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

Not Applicable

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Educational Intervention

• Registration Number: NCT02388542
• Lead Sponsor: St. John's Research Institute

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.

Study Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-17
• Study Start: 2015-05
• Status Verified: 2016-10
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 334

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lifestyle counseling	Educational Intervention	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

Primary Outcome Measures

Name	Time	Method
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)	3 Months	validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)	1 Month	A 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 Months	qualitative analysis - In depth interviews and focus groups discussions with random sample of participants

Trial Locations

Locations (6)

Sri Lanka Telecom; 🇱🇰 Colombo, Sri Lanka

Appollo Ispat Complex Ltd; 🇧🇩 Dhaka, Bangladesh

TVS Motor company Limited; 🇮🇳 Hosur, India

Department of Census & Statistics; 🇱🇰 Colombo, Sri Lanka

Shardharan Bima Coorporation; 🇧🇩 Dhaka, Bangladesh

Bharat Heavy Electrical Limited; 🇮🇳 Bangalore, India