Preventing obesity among adolescent girls in low-income secondary schools: One-year outcomes of the NEAT Girls cluster randomized controlled trial

2012 ◽  
Vol 6 ◽  
pp. 39
Author(s):  
D. Lubans ◽  
P. Morgan ◽  
A. Okely ◽  
D. Dewar ◽  
C. Collins ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Secondary Schools ◽  
Adolescent Girls ◽  
Low Income ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
One Year

scholarly journals Nurse-led continuum of care for people with diabetes and pre-diabetes in Nepal (NUCOD): study protocol for a cluster randomized controlled trial

2020 ◽  
Author(s):  
Dong (Roman) Xu ◽  
Rubee Dev ◽  
Abha Shrestha ◽  
Lingling Zhang ◽  
Archana Shrestha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Continuum Of Care ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Implementation Outcomes ◽  
Cluster Randomized

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

scholarly journals Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

10.2196/15314 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e15314
Author(s):  
Sujha Subramanian ◽  
Patrick Edwards ◽  
Sarah T Roberts ◽  
Maurice Musheke ◽  
Michael Mbizvo
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Adolescent Girls ◽  
Young Women ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Depth Interviews

Background Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. Objective The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. Methods We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. Results Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. Conclusions This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. Trial Registration ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953 International Registered Report Identifier (IRRID) PRR1-10.2196/15314

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