Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561126
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors EMPOWER-D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors EMPOWER-D Cluster Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to adapt implement and evaluate Participatory Learning and Action PLA based intervention in rural areas of KPK Pakistan which includes Peshawar and Swabi for TIIDM prevention and control The pivotal components of this approach include adapting implementing and evaluating the PLA-based intervention for the prevention and control of Type II diabetes These components will be tailored to meet the specific needs of two different settings in Peshawar and Swabi Pakistan
Type II Diabetes Mellitus TIIDM is considered the fastest-growing health emergency affecting 537 million adults worldwide Global projections for the year 2045 suggest that a 122 rise in TIIDM is anticipated with an additional 114 rise for intermediate hyperglycemia IHG 1 Around 80 of people with TIIDM reside in low-and middle-income countries LMICs exhausting the already burdened healthcare system 2 The intervention Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh DMagic has been tested and found effective in the rural context of Bangladesh 1-3 A full trial will be conducted in the rural areas of Peshawar and Swabi Pakistan
It is anticipated that with the use of evidence-based approaches best practices and meaningful community participation PLA is expected to enhance social and behavioural determinants of health and subsequent outcomes This will further pave the way for the control of other NCDs through a similar focused approach
Type II Diabetes Mellitus TIIDM is considered the fastest-growing health emergency affecting 537 million adults worldwide Global projections for the year 2045 suggest that a 122 rise in TIIDM is anticipated with an additional 114 rise for intermediate hyperglycemia IHG 1 Around 80 of people with TIIDM reside in low-and middle-income countries LMICs exhausting the already burdened healthcare system 2 The intervention Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh DMagic has been tested and found effective in the rural context of Bangladesh 1-3 A full trial will be conducted in the rural areas of Peshawar and Swabi Pakistan
It is anticipated that with the use of evidence-based approaches best practices and meaningful community participation PLA is expected to enhance social and behavioural determinants of health and subsequent outcomes This will further pave the way for the control of other NCDs through a similar focused approach
Detailed Description:
The PLA approach has been systematized into a community approach where groups meet together and follow a cycle of activities This cycle involves problem identification collaborative strategy planning implementation and participatory evaluation To address community health issues various strategies including photo voice group discussions and role-play have been widely utilized By leveraging their life experiences individuals are encouraged to actively participate in these activities empowering them to identify problems and utilize their skills to develop effective solutions
Scientific evidence has demonstrated PLA to be a cost-effective technique to increase maternal and neonatal survival in low-resource settings like India and Nepal Moreover it increased awareness about birth preparedness improved newborn care practices and enhanced male participation in maternal and newborn health
This study will utilize a community group-based PLA approach to tackle TIIDM adapted from D-Magic Bangladesh A cluster randomized controlled trial will be conducted to assess the effectiveness of PLA in addressing TIIDM and pre-diabetes in rural areas of Peshawar and Swabi Pakistan The PLA approach is instrumental in improving health outcomes and services by fostering collaborative community efforts and empowering the community This collaborative approach fosters a sense of unity inclusivity and shared responsibility ultimately contributing to improved health outcomes and the overall well-being of the community However despite its significant impact PLA has not been adapted or tested in settings elsewhere for the prevention and control of TIIDM
Objective
1 To culturally adapt PLA-based intervention DMagic for primary prevention and control of TIIDM in rural communities of Pakistan
2 To assess the effectiveness of culturally adapted PLA-based intervention adapted from D-Magic trial Bangladesh on the two-year cumulative incidence of TIIDM in high-risk individuals and the prevalence of IHG and TIIDM in rural settings
3 To determine the cost-effectiveness of the adapted DMagic intervention in rural settings of Pakistan
Scientific evidence has demonstrated PLA to be a cost-effective technique to increase maternal and neonatal survival in low-resource settings like India and Nepal Moreover it increased awareness about birth preparedness improved newborn care practices and enhanced male participation in maternal and newborn health
This study will utilize a community group-based PLA approach to tackle TIIDM adapted from D-Magic Bangladesh A cluster randomized controlled trial will be conducted to assess the effectiveness of PLA in addressing TIIDM and pre-diabetes in rural areas of Peshawar and Swabi Pakistan The PLA approach is instrumental in improving health outcomes and services by fostering collaborative community efforts and empowering the community This collaborative approach fosters a sense of unity inclusivity and shared responsibility ultimately contributing to improved health outcomes and the overall well-being of the community However despite its significant impact PLA has not been adapted or tested in settings elsewhere for the prevention and control of TIIDM
Objective
1 To culturally adapt PLA-based intervention DMagic for primary prevention and control of TIIDM in rural communities of Pakistan
2 To assess the effectiveness of culturally adapted PLA-based intervention adapted from D-Magic trial Bangladesh on the two-year cumulative incidence of TIIDM in high-risk individuals and the prevalence of IHG and TIIDM in rural settings
3 To determine the cost-effectiveness of the adapted DMagic intervention in rural settings of Pakistan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None