scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2018 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial

10.2196/18021 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e18021
Author(s):  
Mohammad Owaise Sharif ◽  
Jonathon Timothy Newton ◽  
Susan J Cunningham
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Mobile Phones ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Adherence To Treatment ◽  
Randomized Controlled

Background Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID) PRR1-10.2196/18021

scholarly journals Socio-Ecological Natural Experiment with Randomized Controlled Trial to Promote Active Commuting to Work: Process Evaluation, Behavioral Impacts, and Changes in the Use and Quality of Walking and Cycling Paths

2019 ◽  
Vol 16 (9) ◽  
pp. 1661 ◽  
Author(s):  
Minna Aittasalo ◽  
Johanna Tiilikainen ◽  
Kari Tokola ◽  
Jaana Suni ◽  
Harri Sievänen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Natural Experiment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Active Commuting ◽  
Phase 2 ◽  
Behavioral Strategies ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Journey To Work

Active commuting to work (ACW) has beneficial effects on health, traffic, and climate. However, more robust evidence is needed on how to promote ACW. This paper reports the findings of a multilevel natural experiment with a randomized controlled trial in 16 Finnish workplaces. In Phase 1, 11 workplaces (1823 employees) from Area 1 were exposed to environmental improvements in walking and cycling paths. In Phase 2, five more workplaces (826 employees) were recruited from Area 2 and all workplaces were randomized into experimental group (EXP) promoting ACW with social and behavioral strategies and comparison group (COM) participating only in data collection. Process and impact evaluation with questionnaires, travel diaries, accelerometers, traffic calculations, and auditing were conducted. Statistics included Wilcoxon Signed Ranks Test, Mann-Whitney U-test, and after-before differences with 95% confidence intervals (95% CI). After Phase 1, positive change was seen in the self-reported number of days, which the employees intended to cycle part of their journey to work in the following week (p = 0.001). After Phase 2, intervention effect was observed in the proportion of employees, who reported willingness to increase walking (8.7%; 95% CI 1.8 to 15.6) and cycling (5.5%; 2.2 to 8.8) and opportunity to cycle part of their journey to work (5.9%; 2.1 to 9.7). To conclude, the intervention facilitated employees’ motivation for ACW, which is the first step towards behavior change.

scholarly journals Prevention of developmental delays among children at public healthcare facilities of Pakistan: protocol for a cluster Randomized Controlled Trial

2021 ◽  
Vol 20 (11) ◽  
Author(s):  
Nida Khan ◽  
Muhammad Amir Khan ◽  
Muhammad Ahmar Khan ◽  
Amna Ejaz ◽  
Azza Warraitch ◽  
...  
Keyword(s):  
Public Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Developmental Delays ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Public Health Care ◽  
Public Healthcare ◽  
Randomized Controlled ◽  
Cluster Randomized

Objectives: This cluster Randomized Controlled Trial (cRCT) aims to evaluate the effectiveness of an integrated ECD package in preventing developmental delays among children aged two years, in public health care centers, as compared to a control arm. Methods: This is a parallel, two-arm, cluster randomized controlled trial. 768 mother-child pairs (‘dyads’) attending any of the 24-public health centers in two districts of Pakistan will be recruited, with an average of 32 participants per cluster. In the intervention arm, ECD based counselling sessions will be delivered to mother–child dyads by trained staff at public health care centers. Our primary outcome is reduction in prevalence of two or more developmental delays among children, from 38% to 23% in the intervention arm. Unit of randomization will be public health care center. 24 eligible clusters recruited will be randomized into intervention and control arms, using 1:1 allocation. Discussion: The integrated model of child care into primary health care has the potential to provide a feasible and sustainable model for improving child developmental scale. Key words: Early Child Development; Prevention; Developmental Delays; Public healthcare facilities

scholarly journals Effectiveness of Checklist based Box system Interventions (CBBSI) versus routine care on improving utilization of Maternal Health Service in North West, Ethiopia: Study protocol for a Cluster Randomized Controlled Trial

2019 ◽  
Author(s):  
Netsanet Belete ◽  
Mulusew Gerbaba ◽  
Gurmesa Tura
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Maternal Health ◽  
Health Center ◽  
Controlled Trial ◽  
Maternal Health Service ◽  
Health Extension Workers ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Pregnant Mothers

Abstract Background - Maternal mortality is still high in Ethiopia. Antenatal care, use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low and middle income countries including Ethiopia, utilization of these key services are not enough to deliver the recommended preventive, promotive and curative services. The aim of this study is to examine the effectiveness of checklist based box system interventions on improving maternal health service utilization. Methods - A community level cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist based box system interventions over the routine standard of care. The intervention will use health extension program and provided by health extension workers and midwives, using a special type of health education scheduling and service utilization monitoring boxes, placed at health posts and health centers respectively. For this, 1,200 pregnant mothers, below 16 weeks of gestation, will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. In a two weeks base, review of dropouts will be conducted at each intervention health center. Then intervention health posts (supervised by intervention health center) will be communicated for each dropout. Then, health extension workers will provide health education, using a person-centered manual prepared for this purpose. Data will be collected using ODK-Collect and analyzed using STATA version 13.0. Data will be analyzed by intention to treat analysis. Risk ration will be computed at cluster level and the summary will be compared using t-test. Outcomes between intervention and control groups will be compared with random effects logistic regression models. Discussion - The authors of this study expect that, the study will generate evidence on the effectiveness of checklist based box system interventions on improving utilization of maternal health care service, that are strong enough to inform policies in the country.

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