Community-based Randomized Control Trial Research Articles

EFFECTIVENESS OF THE LEBED METHOD THERAPEUTIC INTERVENTION ON PHYSICAL STABILITY AMONG ELDERLY INDIVIDUALS IN KAKAMEGA COUNTY

Background. In Kenya, falls among individuals over 60 years of age are a major concern. Despite physical activity being known to reduce fall risks, existing studies face challenges like high drop-out rates and limited exercise types. The Lebed Method, a dance program originally developed for breast cancer survivors by Sherry Lebed Davis, has shown potential to improve physical and emotional well-being. This study aimed to explore its effectiveness in improving physical stability among the elderly in Kakamega County. Methods. The study involved a community-based randomized control trial with 30 participants aged 60 and older, selected based on low social support scores. They were divided into intervention and control groups, meeting specific inclusion criteria. Baseline functional stability (mobility and balance) was assessed by Timed Up and Go (TUG), Berg Balance Scale (BBS) scores, gait speed time, and de Morton Mobility Index (DEMMI) score. To ensure the reliability of the study, biases such as selection, performance, detection, attrition, and reporting biases were addressed. Changes in physical stability between the groups were analyzed using the Analysis of Covariance, accounting for baseline differences, while within-group changes were evaluated using the dependent sample t-test. The threshold for statistical significance was set at p < 0.05. Results. The findings showed that the intervention group improved significantly in physical stability compared to the control group. Specifically, notable enhancements were observed on TUG times (p < .001, ηp2 = 0.53, d = 3.38), BBS scores (p < .001, ηp2 = 0.64, d = 1.97), gait speed (p < .001, ηp2 = 0.65, d = 1.99) and DEMMI score (p < .001, ηp2 = 0.38, d = 1.94). Conclusions. The intervention significantly improved mobility and balance among participants, demonstrating the effectiveness of the Lebed method for elderly individuals. Future research could explore specific components of dance-based therapy that contribute to functional mobility and balance improvements

The Interactions between Maternal Iron Supplementation and Iron Metabolism-Related Genetic Polymorphisms on Birth Outcomes: A Prospective Study in Chinese

BackgroundThe effect of iron supplementation during pregnancy on birth outcomes may vary with maternal genetic background and needs more investigation. ObjectivesThis prospective study aimed to evaluate the interactions between maternal iron supplementation and iron metabolism-related genetic polymorphisms on birth outcomes. MethodsThis was a substudy from a community-based randomized control trial conducted in Northwest China, which included 860 women from the 2 micronutrient supplementation groups (folic acid [FA] and FA + iron group). Maternal peripheral blood, sociodemographic and health-related information, and neonatal birth outcomes were collected. Six single nucleotide polymorphisms in iron metabolism-related genes were genotyped. The alleles associated with decreased iron/hemoglobin status were used as the effect alleles. The genetic risk score (GRS) that reflected the genetic risk of low iron/hemoglobin status was estimated using the unweighted and weighted methods. Generalized estimating equations with small-sample corrections were applied to evaluate the interactions between iron supplementation and SNPs/GRS on birth outcomes. ResultsThere were significant interactions between maternal iron supplementation and rs7385804 (P = 0.009), rs149411 (P = 0.035), rs4820268 (P = 0.031), the unweighted GRS (P = 0.018), and the weighted GRS (P = 0.009) on birth weight. Compared with FA supplementation only, FA + iron supplementation significantly increased birth weight among women with more effect alleles in rs7385804 (β: 88.8 g, 95% CI: 9.2, 168.3) and the GRSs (the highest unweighted GRS, β: 135.5 g, 95% CI: 7.7, 263.4; the highest weighted GRS, β: 145.9 g, 95% CI: 43.4, 248.5); it had a trend of decreasing birth weight and increasing low birth weight risk among women with fewer effect alleles. ConclusionsIn our population, maternal genetic background related to iron metabolism plays a significant role in determining the efficacy of iron supplementation. Routine iron supplementation could be more beneficial to fetal weight growth among mothers with higher genetic risk for low iron/hemoglobin status.

Module intervention to improve involvement and practices of fathers towards infant and young child feeding (IYCF) in Coastal South India - a randomized controlled trial

Background: Overall child health depends on nutrition and its related practices. At the family level, responsibility of child feeding lies with both parents.There is no uniform and systematic way to determine and assess the practices of fathers in infant and young child feeding (IYCF). Also, there is a paucity of evidence related to interventions for fathers in improving their practices and involvement in the feeding of their infant or young child (aged less than two years). Methods: This was a community-based randomized control trial, conducted among 120 fathers with infants and/or young children in Dakshina Kannada District of Karnataka. Fathers with poor level of involvement and practices towards IYCF, during the initial assessment, were included as the study participants. For the intervention, a module in the flipchart format was developed. Simple randomization technique was used to allot the participants into two groups - intervention and control. Participants in the intervention group received module intervention, in addition to the care which they received routinely, and the control group received only routine care. The participants in the intervention group were paid a monthly visit to implement the module, for six months. The post-intervention assessment was done at the end of 6 months. Results: A total of 117 participants provided post-intervention data.The mean age was 34.7 (+/- 5.48) years in the intervention group and 34.36 years (+/- 5.26) in the control group. The intervention group showed significantly higher improvement in knowledge, attitude, and practice components at 6 months (p<0.05), in both unadjusted and adjusted models. Conclusions: The extent of increase in practice and involvement in child feeding was clearly higher among the intervention group.The module developed was successful in improving the practices of fathers in feeding their infants and young children. Clinical Trials Registry India: CTRI/2017/06/008936 (29/06/2017).

Module intervention to improve involvement and practices of fathers towards infant and young child feeding (IYCF) in Coastal South India - a randomized controlled trial

Background: Overall child health depends on nutrition and its related practices. At the family level, responsibility of child feeding lies with both parents. There is no uniform and systematic way to determine and assess the practices of fathers in infant and young child feeding (IYCF). Also, there is a paucity of evidence related to interventions for fathers in improving their practices and involvement in the feeding of their infant or young child (aged less than two years). Methods: This was a community-based randomized control trial, conducted among 120 fathers with infants and/or young children in Dakshina Kannada District of Karnataka. Fathers with poor level of involvement and practices towards IYCF, during the initial assessment, were included as the study participants. For the intervention, a module in the flipchart format was developed. Simple randomization technique was used to allot the participants into two groups - intervention and control. Participants in the intervention group received module intervention, in addition to the care which they received routinely, and the control group received only routine care. The participants in the intervention group were paid a monthly visit to implement the module, for six months. The post-intervention assessment was done at the end of 6 months. Results: A total of 117 participants provided post-intervention data. The mean age was 34.7 (+/- 5.48) years in the intervention group and 34.36 years (+/- 5.26) in the control group. The intervention group showed significantly higher improvement in knowledge, attitude, and practice components at 6 months (p<0.05), in both unadjusted and adjusted models. Conclusions: The extent of increase in practice and involvement in child feeding was clearly higher among the intervention group. The module developed was successful in improving the practices of fathers in feeding their infants and young children. Clinical Trials Registry India: CTRI/2017/06/008936 (29/06/2017)

Module intervention to improve involvement and practices of fathers towards infant and young child feeding (IYCF) in Coastal South India - a randomized controlled trial.

Background: Overall child health depends on nutrition and its related practices. At the family level, responsibility of child feeding lies with both parents.There is no uniform and systematic way to determine and assess the practices of fathers in infant and young child feeding (IYCF). Also, there is a paucity of evidence related to interventions for fathers in improving their practices and involvement in the feeding of their infant or young child (aged less than two years). Methods: This was a community-based randomized control trial, conducted among 120 fathers with infants and/or young children in Dakshina Kannada District of Karnataka. Fathers with poor level of involvement and practices towards IYCF, during the initial assessment, were included as the study participants. For the intervention, a module in the flipchart format was developed. Simple randomization technique was used to allot the participants into two groups - intervention and control. Participants in the intervention group received module intervention, in addition to the care which they received routinely, and the control group received only routine care. The participants in the intervention group were paid a monthly visit to implement the module, for six months. The post-intervention assessment was done at the end of 6 months. Results: A total of 117 participants provided post-intervention data.The mean age was 34.7 (+/- 5.48) years in the intervention group and 34.36 years (+/- 5.26) in the control group. The intervention group had a significant improvement in knowledge, attitude, and practice components at 6 months. We noted higher change scores for the intervention group (p<0.05). Conclusions: The extent of increase in practice and involvement in child feeding was clearly higher among the intervention group.The module developed was successful in improving the practices of fathers in feeding their infants and young children. Clinical Trials Registry India: CTRI/2017/06/008936 (29/06/2017).

Effects of a maternal psychosocial intervention on hair derived biomarkers of HPA axis function in mothers and children in rural Pakistan

ObjectiveDisruptions in the hypothalamic-pituitary-adrenal (HPA) axis are thought to be key neuroendocrine mechanisms involved in psychopathology and may have intergenerational impacts. Hair-derived HPA hormones offer a measure of long-term HPA axis activity that may be useful in assessing maternal and infant health. Building on a community-based randomized control trial of a perinatal depression intervention in Pakistan, we examine intervention effects on HPA axis activity in a subsample of mothers and infants. MethodsHPA axis activity was assessed using hair-derived cortisol, cortisone, and dehydroepiandosterone (DHEA). Hair samples were collected from mother-child dyads at one year postpartum from prenatally depressed women randomized to a cognitive-behavioral intervention (n ​= ​35 dyads) or to enhanced usual care (n ​= ​37 dyads), and from a comparison sample of women who screened negative for depression in pregnancy (n ​= ​35 dyads). ResultsThe intervention group had 38 percent (p=0.01) lower maternal cortisol levels and 45 percent (p ​< ​0.01) lower maternal cortisone compared to the EUC group. Maternal DHEA levels were higher among women in the intervention group compared to the EUC group by 29 percent (p ​= ​0.02). Intergenerational intervention effects show higher DHEA levels in infants by 43% (p ​= ​0.03). Infant cortisol and cortisone did not differ across groups. ConclusionsResults suggest that the perinatal depression intervention has effects on HPA axis activity in both mothers and children, providing evidence that treating maternal depression may impact physiological stress system functioning intergenerationally. In addition, utilizing hair-derived biomarkers of HPA-axis activity is a potentially useful clinical indicator of intervention impacts on the neuroendocrine system.

Digital cognitive behaviour therapy for insomnia (dCBT-I): Chronotype moderation on intervention outcomes.

Using data from 1721 participants in a community-based randomized control trial of digital cognitive behavioural therapy for insomnia compared with patient education, we employed linear mixed modelling analyses to examine whether chronotype moderated the benefits of digital cognitive behavioural therapy for insomnia on self-reported levels of insomnia severity, fatigue and psychological distress. Baseline self-ratings on the reduced version of the Horne-Östberg Morningness-Eveningness Questionnaire were used to categorize the sample into three chronotypes: morning type (n=345; 20%); intermediate type (n=843; 49%); and evening type (n=524; 30%). Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale were assessed pre- and post-intervention (9 weeks). For individuals with self-reported morning or intermediate chronotypes, digital cognitive behavioural therapy for insomnia was superior to patient education on all ratings (Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale) at follow-up (p-values≤0.05). For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p=0.139). There were significant differences in the treatment effects between the three chronotypes on the Insomnia Severity Index (p=0.023) estimated difference between evening and morning type of -1.70, 95% confidence interval: -2.96 to -0.45, p=0.008, and estimated difference between evening and intermediate type -1.53, 95% confidence interval: -3.04 to -0.03, p=0.046. There were no significant differences in the treatment effects between the three chronotypes on the Chalder Fatigue Questionnaire (p=0.488) or the Hospital Anxiety and Depression Scale (p=0.536). We conclude that self-reported chronotype moderates the effects of digital cognitive behavioural therapy for insomnia on insomnia severity, but not on psychological distress or fatigue.

Cold Water Immersion Directly and Mediated by Alleviated Pain to Promote Quality of Life in Indonesian with Gout Arthritis: A Community-based Randomized Controlled Trial.

Background: Gout arthritis is an autoinflammatory arthritis that generates chronic long-term pain. Pain impacts physical activities, joint mobility, stress, anxiety, depression, and quality of life. Cold-water immersion therapy reduces inflammation and pain associated with gout arthritis. However, cold-water immersion therapy has not been conducted among people worldwide with gout arthritis. Objective: To investigate the cold-water immersion intervention on pain, joint mobility, physical activity, stress, anxiety, depression, and quality of life among acute gout patients. Methods: A community-based randomized control trial design with two parallel-intervention groups: a cold-water immersion group (20-30°C 20minutes/day for 4weeks) and a control group. In total, 76 eligible participants in Tomohon City, Indonesia, were recruited using a multi-stage sampling method and were randomly assigned using block randomization. A generalized estimating equation model was used to analyze the results (coef. β) and produce 95% confidence intervals (CIs). A path analysis was used to analyze mediating effects. Results: Significant pain alleviation (β = -2.06; -2.42), improved joint mobility (β = 1.20, 1.44), physical activity (β = 2.05, .59), stress (β = -1.25; -1.35), anxiety (β = -.62; -1.37), and quality of life (β = 5.34; 9.93) were detected after cold-water immersion at the second-week, and were maintained to the fourth-week time point, compared to pre-intervention and the control group. Depression (β = -1.80) had decreased by the fourth week compared to the pre-test and control group. Cold-water immersion directly mediated alleviation of pain (β = -.46, p ≤ .001) and to promote the quality of life (β = .16, p = .01). Conclusions: Cold-water immersion decreased pain, stress, anxiety, and depression, and increased joint mobility, physical activity, and quality of life. It mediated alleviation of pain to increase the quality of life.

Effect of Personalized Human-Centered Dietary Decision Support System (PHCDDSS) on Dietary Knowledge, Attitude, Practice (KAP), and Mean Fasting Blood Sugar (FBS) Among Participants with Type 2 Diabetes Mellitus (T2DM) in Community-Based Settings of Northern State of India

Introduction: Acknowledging the promising role of information and technology, a study was planned to determine the effect of personalized human-centered dietary decision support system (PHCDDSS) on dietary knowledge, attitude, practice (KAP), and mean fasting blood sugar (FBS) among participants with type 2 diabetes mellitus (T2DM). Materials and Methods: A community-based randomized control trial was conducted among 400 individuals with T2DM randomized into the 12-month intervention group (PHCDDSS) and 400 to the control (usual care) group. Results: In the control and intervention groups, 84.7% and 87.0% participants completed the follow-up at the end of 12 months. Mean knowledge score showed a significant (P = 0.00) declining trend (from 28.3 to 22.2) in the control group, but increasing (from 28.9 to 35.4) in the intervention group. Unlike knowledge, mean attitude score observed a significant declining trend in both the groups but less in the intervention group. The mean FBS (in mg/dL) trend was found to be insignificantly declining in control (199.2–195.4) and intervention (194.8–183.1) groups but the decline was relatively less in control when compared with the intervention group. Conclusion: In study participants, PHCDDSS proved to be effective in improving knowledge and attitude toward role of diet in managing T2DM. The intervention showed promising effect in reduction of mean FBS and proportion of individuals with sugar control.

Effectiveness of WASH Education to Prevent Diarrhea among Children under five in a Community of Patuakhali, Bangladesh

Diarrhea is a leading cause of death among under five children in developing countries. The burden of child diarrhea in Bangladesh is still significant. Safe water, sanitation, and hygiene (WASH) can limit the events. This study aimed to assess the effectiveness of WASH education of mothers or caregivers on child diarrhea. A community-based randomized control trial was conducted in the selected households of a rural community in Dumki Upazila, Patuakhali from March–June 2019. A total of 202 mothers/caregivers received intervention and 202 did not receive intervention. A pre-structured questionnaire was used to gather information on household WASH activities and diarrheal cases. Baseline data were collected first from the intervention group before providing education. WASH messages were given to the intervention group by face-to-face discussion. Both groups were followed up for diarrheal episodes for 3 months. Diarrheal prevalence of intervening group is compared with that of baseline and control. The results revealed that diarrheal prevalence was 11.4% (95% CI: 7.4–16.59%), 4.0% (95% CI: 1.7–7.65%), and 14.9% (95% CI: 10.25–20.52%) in baseline, intervention, and control group, respectively. Also, diarrhea was found lower in the intervention group than baseline (Z = − 2.524; P value = 0.012) and control (Z = − 1.85; P value = 0.04). WASH interventions were found effective to reduce the diarrheal episodes among under five children in rural community. Further investigation is necessary to assess the long-term effect of such intervention in other similar settings.

Improve: A community-based physical activity intervention to improve functional and health outcomes in older breast cancer survivors: Rationale, design, and methods.

TPS11629 Background: African-Americans (AA) and lower socioeconomic status (SES) older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. Promotion of healthy behaviors, such as physical activity (PA), is critical to addressing these health disparities. Here we describe the rationale, design and methods of a randomized controlled trial testing the effectiveness of a physical activity intervention among older BCS from diverse racial and SES backgrounds. Methods: The IMPROVE Study is a community-based randomized-controlled trial designed to recruit 320 BCS, 80 in each of four strata defined by race (AA vs. Non-Hispanic Whites [NHW]) and SES (low vs. high). Participants are aged ≥ 65 years, AA or NHW and are within five years from treatment completion for stage I-III breast cancer. Participants are recruited utilizing the Ohio Cancer Incidence and Surveillance System database or directly from three area hospitals in Cleveland, Ohio and randomized to one of two arms: a 52-week moderate intensity aerobic and resistance group training intervention (n = 160) versus attention-control (support group sessions), (n = 160). The first 20 weeks of the PA intervention includes 3x per week 60-minute supervised sessions. The last 32 weeks of the PA intervention are unsupervised. Each of the 60-minute supervised PA sessions include 30 minutes of moderate intensity aerobic activity at 50%-70% of HRmax (maximum heart rate) and 30 minutes of resistance training based on 1-RM (repetition maximum) for chest and leg press. The attention-control group attend a once per week 60-minute support group session for the first 20 weeks and have unsupervised group sessions during the last 32 weeks. Exit interviews are being conducted at 52 weeks. The primary outcome is change in Short Physical Performance Battery (SPPB) Scores at 20 weeks. Secondary outcomes include change in SPPB scores at 52 weeks, and change in body composition and biomarkers of breast cancer prognosis at 20 and 52 weeks. One hundred and seventy-four participants have been enrolled as of 02/07/2019. Discussion: This study includes three underserved populations, (older BCS in general, older AA BCS and older low SES BCS) in one study. Results may contribute to a better understanding of factors associated with recruitment, sustained participation and acceptability, and will inform physical activity programs that will optimally improve the functional and health outcomes for older women during breast cancer survivorship. Clinical trial information: CNCT02763228.

Results from a randomized trial evaluating a hospital–school transition support model for students hospitalized with traumatic brain injury

ABSTRACTObjective: To evaluate the utility of the STEP model, a systematic hospital–school transition protocol for children hospitalized for TBI.Setting: Five children’s hospitals in Colorado, Ohio, and Oregon.Participants: Hundred families of children with mild, complicated mild, moderate, or severe TBI.Design: Randomized controlled trial (RCT); participants were randomized while hospitalized to the STEP (a standardized hospital–school transition protocol for children treated for TBI) or usual care condition.Main Measures: Questionnaire about child’s special education eligibility status, support services, and academic accommodations; Achenbach Child Behaviour Checklist (CBCL); Behaviour Rating Inventory of Executive Function (BRIEF); Child and Adolescent Scale of Participation (CASP); Child and Adolescent Scales of Environment (CASE)Results: There were no significant effects, indicating that STEP participants did not differ from usual care participants on any study outcome at one month post-discharge or at one-year follow-up.Conclusion: The lack of significant findings in this study does not imply that effective hospital-to-school transition programming is unnecessary. Rather, the findings raise important questions regarding timing and dosage/intensity of intervention, appropriate measurement of outcomes, and fidelity of programme delivery. The study highlights difficulties involved in the conduct of community-based RCTs in the paediatric TBI population.

Evaluating the Recombinant T24H Enzyme-Linked Immunoelectrotransfer Blot Assay for the Diagnosis of Neurocysticercosis in a Panel of Samples from a Large Community-Based Randomized Control Trial in 60 Villages in Burkina Faso.

Current guidelines for the diagnosis of neurocysticercosis (NCC) recommend the use of the lentil lectin-bound glycoprotein enzyme-linked immunoelectrotransfer blot assay (LLGP-EITB) as the reference standard for serological testing. In response to the drawbacks involved with the use of the LLGP-EITB, a recombinant T24H antigen (rT24H) EITB assay was developed, with promising results. However, the test has yet to be evaluated among individuals from sub-Saharan Africa (SSA). The aim of the present study was to investigate the performance of the rT24H EITB assay for the detection of NCC cases in a panel of serum samples (N = 366, of which 173 patients presented with epileptic seizures and/or severe chronic headaches, and 193 matched manifestation-free participants) collected as part of a large community-based trial in Burkina Faso. A perfect agreement between the rT24H EITB and the native gp24 (and its homodimer, gp42) LLGP-EITB was found (kappa value of 1.0). Furthermore, among patients with the neurological manifestations of interest who underwent a computed tomography scan, the rT24H EITB and native antigen LLGP-EITB had a comparable ability to correctly identify NCC cases with multiple viable (rT24H: sensitivity: 80.0%), single viable (66.7%), and calcified/degenerating cysts only (25.0%), albeit for multiple viable and calcified cysts, the rT24H estimated sensitivity seemed lower, but more uncertain, than previously reported. The rT24H EITB specificity was high (98.2%) and in line with previous studies. This study confirms the value of the recombinant rT24H EITB as an alternative to the native antigen LLGP-EITB for the diagnosis of NCC in a SSA community setting.

The role of mHealth intervention on maternal and child health service delivery: findings from a randomized controlled field trial in rural Ethiopia.

The provision of consistent and quality maternal and child health (MCH) services is a challenge for Ethiopia where most of the population lives in the rural setup. Health service delivery is constrained mainly by shortage of health professionals, meager resources, limited awareness among the society and bureaucratic procedures. Low health service utilization of antenatal care (ANC), delivery services, and postnatal care (PNC) are believed to contribute for high maternal and child mortality rates. Innovative approach like mHealth based technological intervention believed to alleviate such challenges in countries like ours. However, currently, there are few evidences that demonstrate the impact of mHealth technology applications on the level of service utilization. Therefore, the objective our study is to assess the role of mobile phone equipped with short message service (SMS) based data-exchange software linking community health workers to Health Centers in rural Ethiopia affect selected MCH outcomes. A community-based randomized control trial (RCT) was conducted in three woredas of Guraghe zone (Ezha, partial &Abeshge full intervention, Sodo Control). Mobile phones equipped with FrontlineSMS based, locally developed application was distributed to all health extension workers (HEWs) to both intervention woredas who filled maternal, child and stock related forms and submitted to the central server which in turn sends reminder about the scheduled date of ANC visit, expected date of delivery, PNC, immunization schedule and vaccine and contraceptive stock status. Moreover, in Abeshge, the voluntary health workers (vCHW) and HEW supervisors in both intervention woreda were given a phone to facilitate communication with the HEW. No mobile was offered to the control woreda.Pre [2012] and post [2013] intervention community based survey on mothers who have under 5 and under 1 year old child was done to assess the effect of the mobile intervention on selected MCH process indicators. Structured and pretested questionnaire was used to collect data and SPSS v16 statistical software was used for analysis. Three thousand two hundred and forty mothers, 1,080 from each, were surveyed in the three woredas. The study revealed that the proportion of mothers receiving more than four ANC visits increased significantly in both intervention woredas. Besides, the rate of ANC delivered by HEWs improved in Ezha woreda (T1) (19.01% to 28.27%), proportions of deliveries attended by skilled health workers increased and home delivery decreased in all woredas; most pronounced increases in referrals from health post to health center by HEWs, reported in Ezha and Abeshge. The intervention also led to a significant reduction in stock-outs of preferred contraceptive products in Ezha (T1) from 16.96% to 8.24% but no change was observed in both contraceptive prevalence and immunization rates in the control and the other intervention woreda. The study confirmed the positive contribution of SMS based mobile phone intervention in most of the selected MCH service indicators, like improvement in the percent of recommended number of ANC visit, percentage of delivery attended by health workers and facilitating the work processes of the health workers in rural Ethiopia.

A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children.

We conducted a study to evaluate the effectiveness of Mom Power, a multifamily parenting intervention to improve mental health and parenting among high-risk mothers with young children in a community-based randomized controlled trial (CB-RCT)design. Participants (N=122) were high-risk mothers (e.g., interpersonal trauma histories, mental health problems, poverty) and their young children (age <6years), randomized either to Mom Power, a parenting intervention (treatment condition), or weekly mailings of parenting information (control condition). In this study, the 13-session intervention was delivered by community clinicians trained to fidelity. Pre- and post-trial assessments included mothers' mental health symptoms, parenting stress and helplessness, and connection to care. Mom Power was delivered in the community with fidelity and had good uptake (>65%) despite the risk nature of the sample. Overall, we found improvements in mental health and parenting stress for Mom Power participants but not for controls; in contrast, control mothers increased in parent-child role reversal across the trial period. The benefits of Mom Power treatment (vs. control) were accentuated for mothers with interpersonal trauma histories. Results of this CB-RCT confirm the effectiveness of Mom Power for improving mental health and parenting outcomes for high-risk, trauma-exposed women with young children. ClinicalTrials.gov Identifier: NCT01554215.

Promoting First Relationships®: Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services.

We conducted a community-based randomized control trial with intent-to-treat analysis on Promoting First Relationships® (PFR), a 10-week home visiting program. The study included 247 families with 10- to 24-month-old children who had a recent, open child protective services investigation of child maltreatment. Families were randomly assigned to receive either the 10-week home visiting PFR service or a telephone-based, three-call resource and referral (R&R) service. Across postintervention time points, parents in the PFR condition scored higher than families in the R&R condition in parent understanding of toddlers' social emotional needs ( d = .35) and observed parental sensitivity ( d = .20). Children in the PFR condition scored lower than children in the comparison condition on an observational measure of atypical affective communication ( d = .19) and were less likely than children in the comparison group to be placed into foster care through 1-year postintervention (6% vs. 13%, p = .042). No significant differences were found on measures of parenting stress or child social-emotional competence, behavior problems, or secure base behavior. Overall, the results show support for the promise of PFR as an intervention for enhancing parent sensitivity and preventing child removals for families in the child welfare system.

Self-Report Versus Medical Record for Mammography Screening Among Minority Women.

Self-report is the most common means of obtaining mammography screening data. The purpose of this study was to assess the accuracy of minority women's self-reported mammography by comparing their self-reported dates of mammograms with those in their medical records from a community-based randomized control trial. We found that out of 192 women, 116 signed the Health Information Portability and Accountability Act form and, among these, 97 had medical records that could be verified (97 / 116 = 83.6%). Ninety-two records matched where both sources confirmed a mammogram; 48 of 92 (52.2%) matched perfectly on self-reported date of mammogram. Complexities in the verification process warrant caution when verifying self-reported mammography screening in minority populations. In spite of some limitations, our findings support the usage of self-reported data on mammography as a validated tool for other researchers investigating mammography screening among minority women who continue to have low screening rates.

Development of a Community-Based Fall Prevention Program: Stay in Balance

Falls and fall-related injuries are critical issues for older adults; evidence indicates that multidimensional interventions that address modifiable risk factors can be successful in reducing falls. Few evidence-based fall prevention interventions exist due, in part, to complex issues associated with development and implementation. There is a need for a variety of such programs from which older adults may choose. We describe steps, outcomes, and issues involved in developing/implementing an evidenced-based fall prevention program in community settings. The Stay In Balance program (SIB), developed by a team of professionals, local service providers and active older adults, was carried out with total of 135 older adults in several steps: developing objectives and program content, laboratory-based randomized controlled trial (RCT), pilot program in the community, community-based RCT, and implementation at 2 community sites. Each step in development provided useful and different insights into needed changes in program content, equipment, support materials, training, and appropriate outcome measures. Development of an evidenced-based fall prevention program requires a long term commitment on the part of all partners, University personnel, local service providers, and older adult participants; funding is also critical.

Secular trends and smoke-free policy development in rural Kentucky.

Secondhand smoke (SHS) exposure causes cardiovascular disease, lung cancer and pulmonary disorders. Smoke-free policies are the most effective way to prevent exposure to SHS. A 5-year community-based randomized control trial (RCT) is in progress to assess factors associated with smoke-free policy development in rural communities. Considering secular trends is critical when conducting community-based RCTs as they may threaten the internal validity of the study. For the purposes of this paper, secular trends are defined as patterns or recurring events that are not directly related to smoke-free policy but have the potential to influence policy development. There are no established protocols to monitor secular trends in the study of smoke-free policy in rural communities. The purpose of this paper is to (i) describe the development of a protocol to identify and monitor secular trends that may threaten the internal validity of a community-based RCT to promote smoke-free policy development and (ii) describe secular trends identified in the first 2 years of the RCT. The sample includes 854 secular events captured from media outlets covering the 40 study counties over the first 2 years of the RCT. Of these 854 events, there were 281 secular events in Year 1 and 573 in Year 2. This paper focuses on five specific categories: 'tobacco use and cessation activities', 'farming', 'economics', 'city/county infrastructure' and 'wellness'. This protocol is a feasible yet time-intensive method of identifying events that may threaten the internal validity of a community-based RCT.

Does improving maternal knowledge of vaccines impact infant immunization rates? A community-based randomized-controlled trial in Karachi, Pakistan

BackgroundIn Pakistan, only 59-73% of children 12-23 months of age are fully immunized. This randomized, controlled trial was conducted to assess the impact of a low-literacy immunization promotion educational intervention for mothers living in low-income communities of Karachi on infant immunization completion rates.MethodsThree hundred and sixty-six mother-infant pairs, with infants aged ≤ 6 weeks, were enrolled and randomized into either the intervention or control arm between August - November 2008. The intervention, administered by trained community health workers, consisted of three targeted pictorial messages regarding vaccines. The control group received general health promotion messages based on Pakistan's Lady Health Worker program curriculum. Assessment of DPT/Hepatitis B vaccine completion (3 doses) was conducted 4-months after enrollment. A Poisson regression model was used to estimate effect of the intervention. The multivariable Poisson regression model included maternal education, paternal occupation, ownership of home, cooking fuel used at home, place of residence, the child's immunization status at enrollment, and mother's perception about the impact of immunization on child's health.ResultsBaseline characteristics among the two groups were similar. At 4 month assessment, among 179 mother-infant pairs in the intervention group, 129 (72.1%) had received all 3 doses of DPT/Hepatitis B vaccine, whereas in the control group 92/178 (51.7%) had received all 3 doses. Multivariable analysis revealed a significant improvement of 39% (adjusted RR = 1.39; 95% CI: 1.06-1.81) in DPT-3/Hepatitis B completion rates in the intervention group.ConclusionA simple educational intervention designed for low-literate populations, improved DPT-3/Hepatitis B vaccine completion rates by 39%. These findings have important implications for improving routine immunization rates in Pakistan.