Community Based Promotion of Physical Activity in Nepal (COBIN-PA)

NCT ID: NCT06386692

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PA promotion intervention

Behavioral: FCHV visit

\- FCHVs will provide family based physical activity educational intervention through household visit in selected households monthly for 3 months.

Group Type EXPERIMENTAL

FCHVs-led community based educational physical activity intervention

Intervention Type BEHAVIORAL

This intervention will be designed to promote physical activity among adults

Wait-list control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FCHVs-led community based educational physical activity intervention

This intervention will be designed to promote physical activity among adults

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 69 years
* without the intention of migrating out of the area for the next 6 months

Exclusion Criteria

* Those severely ill
* History of mental illness
* Decline to provide consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nepal Development Society

Pokhara, Gandaki, Nepal

Site Status

Countries

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Nepal

References

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Shrestha 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.

Reference Type DERIVED
PMID: 40413519 (View on PubMed)

Other Identifiers

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Aarhus111

Identifier Type: -

Identifier Source: org_study_id

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