Feasibility Study to Increase Vegetable Consumption
Condition: Increase Intake of Vegetables or Tomatoes; Health
Study type: Interventional

Summary: 
      The objective of this study is to determine if differences exist in the total vegetable
      intake of groups that eat either tomato products versus raw vegetable product.
    

Detailed description: 
      The proposed study is a crossover 2- arm pilot study comparing vegetable consumption of
      individuals partaking in two interventions: 1) Tomato Products (tomato) or 2) Vegetables
      Prepared Raw (raw).

      A planned sample size of 20 will be recruited into the study. This study will require one
      initial screening visit and 5 weekly study visits. This study will take 4 weeks per subject
      to complete.

      The trial will initiate with one screening visit which will last about 1-2 hours where the
      subjects' height, weight, BMI, waist circumference, fasting glucose, blood pressure and heart
      rate will be measured along with a survey related to general eating, health and exercise
      habits.

      If willing and eligible to participate, a training of the online 24-hour recall software will
      be conducted during the screening visit. The subject will then use the software for an
      upcoming training week to recall foods for 3 days (2 weekdays and 1 weekend).

      During the first study visit (End of Week 0) the subject will be randomly assigned an
      intervention sequence. The intervention sequence will dictate which intervention will be
      conducted for the first two weeks, leaving the second intervention for the last two weeks.
      Subjects will receive detailed explanation of their role and types of products they must buy
      during the upcoming week for the purpose of the study. They will be taught how to record on
      Vegetable Intake Diaries and be provided with vouchers and coupons to buy study products.
      They will also be given a recipe book for inspiration during the study to make appropriate
      meals.

      The next study visits (End of Week 1-3) will take place by checking subjects' weight and then
      providing them with an Experience Questionnaire that is specific to their respective
      intervention assignment. The questionnaire will ask them to relate their study experiences
      over the past week. They will return any receipts and labels that were used to buy study
      products with the vouchers along with completed Vegetable Intake Diary. Before leaving,
      subjects will be provided with another set of Vegetable Intake Diaries and vouchers.

      During Week 2 and 4, subjects will receive 3 surprise notifications (2 weekdays and 1
      weekend) to complete the online food records. If they are unable to comply, a different day
      will be assigned.

      The final study visit (End of Week 4) will initiate with anthropometric and vital
      measurements (height, weight, BMI, heart rate and blood pressure). Subject will complete
      Experience Questionnaire and return all receipts, labels, and diaries.

      The randomization intervention sequence will be randomly assigned based on computer generated
      sequences. The primary difference between the intervention sequences is the order in which
      the subject will partake in the two intervention types. While in the tomato intervention,
      they will be asked to consume extra vegetable through tomato products. While in the raw
      intervention, however, they can only consume extra vegetables into their diet through raw
      vegetable products that have not been processed in any way.

      Weekly Study Visits will be scheduled approximately 7 days apart.
    

Intervention name(s): Tomato; Raw
Intervention type(s): Other; Other
Intervention description(s): Tomato Products (tomato); Vegetables Prepared Raw (raw).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other