Non-Physician Health Worker Support for Metabolic Syndrome

(SIP Trial)

Overseen By Dipika Desai, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonia Anand

Disqualifiers: Coronary artery disease, Stroke, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with metabolic syndrome, a condition involving high blood sugar, high blood pressure, and unhealthy cholesterol levels, by providing support from trained non-physician health workers. These health workers will guide participants in adopting healthy lifestyle habits and maintaining contact with their family doctors. The trial includes online and in-person visits over 12 months to enhance participants’ health. It suits those who have been informed of their cardiovascular risk and struggle with managing high blood pressure, cholesterol, or blood sugar levels. As an unphased trial, it offers a unique opportunity for personalized support and potential improvement in health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this protocol is safe?

Research has shown that health workers who aren't doctors, such as nurses and pharmacists, can safely help people manage their health. These workers assist individuals in making healthier lifestyle choices. Studies have found that these programs are well-received. Participants often experience health improvements, such as weight loss and better management of diabetes and heart disease risks. The studies have reported no major safety issues, indicating that this support is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing metabolic syndrome by utilizing non-physician health workers (NPHWs). Unlike standard treatments that primarily rely on direct physician visits, this method employs trained allied health professionals, like pharmacists and nurses, to support patients in adhering to lifestyle changes and coordinating care. This approach could potentially make healthcare more accessible and personalized, enhancing patient engagement and adherence to treatment plans. By involving NPHWs, the trial aims to bridge gaps in care and provide continuous support, which could lead to better health outcomes for patients with metabolic syndrome.

What evidence suggests that Non-Physician Health Worker support is effective for metabolic syndrome?

Research has shown that involving trained health workers who are not doctors can help manage high blood pressure and diabetes, especially in low-income areas. In this trial, participants in the implementation group will receive support from non-physician health workers (NPHWs) to assist in reducing obesity and overweight issues by encouraging healthier lifestyle choices. This support can lead to better management of heart and metabolic conditions. Evidence suggests that extra help from trained health professionals can significantly improve health. ^{6 7 8 9 10}

Who Is on the Research Team?

Lita Cameron, MD, MSc

Principal Investigator

McMaster University

Sonia Anand, MD, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals already part of the SCORE! Cohort study with issues like high blood sugar, bad cholesterol levels, and high blood pressure. They should be at risk for heart disease but don't need to have a medical background. The key is they haven't been excluded from the main SCORE! study.

Inclusion Criteria

Participants will be identified from the SCORE! Cohort study who have previously received a letter indicating their cardiovascular risk score

Uncontrolled CV risk factors defined as: Blood pressure measurements: systolic ≥ 140 or diastolic BP ≥ 90 mm Hg; Non-HDL cholesterol > 2.66 mmol/L; Random plasma glucose of ≥ 11.1 mmol/L or HbA1c% ≥ 6.5%

Exclusion Criteria

Involvement in another study or program that would interfere with the study protocol

Pregnancy or plans to become pregnant within 12 months

Other serious conditions or logistic factors likely to interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guidance from Non-Physician Health Workers (NPHW) to improve cardiovascular health through lifestyle changes and medical referrals

12 months

Online and on-site visits

Follow-up

Participants are monitored for changes in cardiovascular risk factors and adherence to recommendations

12 months

5 follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Non-Physician Health Worker

Trial Overview The trial tests if health workers without a medical degree can help improve participants' health over 12 months. These workers are trained in health sciences and work under a doctor's supervision, using online and on-site visits to manage conditions like diabetes and high cholesterol.

How Is the Trial Designed?

Group I: Implementation group. Experimental Treatment 1 Intervention

The study is based on the HOPE-4 protocol, where trained individuals will support participants in adhering to healthy lifestyle recommendations and support their access to a family physician to follow up on care recommendations. The NPHWs will be allied health professionals (e.g., pharmacists, internationally trained physicians, physiotherapists, nurses). The team will train them on study goals, responsibilities, data management, and follow-up, based on the HOPE-4 training manual. Training will be given once at the beginning of their role and then once annually. The NPHW will support the participant, if needed, in contacting the family doctor and assisting to arrange a follow-up study. If required, the family doctor can contact the NPHW. If further discussion is required or there are questions regarding the study that require further discussion, the NPHW will contact the study physician to address these issues.

Who Is Running the Clinical Trial?

Sonia Anand

Lead Sponsor

Trials

1

Recruited

140+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

The My Health Matters! program successfully engaged 43% of employees in health risk assessments and identified metabolic syndrome risk factors in over half of those who attended clinical visits, leading to a significant 15% reduction in risk factors over six months.

The program was well-received, with 82% of participants recommending it to other employers, demonstrating its feasibility and value as a workplace intervention for managing metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). Tarride, JE., Harrington, K., Balfour, R., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2219825/

Effectiveness of a Lifestyle Intervention on Metabolic ... A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities.

2. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(19)30077-4/fulltext

Task sharing with non-physician health-care workers for ... Our meta-analysis shows that task-sharing interventions are effective in reducing average blood pressure in low-income and lower-middle income ...

3. npjournal.org npjournal.org/article/S1555-4155(25)00186-2/fulltext

Improving Health Outcomes Through Nurse Practitioner– ... The current literature continues to support the use of lifestyle medicine in the treatment of obesity and cardiometabolic-related diseases.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8279953/

Task-sharing interventions for improving control of diabetes ... Task sharing interventions with non-physician healthcare workers show moderate effectiveness in diabetes management in LMIC settings.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0311507

The effect of results-based motivating system on metabolic risk ... Involving non-physician health workers and having action plans based on the health needs of the covered population can decrease obesity and overweight in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039584/

and Middle‐Income Countries: A Realist Review We included all studies published until 12 January 2023, reporting the effects of workplace lifestyle education interventions on metabolic syndrome. Using a ...

7. mdpi.com mdpi.com/2072-6643/13/12/4560

Effectiveness of Workplace-Based Diet and Lifestyle ... We carried out a systematic review, meta-analysis and meta-regression of articles measuring the association between workplace dietary interventions and MetS ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4351781/

Improving Employee Health: Evaluation of a Worksite ... Most importantly, regardless of when they started the intervention, both groups demonstrated significant weight loss and improvements in diabetes and CVD risk ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/30/NCT05005130/Prot_SAP_000.pdf

Mixed methods formative research and pilot testing of a ... SmartCare to include an NCD module and automatic decision-support prompts for non-physician health workers. We envision that this may ...

10. archpublichealth.biomedcentral.com archpublichealth.biomedcentral.com/articles/10.1186/s13690-023-01047-w

Motivating non-physician health workers to reduce the ... This study evaluated the effectiveness of interventions that aimed at increasing non-physician community health workers' motivation in reducing ...