Rajan Shrestha, Tara Ballav Adhikari, Bijay Khatri, Dinesh Neupane, Susan Paudel, Rasmus Østergaard Nielsen, Sebastian Deisting Skejø, Abhinav Vaidya, Per Kallestrup
{"title":"尼泊尔以社区为基础促进身体活动：一项集群随机对照试验的研究方案。","authors":"Rajan Shrestha, Tara Ballav Adhikari, Bijay Khatri, Dinesh Neupane, Susan Paudel, Rasmus Østergaard Nielsen, Sebastian Deisting Skejø, Abhinav Vaidya, Per Kallestrup","doi":"10.1186/s13063-025-08885-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Globally, one in four adults does not meet the WHO-recommended at least 150 min of moderate intensity physical activity per week. Insufficient physical activity is the fourth-leading risk factor, contributing to 9% of global premature mortality. Physical activity is effective in weight management, cardiorespiratory fitness, and enhancing the quality of life. A high proportion (43.1%) of people living in semi-urban areas of Nepal have insufficient physical activity. Limited evidence shows a lack of knowledge and motivation as major barriers to physical activity in Nepal. Female Community Health Volunteers (FCHVs) in Nepal are effectively contributing to community-based maternal, neonatal, child, and reproductive health and the detection and management of non-communicable diseases. They could potentially contribute to physical activity promotion in community settings.</p><p><strong>Methods and design: </strong>The study aims to evaluate the effectiveness of a FCHV-led community-based intervention on change in daily moderate to vigorous physical activity (MVPA) minutes. We plan to conduct an open-label cluster-randomized controlled trial with 1:1 allocation in semi-urban areas of Pokhara Municipality, Nepal. In this trial, we will recruit 264 adults 18-69 years from 14 included clusters. Axivity AX3 accelerometer and the Global Physical Activity Questionnaire (GPAQ) will be used to measure physical activity before and after the six-month intervention. FCHVs will deliver community-based educational intervention through household visits for three months, to motivate participants for physical activity through interactive health education sessions. The primary outcome is the mean change in MVPA minutes per day. Secondary outcomes include changes in physical activity intention, health-related quality of life, stress, anxiety, depression, cardiometabolic health indicators, and sleep quality.</p><p><strong>Discussion: </strong>This study will objectively explore physical activity among adults in a Nepali community and provide evidence on the effectiveness of a FCHV-led community-based intervention on physical activity promotion in Nepal.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov NCT06386692. Registered on 26 April 2024.</p><p><strong>Trial registration in nepal: </strong>Ethical Review Board, Nepal Health Research Council, Protocol number 726/2023, approved on 8th February 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"170"},"PeriodicalIF":2.0000,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102969/pdf/","citationCount":"0","resultStr":"{\"title\":\"Community-based promotion of physical activity in Nepal: study protocol for a cluster-randomized controlled trial.\",\"authors\":\"Rajan Shrestha, Tara Ballav Adhikari, Bijay Khatri, Dinesh Neupane, Susan Paudel, Rasmus Østergaard Nielsen, Sebastian Deisting Skejø, Abhinav Vaidya, Per Kallestrup\",\"doi\":\"10.1186/s13063-025-08885-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Globally, one in four adults does not meet the WHO-recommended at least 150 min of moderate intensity physical activity per week. Insufficient physical activity is the fourth-leading risk factor, contributing to 9% of global premature mortality. Physical activity is effective in weight management, cardiorespiratory fitness, and enhancing the quality of life. A high proportion (43.1%) of people living in semi-urban areas of Nepal have insufficient physical activity. Limited evidence shows a lack of knowledge and motivation as major barriers to physical activity in Nepal. Female Community Health Volunteers (FCHVs) in Nepal are effectively contributing to community-based maternal, neonatal, child, and reproductive health and the detection and management of non-communicable diseases. They could potentially contribute to physical activity promotion in community settings.</p><p><strong>Methods and design: </strong>The study aims to evaluate the effectiveness of a FCHV-led community-based intervention on change in daily moderate to vigorous physical activity (MVPA) minutes. 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Community-based promotion of physical activity in Nepal: study protocol for a cluster-randomized controlled trial.
Background: Globally, one in four adults does not meet the WHO-recommended at least 150 min of moderate intensity physical activity per week. Insufficient physical activity is the fourth-leading risk factor, contributing to 9% of global premature mortality. Physical activity is effective in weight management, cardiorespiratory fitness, and enhancing the quality of life. A high proportion (43.1%) of people living in semi-urban areas of Nepal have insufficient physical activity. Limited evidence shows a lack of knowledge and motivation as major barriers to physical activity in Nepal. Female Community Health Volunteers (FCHVs) in Nepal are effectively contributing to community-based maternal, neonatal, child, and reproductive health and the detection and management of non-communicable diseases. They could potentially contribute to physical activity promotion in community settings.
Methods and design: The study aims to evaluate the effectiveness of a FCHV-led community-based intervention on change in daily moderate to vigorous physical activity (MVPA) minutes. We plan to conduct an open-label cluster-randomized controlled trial with 1:1 allocation in semi-urban areas of Pokhara Municipality, Nepal. In this trial, we will recruit 264 adults 18-69 years from 14 included clusters. Axivity AX3 accelerometer and the Global Physical Activity Questionnaire (GPAQ) will be used to measure physical activity before and after the six-month intervention. FCHVs will deliver community-based educational intervention through household visits for three months, to motivate participants for physical activity through interactive health education sessions. The primary outcome is the mean change in MVPA minutes per day. Secondary outcomes include changes in physical activity intention, health-related quality of life, stress, anxiety, depression, cardiometabolic health indicators, and sleep quality.
Discussion: This study will objectively explore physical activity among adults in a Nepali community and provide evidence on the effectiveness of a FCHV-led community-based intervention on physical activity promotion in Nepal.
Trial registration: ClinicalTrial.gov NCT06386692. Registered on 26 April 2024.
Trial registration in nepal: Ethical Review Board, Nepal Health Research Council, Protocol number 726/2023, approved on 8th February 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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