Source: OKLAHOMA STATE UNIVERSITY submitted to NRP
DETERMINANTS AND OUTCOMES OF HIGH VS. LOW ULTRA-PROCESSED FEEDING
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
Reporting Frequency
Annual
Accession No.
1030193
Grant No.
2023-69015-39600
Cumulative Award Amt.
$175,217.00
Proposal No.
2022-08665
Multistate No.
(N/A)
Project Start Date
Jul 1, 2023
Project End Date
Jun 30, 2026
Grant Year
2023
Program Code
[A1344]- Diet, Nutrition and the Prevention of Chronic Disease
Recipient Organization
OKLAHOMA STATE UNIVERSITY
(N/A)
STILLWATER,OK 74078
Performing Department
(N/A)
Non Technical Summary
The eating patterns of U.S. adults are characterized by increased ultra-processed foods (UPF) and few raw agricultural commodities (i.e., minimally processed foods), which can encourage excessive energy intake, increasing the risk of diet-related chronic diseases. What is currently unknown is the extent to which adults can maintain consumption of a low UPF diet in free living conditions after receiving education, and if successfully doing so would improve eating patterns, eating behavior, and health. The objective of this project is to characterize if and how individuals are able to minimize UPF consumption in free-living conditions, and to use these data to develop an educational phone application ("app") to support individuals in decreasing UPF consumption, improving eating patterns, and improving biomarkers of disease risk. The central hypothesis is that individuals will achieve decreases in their UPF consumption in response to intervention, but will report challenges in doing so related to social and environmental influences. The specific research objectives are to determine the impact of attempted consumption of a minimally processed diet on adherence to the U.S. Dietary Guidelines, eating behavior, energy balance, health outcomes, and tendency toward obesity over time; evaluate and understand facilitators and barriers central to avoiding UPF; and develop and test an app to assist individuals in minimizing UPF consumption.
Animal Health Component
75%
Research Effort Categories
Basic
0%
Applied
75%
Developmental
25%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
70350101010100%
Knowledge Area
703 - Nutrition Education and Behavior;

Subject Of Investigation
5010 - Food;

Field Of Science
1010 - Nutrition and metabolism;
Goals / Objectives
The overall goalof this project is to characterize if and how individuals are able to minimize their consumption of ultra-processed foods (UPF) in free-living conditions, and to use these data to develop an empirically-driven educational phone application ("app") to support individuals in decreasing UPF consumption and improving overall eating patterns and biomarkers of chronic disease risk. The central hypothesis informing this work is that individuals will achieve decreases in their consumption of UPF in response to intervention, but will report challenges in doing so related to social and environmental influences. The following objectives will test this hypothesis:Objective 1. Determine the impact of attempted consumption of a minimally processed diet on adherence to the United States Dietary Guidelines for Americans (i.e., HEI), eating behavior, energy balance, downstream health outcomes, and tendency toward obesity over time. Objective 2. Conduct a mixed methods evaluation to understand facilitators and barriers central to successfully or unsuccessfully adopting a minimally processed diet among rural, underserved, and/or food insecure adults.Objective 3. Develop and conduct a user-centered evaluation of a consumer-friendly resource/instructional tool to facilitate the consumption of a minimally processed diet.
Project Methods
Objective 1. Determine the impact of attempted consumption of a minimally processed diet on adherence to the United States Dietary Guidelines for Americans (i.e., HEI), eating behavior, energy balance, downstream healthoutcomes,and tendency toward obesity over time.Experimental Design. We will conduct a 1-year study assessing impacts of attempted consumption of a minimally processed diet. After a baseline observation period, participants will be randomized to consume either their normal diet (control group) or a minimally processed diet (intervention group). The control group will be instructed to continue consuming their normal diet for the next 12 months. The intervention group will be instructed to consume a diet that is as low in ultra-processed foods (UPF) as possible for next 6 months. Participants in the intervention group will receive regular guidance and support from research personnel with regard to consuming a minimally processed diet. After 6 months, intervention group participants will be passively followed for an additional 6 months to observe potential dietary changes relative to baseline and the control group. A 3-day food record will be completed by all participants at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months. Body composition, resting metabolic rate, physical activity, metabolic markers, and gut microbiome outcomes will be measured at baseline, 6 months, and 12 months.Diet intervention and measurement. After completion of a baseline 3-day food record, participants will be randomized to either the control (normal diet) or intervention (minimally processed diet) group. Both groups will complete 3-day diet records at 1, 3, 6, 9, and 12 months. The control group will be instructed to continue their regular diet. The intervention group will be instructed to consume a diet that is as low in processed and UPF as possible - that is, to the extent possible, consume no processed or UPF (i.e., NOVA categories 3 and 4).Prior to initiating the diet, a member of the research team (specifically, a registered dietitian) will explain in detail the premise of consuming a minimally processed diet. Participants will be provided a handout, as well as a QR code to an online list of foods and their NOVA category.Energy balance, metabolism, and physical activity. Free living physical activity energy expenditure will be estimated using accelerometers (Actigraph wGT3X-BT) for 3 days. Resting metabolic rate will be assessed using indirect calorimetry with a canopy hood system (Parvo Medics TrueOne 2400). These measurements will be used to estimate total energy expenditure. Energy intake will be estimated using a 3-day diet record. These measurements of energy expenditure and intake will allow crude assessment of propensity toward energy balance or imbalance (i.e., energy surplus or energy deficit) in the diet trials.Health outcomes. We will assess body composition with a Hologic Horizon A dual-energy X ray absorptiometry (DEXA) scanner. This measurement allows the determination of bone mineral density, lean mass and fat mass, including visceral adipose tissue. Whole blood samples obtained via single venipuncture will be used to measure metabolic markers via the Piccolo Xpress clinical chemistry analyzer (Abbott) with Lipid Panel Plus reagent discs. We will measure fasting triglycerides, glucose, HDL, total cholesterol, ALT and AST, as well as calculate LDL and VLDL. Fecal samples will be collected with the ALPCO Easy Sampler stool collection kit. Samples will be processed and stored at -80 Cº. When data collection is complete, samples will be shipped to Zymo Research for 16S rRNA sequencing. This service includes bioinformatics analysis and support, such as clustering analysis, within-sample α-diversity analysis, between-sample β-diversity analysis, principal component plots, and distance analysis.Statistical analyses. Data will be checked for normality prior to analysis. Non-normal data will be transformed. A two-way repeated measures analysis of variance will be used to determine group- and time-based differences, as well as interactions, in key outcomes: diet quality, energy intake, metabolic health markers, body composition parameters, and gut health outcomes. If significant interactions and/or main effects are detected, a Tukey's post hoc analysis will be conducted to determine pairwise differences.Objective 2. Conduct a mixed methods evaluation to understand facilitators and barriers central to successfully or unsuccessfully adopting a minimally processed diet among rural, underserved, and/or food insecure adults.Experimental Design. We will conduct qualitative semi-structured interviews (SSI) to explain and contextualize our quantitative findings, yielding a mixed methods study design. At the cessation of the 6-month intervention (Objective 1), intervention participants will be invited to complete a SSI with research personnel conducted via phone call or Zoom. Questioning routes will be tailored according to response to intervention. Specifically, individual consumption of UPF will be quantified according to percent of calories consumed from UPF, and individuals split into quartiles. Further, we will identify whether individuals decreased, increased, or had no change in consumption of UPF. Questions will assess overall experiences and relative success in modifying UPF consumption (e.g., "How were you able to successfully lower your UPF consumption in the past 6 months?") or challenges (e.g., "What was it like trying to decrease how much UPF you ate?") per the quantitative data.Statistical analysis. The theoretical framework informing our analysis is an adaptation of the Theory of Planned Behavior which incorporates the role of hedonics (e.g., taste and pleasure) in driving food choices.For analysis, interviews will be transcribed verbatim and two members of the research team will independently review a subset of interviews using deductive content analysis to establish a preliminary codebook and optimal percent agreement (i.e., 80%) in assigning codes using this codebook. Emergent themes inconsistent with this framework will also be captured. Coding of transcripts will occur iteratively until 80% agreement is achieved, after which one member of the research team will finish coding all transcripts and enter the data into NVivo. Findings will be consolidated to demonstrate frequency of codes, and themes will be compiled into coding matrices to match to complementary intervention strategies which can be integrated in to the app platform in Objective 3.Objective 3. Develop and conduct a user-centered evaluation of a consumer-friendly resource/instructional tool to facilitate the consumption of a minimally processed diet.App design process. After obtaining the qualitative feedback in Objective 2, we will first develop a sitemap for the mobile application which will list all the pages anticipated in the mobile app in its hierarchical fashion. After the sitemap is completed, wireframe of each page of the mobile application will be developed. The wireframe contains the page layout of the application content, including interface elements and navigational systems. The key features in the app will dictate how the page is defined in the wireframe. User Interface (UI) and User Experience (UX) design will be performed next for each of the wireframed pages. Each of the pages will be designed with iconography, fonts, and other visual objects to create a cohesive mobile app experience to produce the desired outcome.

Progress 07/01/23 to 06/30/24

Outputs
Target Audience:During this period, we were exclusively focused on research. We recruited and enrolled participants for the randomized trial. Therefore, the only target audience was prospective research participants. We reached this audience through recruitment efforts. Once enrolled, we aimed to provide benefits to this audience by providing them with their health data collected through research activities. Changes/Problems:Approximately 60% through participant enrollment, recruitment slowed. In order to meet enrollment goals this period, we made an internal budget modification to increase funds for participant payments while decreasing salary funds. This change allowed us to pay participants more money, which spurred recruitment and enrollment, allowing us to meet our recruitment and enrollment goal. What opportunities for training and professional development has the project provided?Three students are actively involved with this project: one graduate (PhD) student and two undergraduate students. This project has provided valuable opportunities to train the PhD student on how to conduct a randomized nutrition trial. This students aspires to be a research faculty.The student is involved in every aspect of the study, including recruitment and enrollment, data collection, data management and entry, participant engagement and communication, results dissemination, and mentorship of undergraduate students. Specifically, the graduate student will be able to attend a professional meeting and present preliminary data from theproject this summer.The undergraduate students have receive professional development and training by helping with data collection and data entry, as well as receiving mentorshipfrom the PD and graduate student. They learn about proper data collection techniques, how to engage with participants, the importance of scientific rigor, and how to manage a large dataset. How have the results been disseminated to communities of interest?No results have been formally disseminated. However, we had an abstract accepted for presentation at Nutrition 2024, the annual meeting for the American Society for Nutrition. These results will be presented July 1, 2024 by the graduate student, and therefore we will list this as a product for the next reporting period. What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, we aim to complete data collection. Since we enrolled all 60 participants during this period, the trial should be complete next period. This will position us to analyze data and develop results and conclusions next period, so that we can disseminate results. Thus, we are on track to complete Objectives 1 and 2 next reporting period. Objective 3 is dependent on timely completion of Objective 2, which involves follow-up interviews at 6-months with intervention participants. These interviews should be complete in November 2024 (i.e., several months in to next reporting period). We will then gather and analyze the feedback recieved in Objective 2 to inform Objective 3, development of an instructional resource or tool to help people eat a minimally processed diet. This will be a key focus during the second half of next reporting period.

Impacts
What was accomplished under these goals? During this project period, we focused on the randomized trial (Objective 1), including completion of 6-month follow-up interviews (Objective 2). We were successful in recruiting and enrolling the entire cohort (60 participants; 30 women and 30 men) during this period. Enrollment began in August 2023 on a rolling basis and concluded in May 2024. The entire cohort has completed baseline and 1-month testing. Approximately 25% of the cohort has completed 6-month testing. Since this is a 1-year trial, data collection will be complete in May 2025. Although data is organized and entered as we go, we do not have any results or conclusions to speak to related to the project's objectives since data collection is not complete. However, we are making sound progress toward completing all objectives. We are collecting all of the needed samples and variables for completion of Objective 1. We are conducting 6-month follow-up interviews as participants hit this checkpoint, which will be the basis for completion of Objective 2. We will then use feedback drawn from these interviews to inform Objective 3, development of a user-friendly resource to facilitate consumption of a minimally processed diet.

Publications