ExerciseNCT06386692
Community Based Promotion of Physical Activity in Nepal (COBIN-PA)
A study testing FCHVs-led community based educational physical activity intervention in people with Exercise, run by University of Aarhus at 1 site in Nepal.
Trial summary
Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- FCHVs-led community based educational physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 69 years
- without the intention of migrating out of the area for the next 6 months
Who cannot join
- Those severely ill
- History of mental illness
- Decline to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-based Promotion of Physical Activity in a Semi-urban Area of Pokhara Metropolitan City, Nepal: a Cluster-randomized Controlled Trial
Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity.
- Conditions
- Exercise
- Being tested
- FCHVs-led community based educational physical activity intervention
- Keywords
- Physical activity, Non-communicable disease, Nepal
- Medical subject headings
- Motor Activity, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCHVs-led community based educational physical activity interventionBehavioural
This intervention will be designed to promote physical activity among adults
| Study group | Role | What they receive |
|---|---|---|
| PA promotion intervention | Experimental | Behavioral: FCHV visit
- FCHVs will provide family based physical activity educational intervention through household visit in selected households monthly for 3 months. Receives: Behavioral: FCHVs-led community based educational physical activity intervention |
| Wait-list control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean moderate to vigorous physical activity
Change in mean moderate-to-vigorous physical activity per day
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Sep 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386692
- Sponsor's protocol ID
- Aarhus111
- Status last verified
- Nov 2024
- First submitted
- 23 Apr 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shrestha R, Paudel S, Rijal A, Adhikari TB, Gradidge PJ, Khatri B, Neupane D, Skejo SD, Vaidya A, Sanders T, Lonsdale C, Subedi N, Koirala S, Kallestrup P, Nielsen RO. Effectiveness of a female community health volunteer-led physical activity education intervention on accelerometer-derived outcomes in semi-urban Nepal: an open-label, cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2026 Feb 23;23(1):34. doi: 10.1186/s12966-026-01894-0.
PubMed 41731554Shrestha R, Adhikari TB, Khatri B, Neupane D, Paudel S, Nielsen RO, Skejo SD, Vaidya A, Kallestrup P. Community-based promotion of physical activity in Nepal: study protocol for a cluster-randomized controlled trial. Trials. 2025 May 24;26(1):170. doi: 10.1186/s13063-025-08885-9.
PubMed 40413519
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Promotion of Physical Activity in a Semi-urban Area of Pokhara Metropolitan City, Nepal: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06386692
- Acronym / sponsor ID
- Aarhus111
- Conditions
- Exercise
- Keywords
- Physical activity, Non-communicable disease, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA promotion intervention | Experimental | Behavioral: FCHVs-led community based educational physical activity interventionBehavioral: FCHV visit - FCHVs will provide family based physical activity educational intervention through household visit in selected households monthly for 3 months. |
| Wait-list control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 69 years
- without the intention of migrating out of the area for the next 6 months
Key exclusion criteria (3 listed)
- Those severely ill
- History of mental illness
- Decline to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCHVs-led community based educational physical activity interventionThis intervention will be designed to promote physical activity among adults | Behavioural | PA promotion intervention |
Primary outcome
Mean moderate to vigorous physical activity
Time frame: 6 months
Change in mean moderate-to-vigorous physical activity per day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41731554Shrestha R, Paudel S, Rijal A, Adhikari TB, Gradidge PJ, Khatri B, Neupane D, Skejo SD, Vaidya A, Sanders T, Lonsdale C, Subedi N, Koirala S, Kallestrup P, Nielsen RO. Effectiveness of a female community health volunteer-led physical activity education intervention on accelerometer-derived outcomes in semi-urban Nepal: an open-label, cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2026 Feb 23;23(1):34. doi: 10.1186/s12966-026-01894-0.
- Derived from this study: PubMed 40413519Shrestha R, Adhikari TB, Khatri B, Neupane D, Paudel S, Nielsen RO, Skejo SD, Vaidya A, Kallestrup P. Community-based promotion of physical activity in Nepal: study protocol for a cluster-randomized controlled trial. Trials. 2025 May 24;26(1):170. doi: 10.1186/s13063-025-08885-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCHVs-led community based educational physical activity intervention in people with Exercise, run by University of Aarhus at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean moderate to vigorous physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386692, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.