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Идёт набор NCT07350694

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

Без фазы С лечением Diabetes Type 2 Type II Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PLA.
Кому может быть актуально
Состояния в реестре: Diabetes Type 2, Type II Diabetes Mellitus. Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Afghanistan
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D-Afg]: Feasibility Trial in Rural Kabul-Afghanistan

Обзор

This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.

Подробное описание

This approach centres on adapting, implementing, and evaluating a Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II Diabetes. Mellitus (TIIDM). TIIDM is one of the fastest-growing health emergencies globally, affecting an estimated 589 million adults, with projections for 2050 indicating a 45% increase in diabetes. Approximately 80% of people with TIIDM live in low- and middle-income countries (LMICs), placing further strain on already overburdened health systems.

Afghanistan shows similarly concerning trends, with an age-standardised diabetes prevalence of 11.7%, affecting 1.93 million adults in 2024 and projected to rise to 4.76 million by 2050, with 71.4% remaining undiagnosed. Prevalence rises sharply with age and varies by province for example, approximately 11% in Kabul, 11.8% in Nangarhar, and over 22% in Kandahar. These figures highlight the urgency of developing culturally appropriate and evidence-based interventions to prevent and control diabetes in Afghan communities.

The intervention draws on evidence from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic)" trial, which proved effective in rural Bangladesh. However, PLA-based interventions have yet to be tested in rural Afghan communities. Recognizing the distinct sociocultural context, geopolitical and health system challenges in rural Kabul, Afghanistan, a feasibility trial will be carried out in selected rural sites of Kabul Province.

This feasibility trial will evaluate the adaptability and implementation of the intervention within Afghanistan's context. By applying evidence-based practices and fostering meaningful community participation through PLA, the initiative aims to improve social and behavioural determinants of health, enhance diabetes prevention and control, and create a model for addressing other non-communicable diseases in Afghan communities.

Вмешательства

  • Поведенческое PLA
    An PLA based intervention would be carried out to prepare the individuals with TIIDM. The intervention would be carried out for a tentative time of 2 to 3 hours to educate the community. The study participants would be evaluated after completion of 10 months of the intervention. A structured, validated and literature-based end line assessment checklist will be devised to assess the feasibility of the intervention.

Первичные конечные точки

  • To culturally adapt PLA-based intervention (D-Magic) for primary prevention and control of TIIDM in rural communities of Afghanistan [Срок оценки: 10 months]
  • To test the feasibility of the culturally adapted PLA-based intervention (D-Magic) [Срок оценки: 12 months]
  • To test the acceptability of the culturally adapted PLA-based intervention (D-Magic) [Срок оценки: 12 months]
Вторичные конечные точки (4)
  • To estimate the inter-correlation coefficient to inform future adjustment of sample size [Срок оценки: 6 months]
  • To identify and examine potential Barriers to Implementation of the PLA-Based Intervention [Срок оценки: 12 months]
  • To identify and examine potential facilitators of Implementation of the PLA-Based Intervention [Срок оценки: 12 months]
  • To assess the frequency of Type 2 Diabetes and Intermediate Hyperglycaemia [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • For intervention phase: Individuals aged 20 years and above. For baseline and endline assessments (before and after the intervention): Individuals aged 30 years and above.
  • Participants residing in the randomized clusters of Kabul, Afghanistan Individuals willing to participate in the study and provide consent.
  • All individuals with normoglycemia, intermediate hyperglycaemia, and diabetes are encouraged to participate.
  • Participants who can attend the scheduled meetings and interventions as per the study protocol.

Критерии исключения

  • For Intervention phase: Individuals below the age of 20 years. For baseline and endline assessments (before and after the intervention): individuals below the age of 30 years.
  • Individuals unwilling to provide consent for participation.
  • Participants with reported health conditions that may hinder their active involvement in the study.
  • Individuals with non-compliance with 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

Afghanistan · 1 центр
  • HealthNet TPO, Afghanistan — Kabul

Идентификаторы

NCT: NCT07350694 · HealthNet TPO, A-12-24-464 · NIHR 203248

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗