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Clinical Trials/NCT06386692
NCT06386692
Completed
Not Applicable

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

University of Aarhus1 site in 1 country264 target enrollmentSeptember 1, 2024
ConditionsExercise

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise
Sponsor
University of Aarhus
Enrollment
264
Locations
1
Primary Endpoint
Mean moderate to vigorous physical activity
Status
Completed
Last Updated
5 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
April 10, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean moderate to vigorous physical activity

Time Frame: 6 months

Change in mean moderate-to-vigorous physical activity per day

Study Sites (1)

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