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.
The effectiveness of the multi-component environmental worksite intervention will be measured
by evaluating the change in number of individuals attaining two or more cardiometabolic risk
reduction goals (i.e., reductions in HbA1c, blood pressure, triglycerides, cholesterol and
weight). Secondary outcomes will include the individual changes in the risk factors included
in the primary outcome, as well as in cardiometabolic risk not included in the composite
score (i.e., LDL, HDL, total cholesterol/HLD ratio), in dietary intake, in physical activity,
and in worksite-level food and beverage sales.
Specific objectives is as follows:
1. To measure the effectiveness of a canteen intervention on a composite score based upon
improvement in cardio-metabolic risk factors (0-3) with success defined by HbA1c
decrease ≥0.5%; a systolic blood pressure decrease ≥5 mmHg; and a decrease in plasma
triglycerides ≥10 mg/dl. We will compare the change in the score after six months of the
canteen intervention to the baseline results.
2. To measure the effectiveness of a behavioral intervention on a composite score based
upon improvement in cardio-metabolic risk factors (0-3) with success defined by HbA1c
decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg. We will compare the change
in the score in behavior intervention group to the baseline results.
3. To measure the effectiveness of a canteen intervention on diabetes risk (By comparing
the change in HbA1c of participants after six months of canteen intervention to the
baseline results).
4. To measure the effectiveness of a behavioral intervention on diabetes risk (By comparing
the change in HbA1c of participants after six months of behavior plus canteen
intervention to the change over six months during the canteen only intervention).
5. To measure the combined effect of canteen and behavioral intervention on diabetes risk
(By comparing the change in HbA1c levels of the participants of canteen plus behavioral
intervention to baseline results).
6. To measure the effectiveness of a canteen intervention on dietary behavior (By comparing
change in the proportion of healthy foods adopted by the participants after six months
of canteen intervention to the change in the proportion of healthy food consumption at
baseline).
7. To measure the effectiveness of a behavioral intervention on dietary behavior (By
comparing the change in the proportion of healthy foods eaten by the participants after
six months of behavior plus canteen intervention to the change over six months during
the canteen only intervention) Interventions The study will recruit 350 employees at a
worksite in Durban, Kwa Zulu Natal using the worksite characteristic checklist for best
fit to the study. Formative work will be done to determine the best fit for the
implementation of the intervention to the worksite. At baseline, 6 months, 12 months and
18 months, standard questionnaire will be administered to record relevant
characteristics of the participants, physical activity, smoking, stress, alcohol intake
and diet. Food sales data will be abstracted from the administrative database of the
canteen. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and
lipid profile (HDL, LDL, total cholesterol, triglycerides). Participants height, weight,
waist circumference, hip circumference, and blood pressure will be measured. After 6
months of control period, the participants will receive the canteen intervention. After
six months of the canteen/physical environment intervention, half of the participants
will be randomized to receive a canteen and behavioral intervention; whereas the other
half receives canteen only intervention. 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 will include
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 will cover 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.
Participants will set at least two lifestyle change goals such as consuming half of the
total grains as whole grains, walking 30 minutes a day, reducing 7% of the body weight,
and similar goals to achieve during the sessions based on their baseline CVD profile.
Participants will be followed up at 6 months (at the end of step 1 intervention), 12
months (at the end of step 2 intervention). During each follow up, fasting blood samples
will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL,
total cholesterol, triglycerides).
The primary analysis will use chi squared test use to compare (a) Proportion of individual
with score ≥ 2 during canteen only intervention to the proportion of individual with score ≥
2 during the control period; (b) Proportion of individual with score ≥ 2 during canteen and
behavioral intervention to the proportion of individual with score ≥ 2 during canteen only
intervention. Logistic regression for the proportion of individual with score ≥ 2 as outcome
and canteen only vs canteen and behavioural as exposure will be conducted. Secondary analysis
will use paired t-test to compare (a) the change in healthy food intake and HbA1c during
canteen only intervention to the change in healthy food intake and HbA1C during the control
period (b) the change in healthy food intake and HbA1C% during canteen and behavioral
intervention to the change in healthy food intake and HbA1C% during canteen only
intervention.
The following process outcomes will be measured:
1. Program adoption will be measured by quantifying workers participation through
calculating the percentages of total employees agreeing to screening, and percentages
agreeing to participate in the intervention.
2. Program fidelity will be determined by measuring changes in the worksite environment,
and management support for the program. To assess compliance to the recommended dietary
interventions (i.e., provide healthy food options in the canteen, eliminate SSBs) every
month in the intervention period, a member of the study team not affiliated with the
worksite will do a random audit.
3. Program feasibility will be measured by quantifying the changes in sales of healthy and
unhealthy foods and beverages at the canteen from baseline to follow-up.
4. Program adoption and acceptability will be assessed through focus group discussions with
employees (lifestyle participants and lifestyle drop outs) managers and non-eligible
participants on worksite environmental changes.
5. The value and return on investment of the intervention for employers will be measured by
assessing program cost and cost-effectiveness and changes in staff productivity,
absenteeism, health status, and quality of life.
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