<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494139</url>
  </required_header>
  <id_info>
    <org_study_id>IREC173/18</org_study_id>
    <nct_id>NCT04494139</nct_id>
  </id_info>
  <brief_title>Acceptability, Feasibility and Effectiveness of a Worksite Intervention to Lower Cardiometabolic Risk in South Africa</brief_title>
  <official_title>Acceptability, Feasibility and Effectiveness of a Worksite Intervention to Lower Cardiometabolic Risk in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Durban University of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dhulikhel Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Durban University of Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As an important way to translate cardiovascular disease prevention efforts, worksite&#xD;
      interventions can facilitate healthy food choices, health education, and social support. This&#xD;
      proposed project is adapted and scaled-up from the Nepal study, and will measure the&#xD;
      effectiveness of a canteen and a behavioral intervention on cardio-metabolic risk at a&#xD;
      worksite in South Africa. This study will estimate the added benefit of a proven&#xD;
      individual-level dietary intervention over environmental-level changes for preventing&#xD;
      cardio-metabolic risk within the South African context. If the study demonstrates a&#xD;
      significant effect, a scaled-up approach could produce an important reduction in&#xD;
      cardiovascular disease burden through environmental and individual level prevention programs&#xD;
      in South Africa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of the multi-component environmental worksite intervention will be measured&#xD;
      by evaluating the change in number of individuals attaining two or more cardiometabolic risk&#xD;
      reduction goals (i.e., reductions in HbA1c, blood pressure, triglycerides, cholesterol and&#xD;
      weight). Secondary outcomes will include the individual changes in the risk factors included&#xD;
      in the primary outcome, as well as in cardiometabolic risk not included in the composite&#xD;
      score (i.e., LDL, HDL, total cholesterol/HLD ratio), in dietary intake, in physical activity,&#xD;
      and in worksite-level food and beverage sales.&#xD;
&#xD;
      Specific objectives is as follows:&#xD;
&#xD;
        1. To measure the effectiveness of a canteen intervention on a composite score based upon&#xD;
           improvement in cardio-metabolic risk factors (0-3) with success defined by HbA1c&#xD;
           decrease ≥0.5%; a systolic blood pressure decrease ≥5 mmHg; and a decrease in plasma&#xD;
           triglycerides ≥10 mg/dl. We will compare the change in the score after six months of the&#xD;
           canteen intervention to the baseline results.&#xD;
&#xD;
        2. To measure the effectiveness of a behavioral intervention on a composite score based&#xD;
           upon improvement in cardio-metabolic risk factors (0-3) with success defined by HbA1c&#xD;
           decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg. We will compare the change&#xD;
           in the score in behavior intervention group to the baseline results.&#xD;
&#xD;
        3. To measure the effectiveness of a canteen intervention on diabetes risk (By comparing&#xD;
           the change in HbA1c of participants after six months of canteen intervention to the&#xD;
           baseline results).&#xD;
&#xD;
        4. To measure the effectiveness of a behavioral intervention on diabetes risk (By comparing&#xD;
           the change in HbA1c of participants after six months of behavior plus canteen&#xD;
           intervention to the change over six months during the canteen only intervention).&#xD;
&#xD;
        5. To measure the combined effect of canteen and behavioral intervention on diabetes risk&#xD;
           (By comparing the change in HbA1c levels of the participants of canteen plus behavioral&#xD;
           intervention to baseline results).&#xD;
&#xD;
        6. To measure the effectiveness of a canteen intervention on dietary behavior (By comparing&#xD;
           change in the proportion of healthy foods adopted by the participants after six months&#xD;
           of canteen intervention to the change in the proportion of healthy food consumption at&#xD;
           baseline).&#xD;
&#xD;
        7. To measure the effectiveness of a behavioral intervention on dietary behavior (By&#xD;
           comparing the change in the proportion of healthy foods eaten by the participants after&#xD;
           six months of behavior plus canteen intervention to the change over six months during&#xD;
           the canteen only intervention) Interventions The study will recruit 350 employees at a&#xD;
           worksite in Durban, Kwa Zulu Natal using the worksite characteristic checklist for best&#xD;
           fit to the study. Formative work will be done to determine the best fit for the&#xD;
           implementation of the intervention to the worksite. At baseline, 6 months, 12 months and&#xD;
           18 months, standard questionnaire will be administered to record relevant&#xD;
           characteristics of the participants, physical activity, smoking, stress, alcohol intake&#xD;
           and diet. Food sales data will be abstracted from the administrative database of the&#xD;
           canteen. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and&#xD;
           lipid profile (HDL, LDL, total cholesterol, triglycerides). Participants height, weight,&#xD;
           waist circumference, hip circumference, and blood pressure will be measured. After 6&#xD;
           months of control period, the participants will receive the canteen intervention. After&#xD;
           six months of the canteen/physical environment intervention, half of the participants&#xD;
           will be randomized to receive a canteen and behavioral intervention; whereas the other&#xD;
           half receives canteen only intervention. The behavioral intervention will be comprised&#xD;
           of a combination of intensive education sessions and goal setting and monitoring based&#xD;
           on a validated worksite curriculum tailored to local needs. The curriculum will include&#xD;
           24 sessions: 16 core weekly sessions during the first four months of the intervention&#xD;
           followed by 8 weekly maintenance sessions (text messages). Each session will be&#xD;
           facilitated by a nutritionist/dietitian and a peer educator; and will last one hour.&#xD;
           Broadly, the curriculum will cover the subject matters of importance of healthy weight,&#xD;
           eating a healthy diet, increasing physical activity, stress management, and challenges&#xD;
           of lifestyle changes. Participants will be encouraged to keep food and activity diaries&#xD;
           throughout the course of the study. During the maintenance period, the focus will be on&#xD;
           overcoming declines in motivation and on maintaining long-term healthy behaviors.&#xD;
           Participants will set at least two lifestyle change goals such as consuming half of the&#xD;
           total grains as whole grains, walking 30 minutes a day, reducing 7% of the body weight,&#xD;
           and similar goals to achieve during the sessions based on their baseline CVD profile.&#xD;
           Participants will be followed up at 6 months (at the end of step 1 intervention), 12&#xD;
           months (at the end of step 2 intervention). During each follow up, fasting blood samples&#xD;
           will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL,&#xD;
           total cholesterol, triglycerides).&#xD;
&#xD;
      The primary analysis will use chi squared test use to compare (a) Proportion of individual&#xD;
      with score ≥ 2 during canteen only intervention to the proportion of individual with score ≥&#xD;
      2 during the control period; (b) Proportion of individual with score ≥ 2 during canteen and&#xD;
      behavioral intervention to the proportion of individual with score ≥ 2 during canteen only&#xD;
      intervention. Logistic regression for the proportion of individual with score ≥ 2 as outcome&#xD;
      and canteen only vs canteen and behavioural as exposure will be conducted. Secondary analysis&#xD;
      will use paired t-test to compare (a) the change in healthy food intake and HbA1c during&#xD;
      canteen only intervention to the change in healthy food intake and HbA1C during the control&#xD;
      period (b) the change in healthy food intake and HbA1C% during canteen and behavioral&#xD;
      intervention to the change in healthy food intake and HbA1C% during canteen only&#xD;
      intervention.&#xD;
&#xD;
      The following process outcomes will be measured:&#xD;
&#xD;
        1. Program adoption will be measured by quantifying workers participation through&#xD;
           calculating the percentages of total employees agreeing to screening, and percentages&#xD;
           agreeing to participate in the intervention.&#xD;
&#xD;
        2. Program fidelity will be determined by measuring changes in the worksite environment,&#xD;
           and management support for the program. To assess compliance to the recommended dietary&#xD;
           interventions (i.e., provide healthy food options in the canteen, eliminate SSBs) every&#xD;
           month in the intervention period, a member of the study team not affiliated with the&#xD;
           worksite will do a random audit.&#xD;
&#xD;
        3. Program feasibility will be measured by quantifying the changes in sales of healthy and&#xD;
           unhealthy foods and beverages at the canteen from baseline to follow-up.&#xD;
&#xD;
        4. Program adoption and acceptability will be assessed through focus group discussions with&#xD;
           employees (lifestyle participants and lifestyle drop outs) managers and non-eligible&#xD;
           participants on worksite environmental changes.&#xD;
&#xD;
        5. The value and return on investment of the intervention for employers will be measured by&#xD;
           assessing program cost and cost-effectiveness and changes in staff productivity,&#xD;
           absenteeism, health status, and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Arm 1: Canteen only intervention Arm 2: Canteen and behavioral intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiometabolic Risks</measure>
    <time_frame>six months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthy food intake</measure>
    <time_frame>Six months</time_frame>
    <description>Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hba1c</measure>
    <time_frame>Six months</time_frame>
    <description>Glycated haemoglobin, % continuous variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood pressure</measure>
    <time_frame>Six months</time_frame>
    <description>An average of three measurements, mmHg continuous variabl</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Dietary Intervention</condition>
  <condition>Pre Diabetes</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Canteen Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral and Canteen intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral and Canteen intervention</intervention_name>
    <description>Behavioral intervention: 16 weeks</description>
    <arm_group_label>Behavioral and Canteen intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Canteen</intervention_name>
    <description>Canteen changes to introduce health foods</description>
    <arm_group_label>Behavioral and Canteen intervention</arm_group_label>
    <arm_group_label>Canteen Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full time employees&#xD;
&#xD;
          -  18 years or above of age&#xD;
&#xD;
          -  No confirmation of diabetes and, not on diabetes medication OR Have HbA1c of 5.7% to&#xD;
             6.4%. OR Prediabetes group with FBS of 100- 126 mg/dL Systolic blood pressure 120 mm&#xD;
             Hg or more or Diastolic blood pressure 80 mm Hg or more and not on blood pressure&#xD;
             medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years&#xD;
&#xD;
          -  On diabetes medication&#xD;
&#xD;
          -  On hypertension medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashika Naicker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durban University of Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashika Naicker, PhD</last_name>
    <phone>3732333</phone>
    <phone_ext>031</phone_ext>
    <email>ashikan@dut.ac.za</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evonne Singh, MEd</last_name>
    <phone>3732311</phone>
    <phone_ext>031</phone_ext>
    <email>evonnes@dut.ac.za</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Durban University of Technology</investigator_affiliation>
    <investigator_full_name>Dr Ashika Naicker</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Pre diabetes</keyword>
  <keyword>Canteen intervention</keyword>
  <keyword>Behavioral intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494139
org study id: IREC173/18
nct id: NCT04494139
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1: Canteen only intervention Arm 2: Canteen and behavioral intervention
primary purpose: Prevention
masking: None (Open Label)
measure: Cardiometabolic Risks
time frame: six months
description: 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
measure: Healthy food intake
time frame: Six months
description: Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data
measure: Hba1c
time frame: Six months
description: Glycated haemoglobin, % continuous variable
measure: Systolic Blood pressure
time frame: Six months
description: An average of three measurements, mmHg continuous variabl
arm group label: Canteen Only
arm group type: Active Comparator
description: 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.
arm group label: Behavioral and Canteen intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Behavioral and Canteen intervention
description: Behavioral intervention: 16 weeks
arm group label: Behavioral and Canteen intervention
intervention type: Other
intervention name: Canteen
description: Canteen changes to introduce health foods
arm group label: Behavioral and Canteen intervention
arm group label: Canteen Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ashika Naicker, PhD
role: Principal Investigator
affiliation: Durban University of Technology
last name: Ashika Naicker, PhD
phone: 3732333
phone ext: 031
email: ashikan@dut.ac.za
last name: Evonne Singh, MEd
phone: 3732311
phone ext: 031
email: evonnes@dut.ac.za
responsible party type: Principal Investigator
investigator affiliation: Durban University of Technology
investigator full name: Dr Ashika Naicker
investigator title: Senior Lecturer
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No