Hypertension Clinical Trial
Official title:
Acceptability, Feasibility and Effectiveness of a Worksite Intervention to Lower Cardiometabolic Risk in South Africa
As an important way to translate cardiovascular disease prevention efforts, worksite interventions can facilitate healthy food choices, health education, and social support. This proposed project is adapted and scaled-up from the Nepal study, and will measure the effectiveness of a canteen and a behavioral intervention on cardio-metabolic risk at a worksite in South Africa. This study will estimate the added benefit of a proven individual-level dietary intervention over environmental-level changes for preventing cardio-metabolic risk within the South African context. If the study demonstrates a significant effect, a scaled-up approach could produce an important reduction in cardiovascular disease burden through environmental and individual level prevention programs in South Africa.
Status | Not yet recruiting |
Enrollment | 350 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Full time employees - 18 years or above of age - No confirmation of diabetes and, not on diabetes medication OR Have HbA1c of 5.7% to 6.4%. OR Prediabetes group with FBS of 100- 126 mg/dL Systolic blood pressure 120 mm Hg or more or Diastolic blood pressure 80 mm Hg or more and not on blood pressure medication Exclusion Criteria: - Less than 18 years - On diabetes medication - On hypertension medication |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Durban University of Technology | Dhulikhel Hospital, Yale University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiometabolic Risks | A composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease =0.5%; a systolic blood pressure decrease (SBP) =5 mm Hg; and plasma triglycerides decrease =10 mg/d | six months | |
Primary | Healthy food intake | Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data | Six months | |
Secondary | Hba1c | Glycated haemoglobin, % continuous variable | Six months | |
Secondary | Systolic Blood pressure | An average of three measurements, mmHg continuous variabl | Six months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |