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

S

St. John's Research Institute

Status

Unknown

Conditions

Cardiovascular Disease

Treatments

Behavioral: Educational Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02388542
PROGRESS-IND-1022015

Details and patient eligibility

About

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).

Full 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.

Enrollment

334 patients

Sex

All

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

334 participants in 1 patient group

lifestyle counseling
Experimental group
Description:
we will have a trained peer mentor educating employees regarding lifestyle modification for control of cardiovascular disease risk factors and following them up for a duration of 3 months
Treatment:
Behavioral: Educational Intervention

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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