- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05499858
Evaluating Effectiveness of Spices and Herbs to Increase Vegetable Intake Among Military
"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."
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan M Scott, PhD
- Phone Number: 301-295-5428
- Email: jonathan.scott@usuhs.edu
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20814
- Recruiting
- Naval Support Activity Bethesda
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Contact:
- Commanding Officer
- Phone Number: 301-319-8897
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Vegetables
Vegetables will be provided to volunteers as part of a heat and serve meal kit.
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Vegetables provided to volunteers will be spiced.
Vegetables provided to volunteers will be plain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vegetable consumption
Time Frame: Volunteers will be provided with a series of heat and serve meal kits over approximately 2 month time period.
|
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.
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Volunteers will be provided with a series of heat and serve meal kits over approximately 2 month time period.
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Phase I - Primary Outcome: United States Military - Menu Item Survey
Time Frame: 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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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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chris D'Adamo, PhD, Assistant Professor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- USUHS- 2022-105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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