aspects. In adjusted models, chilla participation was inversely related to MDE (OR = 0.56;95%CI = 0.31,1.03) and symptom severity (Mean Difference (MD) = - 1.54;95%CI: - 2.94,-0.14). Chilla participation was associated with lower odds of MDE (OR = 0.44;95%CI = 0.20,0.97) among those not prenatally depressed and with lower symptom severity among those prenatally depressed (MD = -2.05;95%CI:-3.81,-0.49). CONCLUSIONS: Chilla is inversely associated with both MDE and symptom severity at 6 months postpartum above and beyond social support. Specifically, chilla is inversely associated with MDE among those not prenatally depressed and with lower symptom severity among those prenatally depressed. This relationship signals an opportunity for interventions aimed at preventing and treating PPD in this region to draw upon chilla and similar traditional postpartum practices in creating community-based, low-cost, sustainable interventions for maternal mental health. TRIAL REGISTRATION: NCT02111915. Registered 18 September 2015. NCT02658994. Registered 22 January 2016. Both trials were prospectively registered.

xtgeebcv: A command for bias-corrected sandwich variance estimation for GEE analyses of cluster randomized trials.

Cluster randomized trials, where clusters (for example, schools or clinics) are randomized to comparison arms but measurements are taken on individuals, are commonly used to evaluate interventions in public health, education, and the social sciences. Analysis is often conducted on individual-level outcomes, and such analysis methods must consider that outcomes for members of the same cluster tend to be more similar than outcomes for members of other clusters. A popular individual-level analysis technique is generalized estimating equations (GEE). However, it is common to randomize a small number of clusters (for example, 30 or fewer), and in this case, the GEE standard errors obtained from the sandwich variance estimator will be biased, leading to inflated type I errors. Some bias-corrected standard errors have been proposed and studied to account for this finite-sample bias, but none has yet been implemented in Stata. In this article, we describe several popular bias corrections to the robust sandwich variance. We then introduce our newly created command, xtgeebcv, which will allow Stata users to easily apply finite-sample corrections to standard errors obtained from GEE models. We then provide examples to demonstrate the use of xtgeebcv. Finally, we discuss suggestions about which finite-sample corrections to use in which situations and consider areas of future research that may improve xtgeebcv.

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

BACKGROUND: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION: NCT03003403 . Registered December 28, 2016.

Building resilience: a mental health intervention for Tanzanian youth living with HIV.

Despite a growing population of youth living with HIV, few interventions have been developed to address their unique mental health needs and to promote resilience. Based on our prior needs assessment, a mental health intervention, Sauti ya Vijana ( The Voice of Youth), was developed to address identified mental health needs and promote resilience. The intervention emphasized resilience strategies for identifying and coping with stressful events, supporting strong familial and social relationships, and planning for a safe and healthy living environment through stigma reduction, planning for disclosure, and instilling hope for the future. Ten group sessions (two of which were joint youth/caregiver sessions) and two individual sessions were developed around these three resilience domains. Youth living with HIV (average age 17.4 years), who were receiving antiretroviral therapy and attending HIV adolescent clinic in Tanzania were randomized to intervention or treatment as usual. Trained group leaders led the intervention sessions. Near perfect program fidelity by the group leaders and unanimous acceptance of the intervention by the youth was documented. SYV successfully promoted youth resilience as measured by youth-reported utilization of new coping skills, improved peer and caregiver relationships, reduced stigma, and improved confidence to live positively according to their personal values.

cvcrand and cptest: Commands for efficient design and analysis of cluster randomized trials using constrained randomization and permutation tests.

Cluster randomized trials (CRTs), where clusters (for example, schools or clinics) are randomized to comparison arms but measurements are taken on individuals, are commonly used to evaluate interventions in public health, education, and the social sciences. Because CRTs typically involve a small number of clusters (for example, fewer than 20), simple randomization frequently leads to baseline imbalance of cluster characteristics across study arms, threatening the internal validity of the trial. In CRTs with a small number of clusters, classic approaches to balancing baseline characteristics-such as matching and stratification-have several drawbacks, especially when the number of baseline characteristics the researcher desires to balance is large (Ivers et al., 2012, Trials 13: 120). An alternative design approach is covariate-constrained randomization, whereby a randomization scheme is randomly selected from a subset of all possible randomization schemes based on the value of a balancing criterion (Raab and Butcher, 2001, Statistics in Medicine 20: 351-365). Subsequently, a clustered permutation test can be used in the analysis, which provides increased power under constrained randomization compared with simple randomization (Li et al., 2016, Statistics in Medicine 35: 1565-1579). In this article, we describe covariate-constrained randomization and the permutation test for the design and analysis of CRTs and provide an example to demonstrate the use of our new commands cvcrand and cptest to implement constrained randomization and the permutation test.

Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.