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NCT06386692 Clinical Trial

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

Exercise Clinical Trial

Official title:
Community-based Promotion of Physical Activity in a Semi-urban Area of Pokhara Metropolitan City, Nepal: a Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06386692
Other study ID # Aarhus111
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date December 30, 2024

Study information
Verified date March 2024
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 264
Est. completion date December 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• FCHVs-led community based educational physical activity intervention
This intervention will be designed to promote physical activity among adults

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary Mean moderate to vigorous physical activity Change in mean moderate-to-vigorous physical activity per day 6 months
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