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Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites

Policy and Peer Mentor Intervention Programs on Cardiovascular Disease at Small to Medium Sized Worksites in 3 South Asian Countries - a Pilot Study for a Definitive Large International Cluster Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02388542
Acronym
PROGRESS
Enrollment
334
Registered
2015-03-17
Start date
2015-05-31
Completion date
2017-12-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

cardiovascular disease, education, peer mentor

Brief summary

The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).

Detailed description

Eligibility Criteria - All employees aged above 35 years at selected workplaces. Study design - Mixed methods methods Phase 1 - Qualitative study; Phase 2 - Quantitative - Single group, non-randomized before-after comparison study + KAP survey Sample size - Approximately 334 participants. The study entails the following steps - Step 1 - An evaluation for knowledge, attitudes and practices (KAP) related to cardiovascular health/ disease at worksites. Step 2 - A qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health Step 3 - Baseline assessment of cardiovascular risk using a non-lab based risk assessment score Step 4 - Piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.

Interventions

BEHAVIORALEducational Intervention

Employees above the age of 35 years will be risk stratified into moderate or high risk of developing cardiovascular disease using a simple non-lab based risk scoring system, they will be invited to participate in the pilot intervention study. This is a single arm before-after study.subject education will focus on life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
University of Colombo
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
St. John's Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* All criteria must be met to be eligible 1. Employees (Men & Women) above the age of 35 years. 2. permanent employees with at least 6 months for retirement. 3. Willing to provide Informed Consent.

Exclusion criteria

* Subject ineligible if even one criterion is met 1. Pregnant or intent to get pregnant in one year. 2. Inability to attend follow up visits. 3. Any active malignancy or known malignancy on treatment. 4. Will relocate during the study period. 5. Unwilling or unable to comply with study procedures.

Design outcomes

Primary

MeasureTime frameDescription
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)1 MonthA knowledge, attitudes & practices questionnaire will be administered to participants
Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)3 Monthsqualitative analysis - In depth interviews and focus groups discussions with random sample of participants
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)3 Monthsvalidated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score

Countries

Bangladesh, India, Sri Lanka

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026