Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:29 PM
Study NCT ID:
NCT07440056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Inactivity Among Patients With Cardiovascular Risk
Sponsor:
University of Colombo
Organization:
Study Overview
Official Title:
Physical Inactivity Among Patients With Cardiovascular Risk: Proportion, Associated Factors, Perceived Barriers, and Effectiveness of an Intervention for Improvement at Government Primary Medical Care Institutions in Gampaha District
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE-PA
Brief Summary:
The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are:
Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors?
* What changes occur in physical activity level, BMI and blood pressure following participation in the intervention?
* Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period?
* Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions.
Participants will:
* Participate in the INSPIRE-PA program for 6 months
* Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators
* Engage in structured physical activity as recommended in the intervention package
* Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary
* Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments
Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors?
* What changes occur in physical activity level, BMI and blood pressure following participation in the intervention?
* Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period?
* Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions.
Participants will:
* Participate in the INSPIRE-PA program for 6 months
* Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators
* Engage in structured physical activity as recommended in the intervention package
* Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary
* Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments
Detailed Description:
Development of intervention package
Based on the identified literature evidence and identified behavioural change theory, an intervention model will be developed by the principal investigator and consensus will be obtained from the expert panel \[consisted of Consultant Community Physicians, Consultant in Sports Medicine, Consultant Family physician, Two Medical officer In charge (one from DH and one from PMCU) and Public Health Nursing Officer\] using the modified delphi technique and seeking opinions from a few, purposively selected patients with intermediate risk factors for chronic NCDs from Kalutara district. The framework of the intervention will be finalized along with the content of the intervention.
The recommended evidence-based behavioral change techniques can be adopted to design an effective program to achieve physical activity promotion, which consists of different key components. These components can be basically described as replicable, observable and irreducible components of the intervention designed to modify physical activity behavior. These active elements will be used to promote physical activity behavior change of an individual . Following behavioral change techniques will be considered in developing the intervention package.
* Set goals and plans Realistic goals will be set to achieve the expected and recommended physical activity behavior in individuals. The goals will be aligned with the concept of SMART (Specific, Measurable, Attainable, Realistic and Time bound). The goals will be tailor made to everyone. Promoting small activities and graded goal setting will be considered. This will promote individual's small achievements without experiencing failures with unrealistic goals.
* Enhance knowledge Practical knowledge and skills on physical activity will be increased by enhancing awareness on physical activity and self-efficacy levels, that will be delivered in sessions. These sessions will consist of both educational and practical components.
* Social support Advice and practical help from their family members, caregivers, peers and healthcare staff to individuals to support achieving their expected behavior change goals.
* Monitoring and evaluation of behavioral outcomes Monitoring and evaluating behavioral outcomes are essential for assessing participants' adoption and maintenance of regular physical activity following an intervention. This process includes systematic tracking of both short-term and long-term changes in activity levels with validated instruments such as the international physical activity questionnaire (IPAQ). Additionally, it examines modifications in associated factors such as motivation, self-efficacy, and perceived barriers. By analyzing pre- and post-intervention data, the evaluation determines whether there have been improvements in both physical activity and health-related beliefs. Continuous monitoring and feedback facilitate iterative adjustments to optimize participant adherence and maintain the intervention's effectiveness and relevance. Overall, the evaluation of behavioral outcomes provides critical insights into the intervention's capacity to support sustained, healthy lifestyle change. Future intervention development will be informed by constructs from the health belief model. The topics for each interactive session, delivery mode, and targeted construct are detailed as follows.
Topics, Mode of delivery and intended constructs in new intervention package Session /Topic /Mode of delivery
Topic 1 :
1.1NCDs, Behavioral risk factors and intermediate risk factors of Chronic NCDs 1.2 Consequences following physical inactivity
Mode of delivery:
Interactive sessions PowerPoint presentation Educational pamphlets
Topic 2:
2.1Benefits of physical activity, Barriers \& Solutions
Mode of delivery:
Interactive learning/discussion sessions PowerPoint presentation Educational pamphlets and leaflets
Topic 3:
3.1Physical activity pyramid, level and types (based on F.I.T.T.E principle; Frequency, Intensity, Time, Type, Enjoyment) 3.2Regular \& correct physical activity 3.3 Role of friends, family in the continuation of physical activity \& doing walking
Mode of delivery:
Posters Practical training Videos PowerPoint presentation
Topic 4:
4.1Improvement of self-efficacy in physical activities
Mode of delivery:
Group discussion -Practical training
The newly developed intervention package will be delivered to a randomly selected intervention group and will be compared with a control group receiving usual care. A quasi-experimental study design will be employed to evaluate the effectiveness of the newly developed intervention package.
Based on the identified literature evidence and identified behavioural change theory, an intervention model will be developed by the principal investigator and consensus will be obtained from the expert panel \[consisted of Consultant Community Physicians, Consultant in Sports Medicine, Consultant Family physician, Two Medical officer In charge (one from DH and one from PMCU) and Public Health Nursing Officer\] using the modified delphi technique and seeking opinions from a few, purposively selected patients with intermediate risk factors for chronic NCDs from Kalutara district. The framework of the intervention will be finalized along with the content of the intervention.
The recommended evidence-based behavioral change techniques can be adopted to design an effective program to achieve physical activity promotion, which consists of different key components. These components can be basically described as replicable, observable and irreducible components of the intervention designed to modify physical activity behavior. These active elements will be used to promote physical activity behavior change of an individual . Following behavioral change techniques will be considered in developing the intervention package.
* Set goals and plans Realistic goals will be set to achieve the expected and recommended physical activity behavior in individuals. The goals will be aligned with the concept of SMART (Specific, Measurable, Attainable, Realistic and Time bound). The goals will be tailor made to everyone. Promoting small activities and graded goal setting will be considered. This will promote individual's small achievements without experiencing failures with unrealistic goals.
* Enhance knowledge Practical knowledge and skills on physical activity will be increased by enhancing awareness on physical activity and self-efficacy levels, that will be delivered in sessions. These sessions will consist of both educational and practical components.
* Social support Advice and practical help from their family members, caregivers, peers and healthcare staff to individuals to support achieving their expected behavior change goals.
* Monitoring and evaluation of behavioral outcomes Monitoring and evaluating behavioral outcomes are essential for assessing participants' adoption and maintenance of regular physical activity following an intervention. This process includes systematic tracking of both short-term and long-term changes in activity levels with validated instruments such as the international physical activity questionnaire (IPAQ). Additionally, it examines modifications in associated factors such as motivation, self-efficacy, and perceived barriers. By analyzing pre- and post-intervention data, the evaluation determines whether there have been improvements in both physical activity and health-related beliefs. Continuous monitoring and feedback facilitate iterative adjustments to optimize participant adherence and maintain the intervention's effectiveness and relevance. Overall, the evaluation of behavioral outcomes provides critical insights into the intervention's capacity to support sustained, healthy lifestyle change. Future intervention development will be informed by constructs from the health belief model. The topics for each interactive session, delivery mode, and targeted construct are detailed as follows.
Topics, Mode of delivery and intended constructs in new intervention package Session /Topic /Mode of delivery
Topic 1 :
1.1NCDs, Behavioral risk factors and intermediate risk factors of Chronic NCDs 1.2 Consequences following physical inactivity
Mode of delivery:
Interactive sessions PowerPoint presentation Educational pamphlets
Topic 2:
2.1Benefits of physical activity, Barriers \& Solutions
Mode of delivery:
Interactive learning/discussion sessions PowerPoint presentation Educational pamphlets and leaflets
Topic 3:
3.1Physical activity pyramid, level and types (based on F.I.T.T.E principle; Frequency, Intensity, Time, Type, Enjoyment) 3.2Regular \& correct physical activity 3.3 Role of friends, family in the continuation of physical activity \& doing walking
Mode of delivery:
Posters Practical training Videos PowerPoint presentation
Topic 4:
4.1Improvement of self-efficacy in physical activities
Mode of delivery:
Group discussion -Practical training
The newly developed intervention package will be delivered to a randomly selected intervention group and will be compared with a control group receiving usual care. A quasi-experimental study design will be employed to evaluate the effectiveness of the newly developed intervention package.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: