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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05499858
Other study ID # USUHS- 2022-105
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Uniformed Services University of the Health Sciences
Contact Jonathan M Scott, PhD
Phone 301-295-5428
Email jonathan.scott@usuhs.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

"The goal of this study is to evaluate whether the addition of spices and herbs to the vegetables served to military personnel on a large military base can increase vegetable intake as compared to typical vegetable offerings without spices and herbs. A two-phase intervention will be conducted on base at Naval Station Activity Bethesda (NSAB) to evaluate whether the addition of spices and herbs to vegetable dishes can increase vegetable intake amongst military service members. Phase I will involve extensive engagement with key stakeholders involved in current vegetable consumption at NSAB, including military service members, staff dietitians, the health promotion specialist on base, barracks managers, military culinary specialist, unit leaders, morale welfare and recreations/single sailor program leaders, base senior enlisted leaders, and the base commander. Questionnaires will be administered evaluating current barriers to vegetable intake at NSAB, familiarity with and liking of a variety of spices and herbs, and sensory testing of several vegetables with and without spices and herbs. The recipes in the vegetable sensory testing comparisons will be identical other than spices and herbs content. Phase II will involve will focus upon the direct measurement of vegetable intake (primary outcome) and vegetable linking (secondary outcome) among active-duty service members with spices and herbs and without spices and herbs. The vegetables will be provided as part of an entire meal on a "grab and go" plate. The other foods in the meal (proteins, starches, etc.) accompanying the vegetables will be kept consistently paired to vegetable recipes to minimize confounding. Vegetable intake will be assessed via cell phone pictures and liking will be assessed by a single 5-point Likert scale question."


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Junior Service Member (E1-E4 or O1-O3) - Read and write English Exclusion Criteria: - Anyone under 18 years of age - Anyone not in the U.S. military

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spiced
Vegetables provided to volunteers will be spiced.
Plain
Vegetables provided to volunteers will be plain.

Locations

Country Name City State
United States Naval Support Activity Bethesda Bethesda Maryland

Sponsors (6)

Lead Sponsor Collaborator
Uniformed Services University of the Health Sciences Henry M. Jackson Foundation for the Advancement of Military Medicine, McCormick Science Institute, Nova Institute for Health, Pennington Biomedical Research Center, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (3)

D'Adamo CR, McArdle PF, Balick L, Peisach E, Ferguson T, Diehl A, Bustad K, Bowden B, Pierce BA, Berman BM. Spice MyPlate: Nutrition Education Focusing Upon Spices and Herbs Improved Diet Quality and Attitudes Among Urban High School Students. Am J Health Promot. 2016 May;30(5):346-56. doi: 10.1177/0890117116646333. — View Citation

D'Adamo CR, Parker EA, McArdle PF, Trilling A, Bowden B, Bahr-Robertson MK, Keller KL, Berman BM. The addition of spices and herbs to vegetables in the National School Lunch Program increased vegetable intake at an urban, economically-underserved, and predominantly African-American high school. Food Qual Prefer. 2021 Mar;88:104076. doi: 10.1016/j.foodqual.2020.104076. Epub 2020 Sep 1. — View Citation

Pierce B, Bowden B, McCullagh M, Diehl A, Chissell Z, Rodriguez R, Berman BM, D Adamo CR. A Summer Health Program for African-American High School Students in Baltimore, Maryland: Community Partnership for Integrative Health. Explore (NY). 2017 May-Jun;13(3):186-197. doi: 10.1016/j.explore.2017.02.002. Epub 2017 Feb 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Vegetable consumption Volunteers will provided with a heat and serve meal kit. Using the food photography mobile application (SmartIntake), volunteers will take a single photo of the meal kit after they have consumed a self-determined desired amount of food. The digital photo will be sent to Pennington Biomedical Research Center (PBRC) for analysis via the SmartIntake app. The team at PBRC will download the image and use a validated algorithm to estimate, in cups, the remaining vegetable component from the meal kit. Volunteers will be provided with a series of heat and serve meal kits over approximately 2 month time period.
Primary Phase I - Primary Outcome: United States Military - Menu Item Survey Overall liking of menu item, specific ratings of the appearance, aroma, flavor, texture, and overall appeal of the menu item, and qualitative feedback on general impressions of the menu item Volunteers will be provided with a series of 8 recipes to evaluate over the course of a single taste testing session through study completion, an average of 1 year.
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