NCT04494139

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

July 28, 2020

Last Update Submit

July 30, 2020

Conditions

Dietary InterventionPre DiabetesHypertension

Keywords

Pre diabetesCanteen interventionBehavioral intervention

Outcome Measures

Primary Outcomes (2)

  • 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

  • Healthy food intake

    Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data

    Six months

Secondary Outcomes (2)

  • Hba1c

    Six months

  • Systolic Blood pressure

    Six months

Study Arms (2)

Canteen Only

ACTIVE COMPARATOR

Train canteen staff and implement canteen intervention in the canteen space: interventions targeting food quality and quantity, intervention targeting food choice at point of sale, interventions target improved supply, interventions targeting price and promotional material.

Other: Canteen

Behavioral and Canteen intervention

EXPERIMENTAL

The behavioral intervention will be comprised of a combination of intensive education sessions and goal setting and monitoring based on a validated worksite curriculum tailored to local needs. The curriculum includes 24 sessions: 16 core weekly sessions during the first four months of the intervention followed by 8 weekly maintenance sessions (text messages). Each session will be facilitated by a nutritionist/dietitian and a peer educator; and will last one hour. Broadly, the curriculum covers the subject matters of importance of healthy weight, eating a healthy diet, increasing physical activity, stress management, and challenges of lifestyle changes. Participants will be encouraged to keep food and activity diaries throughout the course of the study. During the maintenance period, the focus will be on overcoming declines in motivation and on maintaining long-term healthy behaviors.

Behavioral: Behavioral and Canteen interventionOther: Canteen

Interventions

Behavioral and Canteen interventionBEHAVIORAL

Behavioral intervention: 16 weeks

Behavioral and Canteen intervention
CanteenOTHER

Canteen changes to introduce health foods

Behavioral and Canteen interventionCanteen Only

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full time employees
  • 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

You may not qualify if:

  • Less than 18 years
  • On diabetes medication
  • On hypertension medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose IntoleranceHypertension

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ashika Naicker, PhD

    Durban University of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashika Naicker, PhD

CONTACT

3732333ashikan@dut.ac.za

Evonne Singh, MEd

CONTACT

3732311evonnes@dut.ac.za

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Arm 1: Canteen only intervention Arm 2: Canteen and behavioral intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share