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

NCT06386692 | Completed DMC

• 1 other identifier: Aarhus111
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise

Keywords

Physical activity; Non-communicable disease; Nepal

Outcome Measures

Primary Outcomes (1)

• Mean moderate to vigorous physical activity

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

  6 months

Study Arms (2)

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.

Behavioral: FCHVs-led community based educational physical activity intervention

Wait-list control

NO INTERVENTION

No intervention

Interventions

FCHVs-led community based educational physical activity intervention BEHAVIORAL

This intervention will be designed to promote physical activity among adults

PA promotion intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Those severely ill
• History of mental illness
• Decline to provide consent

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Nepal Development Society

Pokhara, Gandaki, 33700, Nepal

Location

Related Publications (1)

• 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.

  PMID: 40413519 DERIVED

MeSH Terms

Conditions

Motor Activity; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: September 1, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)