- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06386692
Community Based Promotion of Physical Activity in Nepal (COBIN-PA)
April 23, 2024 updated by: University of Aarhus
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
264
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 19 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
No intervention
|
|
Experimental: Intervention Group
Behavioral: FCHV visit - FCHVs will provide family based physical activity educational intervention through household visit in selected households monthly for 3 months. |
This intervention will be designed to promote physical activity among adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean moderate to vigorous physical activity
Time Frame: 6 months
|
Change in mean moderate-to-vigorous physical activity per day
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
April 23, 2024
First Submitted That Met QC Criteria
April 23, 2024
First Posted (Actual)
April 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Aarhus111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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