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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Since the newly developed intervention will be a behavioral intervention it is impossible to mask the participants, care provider and the investigator'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Quasi experimental study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of physical activity', 'timeFrame': 'Baseline, three and six months', 'description': 'Physical activity will be categorized in 3 categories as low, moderate and high physical activity levels. Who is achieving minimum total physical activity of at least 600 MET-minutes/week -3000 MET min/ week will be categorized as moderate physical activity level. Those who achieve total physical activity level of more than 3000 MET min/week will be categorized as high physical activity, Those who do not meet those criteria will be considered as low physical activity.'}, {'measure': 'Exercise self-efficacy', 'timeFrame': 'baseline, three and six months', 'description': "Culturally validated locally adopted Bandura's Exercise Self-Efficacy Scale (18 item) will be used. Lower score indicated lesser self efficacy and higher score indicates higher self-efficacy."}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline, three and six months', 'description': 'Systolic and Diastolic blood pressure, sphygmomanometer will be used to assess the blood pressure in "mmHg".'}, {'measure': 'Knowledge', 'timeFrame': 'Baseline,3 months and 6 months', 'description': 'Knowledge on Physical activity, Interviewer administered questionnaire is developed to assess knowledge, Pre defined score will be given to the responses. Pre-defined cut off value will be used (based on exert opinion) to categorize them in to "good" and "poor" knowledge categories.'}, {'measure': 'Attitude', 'timeFrame': 'Baseline and three, six months', 'description': 'Attitude on physical activity, attitude on physical activity, Interviewer administered questionnaire is developed to assess attitude, Pre defined score will be given to the responses. Pre-defined cut off value will be used (based on exert opinion) to categorize them into "favorable" and "unfavorable" attitude categories.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'primary care', 'behavioural intervention', 'level of physical activity improvement'], 'conditions': ['Physical Activities', 'Cardiovascular (CV) Risk', 'Empowerment']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors?\n\n* What changes occur in physical activity level, BMI and blood pressure following participation in the intervention?\n* Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period?\n* 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.\n\nParticipants will:\n\n* Participate in the INSPIRE-PA program for 6 months\n* 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\n* Engage in structured physical activity as recommended in the intervention package\n* Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary\n* Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments', 'detailedDescription': "Development of intervention package\n\nBased 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.\n\nThe 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.\n\n* 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.\n* 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.\n* 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.\n* 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.\n\nTopics, Mode of delivery and intended constructs in new intervention package Session /Topic /Mode of delivery\n\nTopic 1 :\n\n1.1NCDs, Behavioral risk factors and intermediate risk factors of Chronic NCDs 1.2 Consequences following physical inactivity\n\nMode of delivery:\n\nInteractive sessions PowerPoint presentation Educational pamphlets\n\nTopic 2:\n\n2.1Benefits of physical activity, Barriers \\& Solutions\n\nMode of delivery:\n\nInteractive learning/discussion sessions PowerPoint presentation Educational pamphlets and leaflets\n\nTopic 3:\n\n3.1Physical 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\n\nMode of delivery:\n\nPosters Practical training Videos PowerPoint presentation\n\nTopic 4:\n\n4.1Improvement of self-efficacy in physical activities\n\nMode of delivery:\n\nGroup discussion -Practical training\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients permanently residing in Gampaha district for six months or more\n2. Patients registered and followed up at medical clinics in the same state sector PMCIs in Gampaha district, for a duration of three months or more\n\nExclusion Criteria:\n\n1. Pregnant mothers with any intermediate risk factor of chronic NCDs, followed up at state PMCIs in Gampaha district\n2. Patients diagnosed with atherosclerotic cardiovascular disease (ASCVD) (e.g. Coronary heart disease, Cerebrovascular disease, Peripheral artery disease, Aortic atherosclerotic disease) followed up at state sector primary medical care institutions in Gampaha district.\n3. Patients already diagnosed and on treatment for diabetes mellitus, any type of cancer and any chronic respiratory disease (e.g. Asthma, chronic obstructive pulmonary disease) followed up at state sector primary medical care institutions in Gampaha district, as their physical activity level and their knowledge on it may have changed following the diagnosis\n4. Patients with impaired cognitive functions (confirmed with medical records), as they are unable to report accurate responses independently.\n5. Patients who have undergone any surgical procedure within the last three months (confirmed by clinical documentation)\n6. Patients who have had any debilitating illness during the preceding week limiting their physical activity during the period of illness\n7. Patients who plan to change/change their place of residence or shift their treatment follow-up from a state-sector PMCI to the private sector or any other treatment modality (e.g: Ayurveda) within the next six months'}, 'identificationModule': {'nctId': 'NCT07440056', 'acronym': 'INSPIRE-PA', 'briefTitle': 'Physical Inactivity Among Patients With Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of Colombo'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ERC/PGIM/2025/268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'INSPIRE-PA intervention study arm', 'interventionNames': ['Behavioral: INSPIRE-PA intervention study arm']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Usual care control arm'}], 'interventions': [{'name': 'INSPIRE-PA intervention study arm', 'type': 'BEHAVIORAL', 'description': 'newly developed package will be derived to them', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Gampaha', 'state': 'Western Province', 'country': 'Sri Lanka', 'contacts': [{'name': 'Regional Director of Health Services, Gampaha District, MBBS, MSc, MD', 'role': 'CONTACT', 'email': 'rdhsgampaha@gmail.com', 'phone': '0332222874'}, {'name': 'Provincial Director of Health Services, MBBS, MD', 'role': 'CONTACT', 'email': 'info@healthdept.wp.gov.lk', 'phone': '0112434660'}, {'name': 'Dulshani Gunawardhana, MBBS, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Primary Medical Care Institutes in Gampaha district', 'geoPoint': {'lat': 7.0897, 'lon': 79.9925}}], 'centralContacts': [{'name': 'Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine)', 'role': 'CONTACT', 'email': 'gunawardhana.dulshani1@gmail.com', 'phone': '+94707490191'}, {'name': 'Dulshani P. Gunawardhana, MBBS,MSc', 'role': 'CONTACT', 'email': 'gunawardhana.dulshani1@gmail.com', 'phone': '+94707490191'}], 'overallOfficials': [{'name': 'Dulshani Gunawardhana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGIM, University of Colombo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colombo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registrar in Community Medicine', 'investigatorFullName': 'Dulshani Pujitha Gunawardhana', 'investigatorAffiliation': 'University of Colombo'}}}}