- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05587855
eCulinary Medicine Emphasizing Herbs/Spices to Increase Vegetable Intake
May 26, 2023 updated by: Shannon Galyean, Texas Tech University
Effects of eCulinary Medicine Emphasizing Herbs and Spices to Increase Vegetable Consumption Among Adults With Hypertension
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Galyean
- Phone Number: 806-535-2492
- Email: shannon.galyean@ttu.edu
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Texas Tech University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eCulinary Medicine Group (E-group)
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
|
Participants with Hypertension will be assigned to eCulinary medicine
|
No Intervention: Control Group (C-group)
The control group participants will receive usual care from their physician's clinic and the recipes but without the eCulinary intervention over 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Intake
Time Frame: at baseline
|
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.
|
at baseline
|
Dietary Intake
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Dietary Intake
Time Frame: 1 month post intervention
|
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.
|
1 month post intervention
|
Diet Quality
Time Frame: at baseline
|
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.
|
at baseline
|
Diet Quality
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Diet Quality
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Diet Quality
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Diet Quality
Time Frame: 1 month post intervention
|
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.
|
1 month post intervention
|
Cooking effectiveness evaluation
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Cooking effectiveness evaluation
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Cooking effectiveness evaluation
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Cooking effectiveness evaluation
Time Frame: 1 month post intervention
|
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.
|
1 month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic or Diastolic Blood Pressure
Time Frame: at baseline
|
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.
|
at baseline
|
Systolic or Diastolic Blood Pressure
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Systolic or Diastolic Blood Pressure
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Systolic or Diastolic Blood Pressure
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Systolic or Diastolic Blood Pressure
Time Frame: 1 month post intervention
|
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.
|
1 month post intervention
|
Body Weight
Time Frame: at baseline
|
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.
|
at baseline
|
Body Weight
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Body Weight
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Body Weight
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Body Weight
Time Frame: 1 month post intervention
|
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.
|
1 month post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shannon Galyean, PhD, Texas Tech University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.
- Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available. Erratum In: Hypertension. 2018 Jun;71(6):e136-e139. Hypertension. 2018 Sep;72(3):e33.
- (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).
- Aburto NJ, Ziolkovska A, Hooper L, Elliott P, Cappuccio FP, Meerpohl JJ. Effect of lower sodium intake on health: systematic review and meta-analyses. BMJ. 2013 Apr 3;346:f1326. doi: 10.1136/bmj.f1326.
- Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, Goldman L. Projected effect of dietary salt reductions on future cardiovascular disease. N Engl J Med. 2010 Feb 18;362(7):590-9. doi: 10.1056/NEJMoa0907355. Epub 2010 Jan 20.
- Palar K, Sturm R. Potential societal savings from reduced sodium consumption in the U.S. adult population. Am J Health Promot. 2009 Sep-Oct;24(1):49-57. doi: 10.4278/ajhp.080826-QUAN-164.
- Fritts JR, Fort C, Quinn Corr A, Liang Q, Alla L, Cravener T, et al. Herbs and spices increase liking and preference for vegetables among rural high school students. Food Quality and Preference. 2018;68:125-34. doi: https://doi.org/10.1016/j.foodqual.2018.02.013.
- Anderson CA, Cobb LK, Miller ER 3rd, Woodward M, Hottenstein A, Chang AR, Mongraw-Chaffin M, White K, Charleston J, Tanaka T, Thomas L, Appel LJ. Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial. Am J Clin Nutr. 2015 Sep;102(3):671-9. doi: 10.3945/ajcn.114.100750. Epub 2015 Aug 12.
- Wang C, Lee Y, Lee SY. Consumer acceptance of model soup system with varying levels of herbs and salt. J Food Sci. 2014 Oct;79(10):S2098-106. doi: 10.1111/1750-3841.12637. Epub 2014 Sep 12.
- Ghawi SK, Rowland I, Methven L. Enhancing consumer liking of low salt tomato soup over repeated exposure by herb and spice seasonings. Appetite. 2014 Oct;81:20-9. doi: 10.1016/j.appet.2014.05.029. Epub 2014 May 28.
- Aburto NJ, Hanson S, Gutierrez H, Hooper L, Elliott P, Cappuccio FP. Effect of increased potassium intake on cardiovascular risk factors and disease: systematic review and meta-analyses. BMJ. 2013 Apr 3;346:f1378. doi: 10.1136/bmj.f1378.
- Services USDoAaUSDoHaH. Dietary Guidelines for Americans, 2020-2025 2020 [cited 2021].
- Kimmons J, Gillespie C, Seymour J, Serdula M, Blanck HM. Fruit and vegetable intake among adolescents and adults in the United States: percentage meeting individualized recommendations. Medscape J Med. 2009;11(1):26. Epub 2009 Jan 26.
- Lucan SC, Barg FK, Long JA. Promoters and barriers to fruit, vegetable, and fast-food consumption among urban, low-income African Americans--a qualitative approach. Am J Public Health. 2010 Apr;100(4):631-5. doi: 10.2105/AJPH.2009.172692. Epub 2010 Feb 18.
- Casagrande SS, Gary-Webb TL. Chapter 8 - Trends in US Adult Fruit and Vegetable Consumption. In: Watson RR, Preedy VR, editors. Bioactive Foods in Promoting Health. San Diego: Academic Press; 2010. p. 111-30.
- Kalantar-Zadeh K, Mattix-Kramer HJ, Moore LW. Culinary Medicine as a Core Component of the Medical Nutrition Therapy for Kidney Health and Disease. J Ren Nutr. 2021 Jan;31(1):1-4. doi: 10.1053/j.jrn.2020.11.002. No abstract available.
- Brors G, Pettersen TR, Hansen TB, Fridlund B, Holvold LB, Lund H, Norekval TM. Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review. BMC Health Serv Res. 2019 Jun 10;19(1):364. doi: 10.1186/s12913-019-4106-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2021
Primary Completion (Actual)
April 30, 2023
Study Completion (Estimated)
August 30, 2023
Study Registration Dates
First Submitted
September 16, 2022
First Submitted That Met QC Criteria
October 17, 2022
First Posted (Actual)
October 20, 2022
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2021-446
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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