Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

Официальное название

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

Обзор

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 12.2% rise in TIIDM is anticipated with an additional 11.4% 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.

Подробное описание

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.

Вмешательства

• Поведенческое Participatory, Learning and Action Based Intervention
  The total number of participants exposed to the intervention (adapted from the DMagic trial in Bangladesh) will be determined based on random selection from the community. A PLA-based intervention would be carried out to prepare the Diabetes Mellitus type II patients. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the type II diabetes mellitus. The study participants would be evaluated after 18 months of the intervention. A structured, validated and literat

Первичные конечные точки

• Prevalence of Type 2 Diabetes Mellitus [Срок оценки: 18 months]
• Prevalence of Intermediate Hyperglycemia (IHG) [Срок оценки: 18 months]
• 2-year cumulative incidence of Type 2 Diabetes Mellitus [Срок оценки: 18 months]

Вторичные конечные точки (9)

• Blood pressure (BP) [Срок оценки: 18 months]
• Prevalence of hypertension [Срок оценки: 18 months]
• Abdominal obesity [Срок оценки: 18 months]
• Body mass index (BMI) [Срок оценки: 18 months]
• Prevalence of overweight & obesity [Срок оценки: 18 months]
• Depression [Срок оценки: 18 months]
• Body fat composition [Срок оценки: 18 months]
• Quality of life of type II diabetes mellitis & Intermediate Hyperglycemia patients [Срок оценки: 18 months]
• Anxiety [Срок оценки: 18 months]

Критерии участия

Критерии включения

• Individuals aged 20 years and above.
• Participants residing in the rural areas of Peshawar and Swabi, Pakistan.
• Individuals willing to participate in the study and provide consent.
• Both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate.
• Participants who can attend the scheduled meetings and interventions as per the study protocol.

Критерии исключения

• Individuals below the age of 20 years.
• Individuals unwilling to provide consent for participation.
• Participants with severe health conditions that may hinder their active involvement in the study.
• Individuals with a history of non-compliance with medical interventions or research protocols

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Khyber Medical University Peshawar — Peshawar

Публикации

• Lam AA, Lepe A, Wild SH, Jackson C. Diabetes comorbidities in low- and middle-income countries: An umbrella review. J Glob Health. 2021 Jul 24;11:04040. doi: 10.7189/jogh.11.04040. eCollection 2021. PMID 34386215
• Fottrell E, Ahmed N, Morrison J, Kuddus A, Shaha SK, King C, Jennings H, Akter K, Nahar T, Haghparast-Bidgoli H, Khan AKA, Costello A, Azad K. Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):200-212. doi: 10.1016/S2213-8587(19)30 PMID 30733182
• Lee YL, Lim YMF, Law KB, Sivasampu S. Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension. Trials. 2020 Jun 16;21(1):530. doi: 10.1186/s13063-020-04349-4. PMID 32546189
• Martin J, Girling A, Nirantharakumar K, Ryan R, Marshall T, Hemming K. Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care. Trials. 2016 Aug 15;17:402. doi: 10.1186/s13063-016-1532-9. PMID 27524396
• Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53. PMID 22952508
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941
• Sapra A, Bhandari P, Sharma S, Chanpura T, Lopp L. Using Generalized Anxiety Disorder-2 (GAD-2) and GAD-7 in a Primary Care Setting. Cureus. 2020 May 21;12(5):e8224. doi: 10.7759/cureus.8224. PMID 32582485
• Ullah I, Islam MS, Ali S, Jamil H, Tahir MJ, Arsh A, Shah J, Islam SMS. Insufficient Physical Activity and Sedentary Behaviors among Medical Students during the COVID-19 Lockdown: Findings from a Cross-Sectional Study in Pakistan. Int J Environ Res Public Health. 2021 Sep 29;18(19):10257. doi: 10.3390/ijerph181910257. PMID 34639559

Идентификаторы

NCT: NCT06561126 · KMU/DIR/CTU/2024/007 · NIHR203248

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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