NCT05587855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

September 16, 2022

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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.

    at baseline

  • 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.

    6 weeks

  • 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.

    1 month post intervention

  • 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.

    at baseline

  • 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.

    2 weeks

  • 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.

    4 weeks

  • 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.

    6 weeks

  • 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.

    1 month post intervention

  • 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.

    2 weeks

  • 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.

    4 weeks

  • 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.

    6 weeks

  • 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.

    1 month post intervention

Secondary Outcomes (10)

  • Systolic or Diastolic Blood Pressure

    at baseline

  • Systolic or Diastolic Blood Pressure

    2 weeks

  • Systolic or Diastolic Blood Pressure

    4 weeks

  • Systolic or Diastolic Blood Pressure

    6 weeks

  • Systolic or Diastolic Blood Pressure

    1 month post intervention

  • +5 more secondary outcomes

Study Arms (2)

eCulinary Medicine Group (E-group)

EXPERIMENTAL

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

Other: E-group

Control Group (C-group)

NO INTERVENTION

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

Interventions

E-groupOTHER

Participants with Hypertension will be assigned to eCulinary medicine

eCulinary Medicine Group (E-group)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis hypertension
  • Age above 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (17)

  • (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).

    BACKGROUND
  • 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.

    PMID: 29133354BACKGROUND
  • 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.

    PMID: 23558163BACKGROUND
  • 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.

    PMID: 20089957BACKGROUND
  • 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.

    PMID: 19750962BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26269371BACKGROUND
  • 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.

    PMID: 25220863BACKGROUND
  • 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.

    PMID: 24879887BACKGROUND
  • 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.

    PMID: 23558164BACKGROUND
  • Services USDoAaUSDoHaH. Dietary Guidelines for Americans, 2020-2025 2020 [cited 2021].

    BACKGROUND
  • 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.

    PMID: 19295947BACKGROUND
  • 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.

    PMID: 20167885BACKGROUND
  • 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.

    PMID: 31543284BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33357519BACKGROUND
  • 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.

    PMID: 31182100BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Shannon Galyean, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/Registered Dietitian Nutritionist

Study Record Dates

First Submitted

September 16, 2022

First Posted

October 20, 2022

Study Start

July 30, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations