scholarly journals Meeting the Challenges of Longitudinal Cluster-Based Trials in Schools: Lessons From the Chicago Trial of Positive Action

2016 ◽  
Vol 40 (4) ◽  
pp. 450-482 ◽  
Author(s):  
Kendra M. Lewis ◽  
David L. DuBois ◽  
Peter Ji ◽  
Joseph Day ◽  
Naida Silverthorn ◽  
...  

We describe challenges in the 6-year longitudinal cluster randomized controlled trial (CRCT) of Positive Action (PA), a social–emotional and character development (SECD) program, conducted in 14 low-income, urban Chicago Public Schools. Challenges pertained to logistics of study planning (school recruitment, retention of schools during the trial, consent rates, assessment of student outcomes, and confidentiality), study design (randomization of a small number of schools), fidelity (implementation of PA and control condition activities), and evaluation (restricted range of outcomes, measurement invariance, statistical power, student mobility, and moderators of program effects). Strategies used to address the challenges within each of these areas are discussed. Incorporation of lessons learned from this study may help to improve future evaluations of longitudinal CRCTs, especially those that involve evaluation of school-based interventions for minority populations and urban areas.

2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  

BACKGROUND Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. OBJECTIVE The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. METHODS Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. RESULTS We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. CONCLUSIONS Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. CLINICALTRIAL ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24407


2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal. Methods: We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NU rse-led CO ntinuum of care for people with D iabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD) , with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis. Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. https://bit.ly/34qwIAd


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 169-169
Author(s):  
Jennifer Jarvey Balistreri ◽  
Cathy Schulz ◽  
Anne Marie Barry-Weers ◽  
James L. Weese

169 Background: HPV infection is the most common sexually transmitted disease. Exposure to this infection is associated with cancer later in life. Public data regarding HPV vaccination rates and health disparity (as evidenced by low-income, high teen birth and STI rates) were identified. Methods: Based on the supposition that health disparity is associated with low socioeconomic status, a Wisconsin state map provided by the Center for Urban Population Health identified 29 zip codes in the City of Milwaukee, and are broken by low, medium, and high income brackets. An HPV education program, in partnership with Milwaukee Public Schools (MPS), was developed with a focus on the low income bracket to emphasize infection exposure and the safety and efficacy of the HPV vaccine in cancer prevention. This included education on safe relationships and emphasis on personal health advocacy. Program development was aimed at the health literacy of youth. Collaboration occurred with MPS leadership and their established health curriculum to ensure the HPV program accommodated the academic level of the freshman health classroom. Results: The data is reflective of HPV vaccine series completion rates within the zip codes where the HPV program was presented. Logistic regression was used and a significant rise for HPV completion rates by year (p = 0.0003) and by zip code (p < 0.0001) were observed. Conclusions: As the program evolves, program evaluations and public data continue to be reviewed along with feedback from various stakeholders to maintain the quality and integrity of the program. Additionally, Aurora Health Care has received requests to share this HPV program best practice with other institutions to expand it throughout urban areas of Wisconsin and Illinois.[Table: see text]


Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Katie Crist ◽  
Fatima Tuz Zahra ◽  
Kelsie M Full ◽  
Marta M Jankowska ◽  
Loki Natarajan

Objective: Older adults are the least active population group in the U.S. Low income and ethnically diverse communities have fewer physical activity (PA) related resources and facilities, which contributes to lower PA levels and disparities in cardiovascular (CVD) risk factors and disease outcomes. This study assessed the hypothesis that low income and diverse older adults participating in the multilevel Peer Empowerment Program 4 Physical Activity (PEP4PA) would increase moderate-to-vigorous PA (MVPA), improve blood pressure (BP), perceived quality of life (PQoL), and depressive symptoms to a greater extent than older adults receiving usual senior center programming. Methods: In a cluster-randomized controlled trial (RCT) in 12 senior centers, 476 older adults (mean age 71.4 years, 76% female, 60% low income, 38% minority) were assigned to a PA intervention (n=267) or control (n=209) condition. The peer-led intervention included individual self-monitoring and counseling, group walks and social support, and community advocacy to improve walking conditions. Outcomes included minutes of MVPA per day (7-day accelerometer), systolic and diastolic BP (automatic cuff), PQoL (PQoL-20) and depressive symptoms (CES-D 10) at baseline, 6, 12, 18 and 24 months. To account for multiple measurement days and clustering of participants within senior centers, mixed effects regression models with random effects estimated the intervention effects on all outcomes between groups over time. Models were adjusted for imbalanced baseline covariates. A three-way interaction term assessed whether intervention effects differed by income status. Results: Compared to the control group, intervention participants significantly increased MVPA from baseline at 6, 12, 18 and 24 months by 8, 11, 9 and 9 minutes/day respectively (p<0.001), with increases remaining statistically significant across the 2-year period. The intervention group significantly increased mean PQoL scores from 7.2 at baseline to 7.6 (p<0.001), 7.8 (p=0.008) and 7.7 (p<0.001) at 12, 18 and 24 months, compared to control participants. No significant effects were observed for BP or depressive symptoms. Low income participants decreased minutes of MVPA, compared to higher income participants, at 12 and 24 months (β=-7.9, p=0.008 and β=-10.8, p=0.001). Conclusions: The multilevel RCT achieved sustained increases in MVPA and QoL in a diverse cohort of older adults across 2 years of follow up. The peer-led, community-based intervention provides a sustainable model to improve health behaviors related to CVD in an at-risk and often difficult to reach aging population. Further exploration is needed to understand what components of the intervention may be modified to address the differential effects by income status.


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