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eCulinary Medicine Emphasizing Herbs/Spices to Increase Vegetable Intake

Primary Purpose

Hypertension, Diet, Healthy, Culinary Medicine

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-group
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis hypertension
  • Age above 18

Exclusion Criteria:

  • Use of tobacco
  • Self-reported history of chronic diseases other than hypertension
  • Allergy to any food
  • Pregnant or lactating
  • Alcohol or drug dependence

Sites / Locations

  • Texas Tech University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eCulinary Medicine Group (E-group)

Control Group (C-group)

Arm Description

The intervention group will receive weekly cooking demonstrations and education videos via electronic links to use herbs and spices to increase vegetables and reduce sodium in the diet over six weeks

The control group participants will receive usual care from their physician's clinic and the recipes but without the eCulinary intervention over 6 weeks.

Outcomes

Primary Outcome Measures

Dietary Intake
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Dietary Intake
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Dietary Intake
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Diet Quality
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Diet Quality
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Diet Quality
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Diet Quality
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Diet Quality
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Cooking effectiveness evaluation
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Cooking effectiveness evaluation
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Cooking effectiveness evaluation
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Cooking effectiveness evaluation
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.

Secondary Outcome Measures

Systolic or Diastolic Blood Pressure
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Systolic or Diastolic Blood Pressure
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Systolic or Diastolic Blood Pressure
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Systolic or Diastolic Blood Pressure
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Systolic or Diastolic Blood Pressure
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Body Weight
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Body Weight
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Body Weight
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Body Weight
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Body Weight
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.

Full Information

First Posted
September 16, 2022
Last Updated
May 26, 2023
Sponsor
Texas Tech University
Collaborators
McCormick and Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05587855
Brief Title
eCulinary Medicine Emphasizing Herbs/Spices to Increase Vegetable Intake
Official Title
Effects of eCulinary Medicine Emphasizing Herbs and Spices to Increase Vegetable Consumption Among Adults With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University
Collaborators
McCormick and Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
e-Culinary medicine emphasizes on herbs and spices, will increase consumption of vegetables and reduce sodium in the diets of people with hypertension and lead to a more favorable health profile.
Detailed Description
This will be a randomized controlled intervention in collaboration with physician care clinics. Participants with hypertension will be assigned to an eCulinary medicine group (E-group) or control that will receive recipes without the eCulinary intervention (C-group). The intervention group will receive weekly cooking demonstration videos, a one-time nutrition education session based on the content of the Nutrition Care Manual from the Academy of Nutrition and Dietetics, a bi-weekly phone visit, and will be given a digital blood pressure monitor and a digital weight scale. The cooking demonstrations will focus on utilizing herbs and spices in the preparation of various vegetables using different cooking methods aimed to reduce sodium and increase vegetable consumption. The control group will receive only recipes from the eCulinary intervention as well digital blood pressure monitor and a digital weight scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diet, Healthy, Culinary Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a 6-week randomized controlled intervention. Participants with hypertension will be assigned to an eCulinary medicine group (E-group) or control that will receive recipes without the eCulinary intervention (C-group).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCulinary Medicine Group (E-group)
Arm Type
Experimental
Arm Description
The intervention group will receive weekly cooking demonstrations and education videos via electronic links to use herbs and spices to increase vegetables and reduce sodium in the diet over six weeks
Arm Title
Control Group (C-group)
Arm Type
No Intervention
Arm Description
The control group participants will receive usual care from their physician's clinic and the recipes but without the eCulinary intervention over 6 weeks.
Intervention Type
Other
Intervention Name(s)
E-group
Intervention Description
Participants with Hypertension will be assigned to eCulinary medicine
Primary Outcome Measure Information:
Title
Dietary Intake
Description
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Time Frame
at baseline
Title
Dietary Intake
Description
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Time Frame
6 weeks
Title
Dietary Intake
Description
Dietary intake by National Cancer Institute Dietary Screener Questionnaire included a section with questions about 27 individual culinary herbs and spices. Scale is A-K and we use this to compare pre and post intervention for higher intakes of vegetables.
Time Frame
1 month post intervention
Title
Diet Quality
Description
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Time Frame
at baseline
Title
Diet Quality
Description
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Time Frame
2 weeks
Title
Diet Quality
Description
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Time Frame
4 weeks
Title
Diet Quality
Description
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Time Frame
6 weeks
Title
Diet Quality
Description
Diet quality using the Healthy Eating Index (HEI), a standardized scoring metric that can be used to score any set of foods to evaluate quality as compared to the Dietary Guidelines for Americans. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.
Time Frame
1 month post intervention
Title
Cooking effectiveness evaluation
Description
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Time Frame
2 weeks
Title
Cooking effectiveness evaluation
Description
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Time Frame
4 weeks
Title
Cooking effectiveness evaluation
Description
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Time Frame
6 weeks
Title
Cooking effectiveness evaluation
Description
A quantitative and qualitative evaluation of the eCulinary program, using a pre-test/post-test study and cooking effectiveness over time. The test asks questions regarding the recipes that were used, number of times a recipe was used, and if it was useful.
Time Frame
1 month post intervention
Secondary Outcome Measure Information:
Title
Systolic or Diastolic Blood Pressure
Description
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
at baseline
Title
Systolic or Diastolic Blood Pressure
Description
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
2 weeks
Title
Systolic or Diastolic Blood Pressure
Description
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
4 weeks
Title
Systolic or Diastolic Blood Pressure
Description
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
6 weeks
Title
Systolic or Diastolic Blood Pressure
Description
Participants will receive an Omron 3 Series Upper Arm Blood Pressure Monitor (HBPM) (Model BP7100). They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
1 month post intervention
Title
Body Weight
Description
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
at baseline
Title
Body Weight
Description
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
2 weeks
Title
Body Weight
Description
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
4 weeks
Title
Body Weight
Description
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
6 weeks
Title
Body Weight
Description
Participants will receive a Doran DS500 Digital Flat Floor Scale, instructions about using their device for home weight monitoring. They will be instructed to use their device to take readings to track over time and share with the researchers and health care providers.
Time Frame
1 month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis hypertension Age above 18 Exclusion Criteria: Use of tobacco Self-reported history of chronic diseases other than hypertension Allergy to any food Pregnant or lactating Alcohol or drug dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Galyean, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
(CDC) CfDCaP. Hypertension Cascade: Hypertension Prevalence, Treatment and Control Estimates Among US Adults Aged 18 Years and Older Applying the Criteria From the American College of Cardiology and American Heart Association's 2017 Hypertension Guideline-NHANES 2013-2016 2019 [cited 2021]. Available from: Million Hearts® (hhs.gov).
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