scholarly journals A youth empowerment intervention to prevent childhood obesity: design and methods for a cluster randomized trial of the H2GO! program

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Monica L. Wang ◽  
Linda S. Sprague Martinez ◽  
Janice Weinberg ◽  
Selenne Alatorre ◽  
Stephenie C. Lemon ◽  
...  
Keyword(s):  
Childhood Obesity ◽  
Randomized Trial ◽  
Low Income ◽  
Retention Rate ◽  
Ethnically Diverse ◽  
Cluster Randomized Trial ◽  
Academic Community ◽  
Youth Empowerment ◽  
Cluster Randomized ◽  
Design And Methods

Abstract Background Reducing sugar-sweetened beverage (SSB) consumption is a promising dietary target for childhood obesity prevention. This paper describes the design and methods of a cluster randomized trial of H2GO!, a youth empowerment intervention to prevent childhood obesity through reducing SSB consumption among a low-income, ethnically diverse sample of youth. Methods This cluster randomized controlled trial is an academic-community partnership with the Massachusetts Alliance of Boys and Girls Clubs (BGC). Ten BGC sites will be randomly assigned to the H2GO! intervention or a wait-list, usual care control. Eligible study participants will be N = 450 parent-child pairs (youth ages 9–12 years and their parents/caregivers) recruited from participating BGCs. The 6-week in-person H2GO! intervention consists of 12 group-based sessions delivered by BGC staff and youth-led activities. An innovative feature of the intervention is the development of youth-produced narratives as a strategy to facilitate youth empowerment and parental engagement. Child outcomes include measured body mass index z scores (zBMI), beverage intake, and youth empowerment. Parent outcomes include beverage intake and availability of SSBs at home. Outcomes will be measured at baseline and at 2, 6, and 12 months. With a 75% retention rate, the study is powered to detect a minimum group difference of 0.1 zBMI units over 12 months. Discussion Empowering youth may be a promising intervention approach to prevent childhood obesity through reducing SSB consumption. This intervention was designed to be delivered through BGCs and is hypothesized to be efficacious, relevant, and acceptable for the target population of low-income and ethnically diverse youth. Trial registration ClinicalTrials.gov NCT04265794. Registered 11 February 2020.

scholarly journals Design and rationale of the Longitudinal Evaluation of Norms and Networks Study (LENNS): A cluster-randomized trial assessing the impact of a norms-centric intervention on exclusive toilet use and maintenance in peri urban communities of Tamil Nadu

2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G. Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  
Keyword(s):  
Behavior Change ◽  
Randomized Trial ◽  
Low Income ◽  
Tamil Nadu ◽  
Cluster Randomized Trial ◽  
List Type ◽  
Behavior Change Intervention ◽  
Ex Ante ◽  
Cluster Randomized ◽  
The Impact

AbstractIntroductionInconsistent 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 norms-centric behavior change interventions to increase toilet use in low-income settings. This protocol details the rationale and design of an ex-ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norms-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.Methods and AnalysisFollowing two years of formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “Our wellbeing”). The multi-level intervention aims to shift collective beliefs 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 build, consistently use and maintain their toilets. This trial includes 76 wards in Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining serve as counterfactuals. During baseline and endline (conducted one year after the initiation of intervention) assessments, we collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, wellbeing outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We will also conduct a process evaluation to understand the extent to which the intervention was implemented, as designed.Ethics and DisseminationThe study protocol has been reviewed and approved by the ethics board at the University of Pennsylvania, USA and the Catalyst Foundation, India. Research findings will be disseminated through open access peer reviewed publications and presentations to stakeholders, government officials and conferences.Trial registrationNCT04269824.Strengths and limitations of this studyThis ex-ante, parallel cluster randomized trial assesses the impact of a norm-centric behavior change intervention strategy to improve sanitation practices. These behavior change techniques are novel to the sanitation sector but has been effective in changing a variety of behaviors, such as water use, drinking behavior, and energy consumption.The study outcomes include health, wellbeing outcomes, and a careful assessment of changes in social beliefs, expectations, and social determinants of collective sanitation behaviors.This study is being rolled out during the ongoing COVID-19 pandemic. This can potentially impact the effectiveness of this intervention package that uses community and network-based group activities. However, through a detailed process monitoring and evaluation we will be able to assess the impact on delivery, and subsequent behavior change in this unique setting.

scholarly journals Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda

2019 ◽  
pp. 1-13
Author(s):  
Lydia E. Pace ◽  
Jean Marie Vianney Dusengimana ◽  
Lawrence N. Shulman ◽  
Lauren E. Schleimer ◽  
Cyprien Shyirambere ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Low Income ◽  
Early Stage ◽  
Cluster Randomized Trial ◽  
Early Stage Disease ◽  
Catchment Areas ◽  
Hospital Visits ◽  
Cluster Randomized ◽  
The Impact

PURPOSE Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P = .001) and 7.9 visits/month for phase 2 HCs ( P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P < .001) and biopsies (36.6 v 8.9/100,000 person-years, P < .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.

scholarly journals Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
A. K. Lofters ◽  
M. A. O’Brien ◽  
R. Sutradhar ◽  
A. D. Pinto ◽  
N. N. Baxter ◽  
...  
Keyword(s):  
Public Health ◽  
Chronic Disease ◽  
Disease Prevention ◽  
Randomized Trial ◽  
Low Income ◽  
Cluster Randomized Trial ◽  
Chronic Disease Prevention ◽  
Evidence Based ◽  
Wait List ◽  
Cluster Randomized

Abstract Background The BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) intervention was designed to integrate the approach to chronic disease prevention and screening in primary care and demonstrated effective in a previous randomized trial. Methods We tested the effectiveness of the BETTER HEALTH intervention, a public health adaptation of BETTER, at improving participation in chronic disease prevention and screening actions for residents of low-income neighbourhoods in a cluster randomized trial, with ten low-income neighbourhoods in Durham Region Ontario randomized to immediate intervention vs. wait-list. The unit of analysis was the individual, and eligible participants were adults age 40–64 years residing in the neighbourhoods. Public health nurses trained as “prevention practitioners” held one prevention-focused visit with each participant. They provided participants with a tailored prevention prescription and supported them to set health-related goals. The primary outcome was a composite index: the number of evidence-based actions achieved at six months as a proportion of those for which participants were eligible at baseline. Results Of 126 participants (60 in immediate arm; 66 in wait-list arm), 125 were included in analyses (1 participant withdrew consent). In both arms, participants were eligible for a mean of 8.6 actions at baseline. At follow-up, participants in the immediate intervention arm met 64.5% of actions for which they were eligible versus 42.1% in the wait-list arm (rate ratio 1.53 [95% confidence interval 1.22–1.84]). Conclusion Public health nurses using the BETTER HEALTH intervention led to a higher proportion of identified evidence-based prevention and screening actions achieved at six months for people living with socioeconomic disadvantage. Trial registration NCT03052959, registered February 10, 2017.

scholarly journals First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Elizabeth M McClure ◽  
Robert O Nathan ◽  
Sarah Saleem ◽  
Fabian Esamai ◽  
Ana Garces ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Low Income ◽  
Pregnancy Outcomes ◽  
Cluster Randomized Trial ◽  
Income Country ◽  
Low Income Country ◽  
Cluster Randomized
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