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.

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.

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.

ClinicalTrial.gov NCT06386692. Registered on 26 April 2024.

Ethical Review Board, Nepal Health Research Council, Protocol number 726/2023, approved on 8th February 2024.

Globally, insufficient physical activity(PA) has risen to epidemic levels in the past few decades [1]. One in four adults does not meet the World Health Organization (WHO) recommended 150 min of moderate intensity or 75 min of vigorous intensity PA per week [2]. About 33% of Southeast Asians have insufficient PA, and the population-attributable risk for all-cause mortality is 8.5% [3]. It is the fourth leading risk, contributing to 9% of global premature mortality with the increased prevalence of non-communicable diseases (NCDs) [4]. PA is regarded as one of the most effective strategies for NCD prevention and management, improving cardiorespiratory fitness, quality of life, and overall well-being and lowering the risk of all-cause mortality [5,6,7,8,9,10,11,12,13].

The WHO attributes 66% of all deaths in Nepal to NCDs [14, 15]. The burden of insufficient PA is as high as 44.1% [16,17,18,19,20]. Even though only 7% of people are insufficiently active in national data, a high proportion (43.1%) of people living in semi-urban areas are insufficiently active, with less leisure time PA and high sedentary behavior, despite the benefits of moderate to vigorous PA (MVPA) [13, 17,18,19, 21]. The actual extent of insufficient PA could be much higher due to potential under-reporting in the subjective assessment utilized in those surveys [22, 23].

Nepal has set a target of achieving a 10% relative reduction in insufficient PA by 2025. However, a country guideline is not yet developed [24, 25]. Lack of knowledge and motivation are identified as major barriers to PA in Nepal, which may be effectively addressed through community-based educational interventions [26,27,28]. PA intention, which predicts actual physical activity, increases by 9% through educational interventions in semi-urban area of Nepal [26, 27, 29]. Moreover, actual physical activity levels are significantly increased (p= 0.01) through these educational interventions [30]. Community-based PA intervention by trained volunteers is a cost-effective and culturally appropriate approach to reduce insufficient PA and its health consequences [31,32,33]. Female Community Health Volunteers (FCHVs) are existing grassroots-level human resources in Nepal, providing effective community-based services in reproductive, neonatal, and child health [34]. Their engagement in the detection and community-based management of diabetes, hypertension, cervical cancer, and chronic obstructive pulmonary disease (COPD) has also been found effective [35,36,37]. Involving FCHVs for PA promotion could be a practical approach, due to their community reach, trust, and cultural understanding, and could make the intervention more inclusive and cost-effective. However, it needs to be tested. Hence, we propose to engage FCHVs for community-based PA promotion and evaluate its effectiveness.

The aim of this cluster randomized controlled trial is to assess the effectiveness of FCHV-led community-based PA promotion among adults in a semi-urban setting in Nepal. We hypothesize that there will be a significant increase in MVPA minutes per day among the intervention group.

A community-based, open-label, two-group cluster randomized controlled trial with 1:1 allocation to the intervention and wait-list control arms will be conducted over a 6-month duration, including baseline and follow-up assessments in a semi-urban area of Pokhara Metropolitan City (previously Lekhnath Municipality) in Gandaki Province, Nepal. The municipality has a population of 64,118 in 24,883 households, an 88.1% literacy rate, a life expectancy of 59.7 years, and a sex ratio of 84 males per 100 females [38]. There are 133 FCHVs providing services in the study area. This study extends the pre-existing Community-based Management of Non-communicable Disease in Nepal (COBIN) study, ongoing since 2014 in collaboration with the Research Unit for Global Health at the Department of Public Health, Aarhus University [35].

Eligible individuals aged 18–69 years residing in the study area will be the participants for this study. People listed in the voter list of 2022 as residents of the study area, aged 18 to 69 years old, and without the intention of migrating out of the area for the next six months, will be included. The participants who are bedridden will be excluded from the study.

We will first conduct a baseline survey in all 15 clusters (geographical areas—the sub-municipal areas (called wards)—of the municipality). Systematic random sampling technique will be applied to select the households from all 15 clusters using a COBIN sampling frame [35]. KISH method will be applied to further select a participant from eligible family members [39].

Recruitment for the trial will be done among the participants of the baseline study. Two-stage sampling techniques will be used to recruit the participants for the trial.

First stage

Among 15 clusters, an independent statistician will randomly exclude one ward through the lottery method. From the remaining 14 clusters, 7 each will be randomly allocated to either the intervention or control arm through computer-generated random numbers by an independent statistician.

Second stage

Participants in the intervention and wait-list arms will be selected randomly from participants in the baseline survey from clusters allocated in respective arms, through computer generated random numbers by an independent statistician. The selected cluster and participants will not be shared with anyone by the statistician until the interventions are assigned. PI will enroll participants and assign participants to the interventions. The planned flow of participants for the trial is illustrated in Fig. 1 below.

Planned flow of participants through the trial

Full size image

We will conduct focus group discussions with end users to understand their perspectives on PA, including their experiences, barriers, and facilitators. The intervention will be developed based on findings of FGD and situation analysis (baseline) survey through a user experience-based co-design approach, involving separate workshops with end users and a panel of experts. A panel including public health researchers, physiotherapists, health workers, and local citizens, will develop a community-based PA promotional package, guided by the Theory of Planned Behaviour (TPB), a behavior-understanding theory in which attitude, subjective norms, and perceived behavioral control all influence behavioral intention and, ultimately, determine behavior or action, which is found most effective in increasing PA [40,41,42,43,44]. The intervention materials development process will be based on the P-process, a tool for planning strategic, evidence-based health communication programs that have been used to design strategic health communication programs worldwide [45].

The intervention consists of several key components. Firstly, a 3-day intensive training program will be provided to FCHVs, covering NCDs and their risk factors, the health consequences of insufficient PA, the benefits of regular PA, and strategies for engaging community members in physical activity. The training will use interactive workshops, role-playing, and practical sessions to equip FCHVs with the necessary skills and knowledge. During the first three months, FCHVs will conduct monthly family-based interactive health education sessions through home visits. These sessions will involve interactive discussions on the importance of PA, demonstrations of simple exercises that can be performed at home, and the distribution and explanation of educational materials such as booklets and manuals. These sessions aim to educate, motivate, and support families in incorporating PA into their daily routines, so that the intervention will be simple to understand and improve adherence.

The intervention will be discontinued to the participants if they migrate to another place or decline to continue the research participation. If the study results indicate that the intervention is effective, it will also be provided to the wait-list control group. We will also do process evaluation and report it, including details of intervention development in a separate paper.

Only outcome assessor will be blinded in this study. Data analyst will not be blinded in this study.

Sample size for situation analysis survey (baseline)

Using the methods suggested in the WHO STEPwise approach to NCD risk factor surveillance (STEPS) survey [18], taking prevalence of insufficient PA (p) = 0.101 [18], margin of error 0.05, alpha 0.05, sex estimates of 2 (2 sex groups), 1.5 design effect and adding expected nonresponse rate 20%, the calculated sample size for the baseline survey is 523.

Taking the reference of community-based trials on PA [46, 47], estimated increase in PA of 8.2 MVPA minutes/day, assuming a standard deviation of 18, using a two-sided t test with a significance level of 0.05, 80% power; considering 0.01 intra-cluster correlation, design effect of 1.39 [48], needs 106 individuals per arm. Adjusting a 20% non-response rate, the final sample size will be 132 individuals per arm, and 264 individuals in total that will be recruited from participants of baseline survey.

Trained enumerators with an undergraduate degree in Public Health and previous experience in conducting community-based surveys will collect data through household surveys. The Principal Investigator and a public health expert having community-based survey experience will provide training to enumerators through a four-day training session. Face-to-face interviews will be done using a structured questionnaire. Enumerators will measure height, weight, waist circumference, and blood pressure and perform a 1-min sit-to-stand test following a specific measurement protocol developed for this study, following the measurement procedure used in the STEPS survey Nepal 2019. Participants will be given an wrist-worn Axivity AX3 accelerometer for a week to measure PA objectively.

The tool for this study will be adopted from a validated Nepali version of WHO STEPs survey for non-communicable disease risk factors containing sociodemographic variables, anthropometric variables (height, weight and waist circumference), and blood pressure, including the Nepali version of the General Physical Activity Questionnaire for subjective measurement of PA [18]. Nepali versions of WHO Quality of Life Brief Version questionnaire, Depression Anxiety and Stress Scale (DASS-21), and Pittsburgh Sleep Quality Index (PSQI) will be used to assess quality of life, mental health status, and sleep quality, respectively [49,50,51]. Attitude, intention, and enabling factors for PA will be assessed using a questionnaire adapted from the Nepali version of the Theory of Planned Behaviour-based teacher-targeted PA intervention study in a similar setting [26].

Objective assessment of physical activity

This study will use wrist-worn accelerometers (AX3, Axivity Ltd. UK) to measure PA objectively, sedentary behavior, and sleeping patterns among participants. Axivity AX3 is a triaxial accelerometer that has been used in large-scale epidemiological studies like the UK and China Biobank studies [52, 53]. The device will be set to record seven days’ acceleration at 100 Hz with a dynamic range of ± 8 g. Enumerators will distribute the accelerometer to the participants at the end of the interview during data collection. Enumerators will explain about the accelerometer and instruct the participants to wear the wristband on the non-dominant wrist for seven consecutive days for 24 h, including sleeping time during the baseline and follow-up surveys. Enumerators will collect the accelerometer on 9 th day after distribution. Data will be omitted for individuals who have worn the device for fewer than three days or lack wear data for each 1-h interval within the 24-h cycle [52]. AX3-GUI, OmGui software (https://github.com/digitalinteraction/openmovement/wiki/AX3-GUI) will be used to set up the device and download raw data from the accelerometer. We will compute the Euclidean Norm Minus One (ENMO) metric from the raw accelerations and calculate MVPA minutes per day [53,54,55].

All data, except for accelerometer data, will be collected and stored in the RedCap application. The data collection instruments will be designed with data validation rules to prevent data entry errors and missing variables. Daily checks will be conducted on the collected data to identify and address any inconsistencies. The raw data will be transferred from RedCap to a computer in CSV format. Accelerometer data will be retrieved using OmGUI software and saved in CWA format. Raw data will be stored in three locations: an online drive, an internal hard drive, and an external hard drive. The accelerometer data files will be named using the format XXXXX_00YYYYMMDD, where “XXXXX” represents the device serial number and “YYYYMMDD” indicates the start date of the measurement. This naming convention will help link the participant to their acceleration data.

Quantitative analysis will be done using the RStudio (2024 Posit Software, PBC formerly RStudio, PBC) and/or R (2023, The R Foundation for Statistical Computing). We will follow the principle of intention-to-treat while doing data analysis and do imputation to address missing data. In the beginning, this study will compare the baseline characteristics of the participants in both arms. A mixed-effect linear regression model will determine the adjusted interaction between time and intervention on change in MVPA minutes per day. Correlation and Bland–Altman analysis will be performed to see the correlation and agreement between subjective and objective measures of PA. A two-sided p-value will be reported at a 95% confidence interval, and less than 0.05 will be considered significant. We will also do subgroup analysis.

The study’s primary outcome is the change in objectively measured mean MVPA minutes per day due to time intervention interaction. The secondary outcomes of the study are the change in PA intention, cardiometabolic health indicators, health-related quality of life, and quality of sleep from baseline to follow-up in the intervention group compared to the wait-list control group. Follow-up survey will be done at 6 th months post randomization. We will also report our experience regarding the practicality of objective measurements of PA in the Nepalese context.

The Principal Investigator (PI) will supervise the whole study process. All enumerators, intervention providers, and field supervisors will get intensive training to ensure data quality. Field supervisors will do regular monitoring of data collection and intervention implementation. Field supervisors, PI, and FCHVs will meet every month to review the progress. Data collection will be done using the RedCap application, which provides checks to minimize data entry errors. The PI will check data daily to ensure data quality. Data recollection will be done if any deviation in the data quality is found. Data will be saved in an online drive, computer, and external hard drive to avoid possible data loss.

Cluster randomization used in this study will reduce the possibility of contamination as the selected clusters will be geographically separated. FCHVs will be instructed not to share any information with the people of other clusters other than the intervention group.

The study carries minimal to no risk to the participants, so the study will not provide any compensation or insurance plan. FCHVs will be provided with US$5 per home visit as travel compensation.

The findings of this study will be shared in a dissemination program, meetings organized locally, and through workshops, conferences, and peer-reviewed article publications.

This study could be the first of its kind to assess the effectiveness of community-based PA promotion led by FCHVs in Nepal on objectively measured mean change in MVPA minutes per day. Given the rising burden of NCDs in Nepal, promoting PA through community engagement is crucial. This study uses objective measures to capture PA levels, which enhances the reliability of the findings. We will use a cluster randomized controlled trial and do cluster randomization rather than true randomization to avoid the contamination of our education intervention as clusters are geographically separated. However, the cRCT design introduces specific challenges, such as the potential for within-cluster correlations that could reduce statistical power. To address this, the study will employ mixed-effects models or generalized estimating equations in its analysis. Additionally, variability in FCHV engagement and community characteristics may affect the intervention’s effectiveness, while the lack of blinding could introduce biases. These issues will be mitigated by blinding outcome assessors and using rigorous statistical methods.

FCHVs are part of Nepal’s health system and serve as the foundation of a community-based health program in Nepal. They have received basic healthcare training and are dedicated to raising awareness of health-related issues and promoting health in their respective communities. Likewise, FCHVs are the largest available health human resource deeply rooted in the community. So, developing low-cost, locally available, resource-based, culturally acceptable, and easily deliverable PA promotion initiatives for FCHVs could be beneficial in promoting PA and ultimately reducing the burden of NCDs in Nepal. Community-based PA promotion by trained volunteers is also an inexpensive approach for potentially reducing insufficient PA and its health consequences [30, 48]. If the intervention is found effective, it could be beneficial to scale up and integrate into the National level FCHVs program and package of essential non-communicable disease interventions (PEN) implemented in Nepal.

The strength of this study is the objective assessment of PA using an accelerometer. We will report the process, feasibility, and challenges regarding the objective measurement of PA at the community level in the Nepalese context. As subjective measurement is believed to overestimate PA, successful implementation of objective measurement could provide an example for adoption of objective measurement in future studies in and for studies done in other similar countries.

This study has some limitations worth mentioning. Participants may be enthusiastic about adopting the physical activity at the beginning, and this study may not be able to explain its long-term sustainability and need long-term follow-up. Previous trials done in the same cohort also have a PA component. However, these trials were done many years ago without follow-up and may have minimal to no effect on our outcome. Using accelerometers can pose challenges, such as device malfunctions or participant non-compliance. Strategies to mitigate these issues include maintaining a sufficient number of spare devices to replace any that malfunction, providing clear instructions to participants, conducting regular check-ins to ensure proper use, and opting for wrist-mounted devices instead of hip or thigh-mounted ones, as wristbands are more culturally acceptable in the Nepalese context.

This is the second version of the trial modified on 2024–05–06. We started recruiting the first participant from 1 August 2024, and the date of recruitment completion was 15 August 2024. The schedule for enrollment, intervention, and assessment is shown in Fig. 2 as the SPIRIT Fig [56]. Intervention development and implementation were completed, and the anticipated date of follow-up survey completion is 15 April 2025. In case any amendment is required in the trial protocol, it will be communicated to the Ethical Review Board, Nepal Health Research Council, and ClinicalTrials.gov.

Schedule of enrollment, intervention, and assessments (SPIRIT figure)

Full size image

WHO:

World Health Organization

PA:

Physical activity

FCHVs:

Female Community Health Volunteers

GPAQ:

Global Physical Activity Questionnaire

NCDs:

Non-communicable diseases

MVPA:

Moderate to vigorous physical activity

COBIN:

Community-based management of non-communicable diseases in Nepal

TPB:

Theory of Planned Behaviour

DASS:

Depression Anxiety and Stress Scale

PSQI:

Pittsburgh Sleep Quality Index

ENMO:

Euclidean Norm Minus One

PI:

Principal Investigator

PEN:

Package of Essential Non-communicable Diseases interventions

Download references

RS, PK, TBA, BK, AV, SP, SDS, and DN conceptualized, designed, and contributed to the critical revision of the study. RS is the principal investigator of this study. RS drafted and critically revised the manuscript. BK, AV, SP, and RON contributed to successive drafts of the manuscript. All authors read and approved the final manuscript.

Correspondence to Rajan Shrestha.

The protocol was approved by the Ethical Review Board of Nepal Health Research Council (726-2023). Participation will be voluntary, and informed written consent will be obtained from participants and FCHVs. All data will be kept safe and confidential. Approval from metropolitan city will be taken.

The authors declare no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.

Reprints and permissions