Patient-Centered Outcomes and Key Study Procedure Finalization in the Pilot Feasibility Gout Randomized Trial: Comparative Feasibility Study in GOUt, CHerry Extract Versus Diet Modification (Mini-GOUCH).

OBJECTIVE: The aim of this study was to report patient-centered outcomes and finalization of key study procedures from a 9-month pilot internet randomized controlled trial of cherry extract versus diet modification. METHODS: We randomized 84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via internet and phone calls. We finalized key study procedures. We assessed acceptability and feasibility of the intervention and satisfaction with study website. RESULTS: Study participant satisfaction with the intervention was high. The intervention was perceived as easy, enjoyable, understandable, and helpful (scores 65-88 for all; higher = better). The amount of time spent for the study was acceptable. Participant satisfaction with website interaction and content was very high; 85% or more were moderately to extremely satisfied. Significantly lower total calories, total carbohydrate, and saturated fat intake were noted at 6 months in the diet modification versus cherry extract group; differences were insignificant at 9 months. Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group. Key study procedures were finalized for a future trial, including an internet diet assessment tool, gout flare assessment, provider confirmation of gout diagnosis, patient reporting of classification criteria, and centralized laboratory-assisted serum urate testing. CONCLUSIONS: High patient acceptability and feasibility of study/intervention and finalization of key study procedures indicate that hypothesis-testing internet gout trials of cherry extract and/or diet modification can be conducted in the future.

A Randomized Internet-Based Pilot Feasibility and Planning Study of Cherry Extract and Diet Modification in Gout.

OBJECTIVE: The aim of this study was to conduct a 9-month pilot Internet randomized controlled trial (RCT) of cherry extract and diet modification in gout to assess the feasibility of an Internet study and obtain effect estimates. METHODS: After providing online informed consent in response to Internet advertisements and social media or clinic flyers, 84 people with physician-confirmed gout were randomized to either cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via Internet and phone calls. The primary objective was the feasibility of an Internet study, and secondary objectives were to obtain effect estimates for gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future trials. RESULTS: Of the 84 people randomized, overall completion rates were more than 80% for most study procedures up to 6 months and similar for the 2 active comparators. Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean ± standard deviation HAQ score, 0.28 ± 0.54 versus 0.55 ± 0.68 (p = 0.001) and 0.23 ± 0.40 versus 0.48 ± 0.61 (p = 0.06), respectively. Any AEs and gastrointestinal symptoms/AEs at 9 months in cherry extract and diet modification groups were 3% versus 0% and 28% versus 27%, respectively. CONCLUSIONS: An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed.

Identifying the Leading Sources of Saturated Fat and Added Sugar in U.S. Adults.

The 2020-2025 Dietary Guidelines for Americans recommend limiting intakes of saturated fat and added sugars (SF/AS) to <10% total energy. Data-driven approaches to identify sources of SF/AS are needed to meet these goals. We propose using a population-based approach to identify the leading food and beverage sources of SF/AS consumed by US adults. Foods and beverages reported as consumed were assessed from two, 24 h dietary recalls (24HRDR) from 36,378 adults aged 19 years and older from the 2005-2018 National Health and Nutrition Examination Survey. Intakes of SF/AS were aggregated across both 24HRDR to identify What We Eat in America food categories accounting for ≥90% of SF/AS, respectively, by the total population and within population subgroups. Data were weighted to estimate a nationally representative sample. Ninety-five discrete food categories accounted for ≥90% of the total SF/AS intakes for >88% of the representative sample of U.S. adults. The top sources of SF were cheese, pizza, ice cream, and eggs. The leading sources of AS were soft drinks, tea, fruit drinks, and cakes and pies. This analysis reflects a parsimonious approach to reliably identify foods and beverages that contribute to SF/AS intakes in U.S. adults.

Development of a Food List to Assess the Diet of South Asians Living in the U.S.: Preliminary Results From a Formative Study.

Introduction: South Asians are an underrepresented population subgroup in the U.S., yet they have higher rates of chronic diseases. There is currently no tool that assesses the nutrition intake of South Asians in the U.S., despite their unique dietary profile that may be associated with disease outcomes. The objective of this preliminary study was to create a food list, inclusive of herbs and spices, that will be used in the development of the web-based South Asian Food Intake System for dietary assessment of South Asian adults living in the U.S. Methods: Authors used a Qualtrics survey to collect sociodemographic information (n=66), and 24-hour diet recall and Home Food Inventory interviews were conducted through Zoom (n=31). Grocery store tours and cookbook and existing food frequency questionnaire review were conducted. Results: A food list of 484 individual food items was generated. These items were sorted into 12 main food categories and condensed into 302 line items. Most respondents (68%) reported consuming South Asian meals regularly and utilizing herbs/spices during food preparation (83%). Conclusions: This pilot study describes the data collection to develop a food list for the South Asian Food Intake System, which can be utilized by educators, clinicians, and researchers to more accurately collect information about dietary intake among South Asian Americans.

Abbreviated Dietary Self-monitoring for Type 2 Diabetes Management: Mixed Methods Feasibility Study.

BACKGROUND: Type 2 diabetes mellitus (T2D) can be managed through diet and lifestyle changes. The American Diabetes Association acknowledges that knowing what and when to eat is the most challenging aspect of diabetes management. Although current recommendations for self-monitoring of diet and glucose levels aim to improve glycemic stability among people with T2D, tracking all intake is burdensome and unsustainable. Thus, dietary self-monitoring approaches that are equally effective but are less burdensome should be explored. OBJECTIVE: This study aims to examine the feasibility of an abbreviated dietary self-monitoring approach in patients with T2D, in which only carbohydrate-containing foods are recorded in a diet tracker. METHODS: We used a mixed methods approach to quantitatively and qualitatively assess general and diet-related diabetes knowledge and the acceptability of reporting only carbohydrate-containing foods in 30 men and women with T2D. RESULTS: The mean Diabetes Knowledge Test score was 83.9% (SD 14.2%). Only 20% (6/30) of participants correctly categorized 5 commonly consumed carbohydrate-containing foods and 5 noncarbohydrate-containing foods. The mean perceived difficulty of reporting only carbohydrate-containing foods was 5.3 on a 10-point scale. Approximately half of the participants (16/30, 53%) preferred to record all foods. A lack of knowledge about carbohydrate-containing foods was the primary cited barrier to acceptability (12/30, 40%). CONCLUSIONS: Abbreviated dietary self-monitoring in which only carbohydrate-containing foods are reported is likely not feasible because of limited carbohydrate-specific knowledge and a preference of most participants to report all foods. Other approaches to reduce the burden of dietary self-monitoring for people with T2D that do not rely on food-specific knowledge could be more feasible.

Web-enabled and improved software tools and data are needed to measure nutrient intakes and physical activity for personalized health research.

Food intake, physical activity (PA), and genetic makeup each affect health and each factor influences the impact of the other 2 factors. Nutrigenomics describes interactions between genes and environment. Knowledge about the interplay between environment and genetics would be improved if experimental designs included measures of nutrient intake and PA. Lack of familiarity about how to analyze environmental variables and ease of access to tools and measurement instruments are 2 deterrents to these combined studies. This article describes the state of the art for measuring food intake and PA to encourage researchers to make their tools better known and more available to workers in other fields. Information presented was discussed during a workshop on this topic sponsored by the USDA, NIH, and FDA in the spring of 2009.

Diet Quality, Carotenoid Status, and Body Composition in NCAA Division I Athletes.

Objectives: In this paper, we examined diet quality and associations between changes in skin carotenoids and body composition among selected NCAA Division I athletes. Methods: Athletes from women's (rowing, swimming, gymnastics) and men's (swimming, wrestling) teams at a large Midwest university (N = 129) completed one online food frequency questionnaire and 2 in-person visits, once in-season and once out-of-season, to assess skin carotenoids and body composition. Diet quality was assessed via Healthy Eating Index-2015 (HEI). Carotenoids were measured via resonance Raman spectroscopy and body composition via dual-energy x-ray absorptiometry. ANOVA and Pearson correlations were used to test differences between teams and determine association between changes from in-season to out-of-season. Results: Mean HEI score for all athletes was 71.0. Women's rowing reported the highest diet quality (73.5), men's wrestling lowest (56.5). Skin carotenoids decreased for all teams, except men's wrestling, from in-season to out-of-season. Body fat percentage increased for women and decreased for men. There was a moderate inverse association between changes in skin carotenoids and body fat percentage (r = -.334, p = .001). Conclusions: Suboptimal diet quality coupled with decreases in skin carotenoids and increases in body fat percentage from in-season to out-of-season may justify dietitian-led interventions year-round to improve dietary patterns in collegiate athletes.

Relative validity and reliability of a diet risk score (DRS) for clinical practice.

INTRODUCTION: Adherence to cardioprotective dietary patterns can reduce risk for developing cardiometabolic disease. Rates of diet assessment and counselling by physicians are low. Use of a diet screener that rapidly identifies individuals at higher risk due to suboptimal dietary choices could increase diet assessment and brief counselling in clinical care. METHODS: We evaluated the relative validity and reliability of a 9-item diet risk score (DRS) based on the Healthy Eating Index (HEI)-2015, a comprehensive measure of diet quality calculated from a 160-item, validated food frequency questionnaire (FFQ). We hypothesised that DRS (0 (low risk) to 27 (high risk)) would inversely correlate with HEI-2015 score. Adults aged 35 to 75 years were recruited from a national research volunteer registry (ResearchMatch.org) and completed the DRS and FFQ in random order on one occasion. To measure reliability, participants repeated the DRS within 3 months. RESULTS: In total, 126 adults (87% female) completed the study. Mean HEI-2015 score was 63.3 (95% CI: 61.1 to 65.4); mean DRS was 11.8 (95% CI: 10.8 to 12.8). DRS and HEI-2015 scores were inversely correlated (r=-0.6, p<0.001; R2=0.36). The DRS ranked 37% (n=47) of subjects in the same quintile, 41% (n=52) within ±1 quintile of the HEI-2015 (weighted κ: 0.28). The DRS had high reliability (n=102, ICC: 0.83). DRS mean completion time was 2 min. CONCLUSIONS: The DRS is a brief diet assessment tool, validated against a FFQ, that can reliably identify patients with reported suboptimal intake. Future studies should evaluate the effectiveness of DRS-guided diet assessment in clinical care. Trial registration details ClinicalTrials.gov (NCT03805373).

Nutrition Counseling for Hypertension Within a Grocery Store: An Example of the Patient-Centered Medical Neighborhood Model.

OBJECTIVE: To evaluate the effectiveness of nutrition counseling for patients with hypertension, provided in a grocery store setting. DESIGN: Single-arm pretest-posttest design implementing a 12-week dietary intervention. SETTING: Grocery store. PARTICIPANTS: Thirty adults with hypertension recruited from a primary care practice. INTERVENTION: Registered dietitian nutritionists provided counseling based on the Dietary Approaches to Stop Hypertension diet. MAIN OUTCOME MEASURES: Dietary intake patterns and Healthy Eating Index-2010 (HEI-2010) scores measured via food-frequency questionnaire. Change in systolic blood pressure (SBP) was a secondary outcome. ANALYSIS: Paired t tests were used to test for differences between HEI-2010 scores, intake of key food pattern components, and SBP at baseline compared with follow-up. Statistical significance was established at P ≤ .05. RESULTS: Eight HEI-2010 component scores increased significantly from baseline to follow-up (a change toward a more desirable eating pattern): total fruit, whole fruit, greens and beans, whole grains, fatty acids, refined grains, and empty calories. Sodium (P < .001), saturated fat (P < .001), discretionary solid fat (P < .001), added sugars (P = .01), and total fat (P < .001) all decreased significantly. The change in SBP was not significant. CONCLUSIONS AND IMPLICATIONS: Grocery store-based counseling for patients with hypertension may be an effective strategy to provide lifestyle counseling that is not typically available within primary care.

Development of a Technology-Assisted Food Frequency Questionnaire for Elementary and Middle School Children: Findings from a Pilot Study.

BACKGROUND: This pilot study collected preliminary data for the modification of the VioScreen Food Frequency Questionnaire (FFQ), an adult-validated, self-administered, web-based dietary assessment tool for use in older children. METHODS: A convenience sample of 55 children, aged 6-14 years, completed the VioScreen FFQ and 3-day diet record (reference standard). Caregivers completed a short sociodemographic questionnaire. Reported dietary intakes from the VioScreen FFQ and 3-day diet record were calculated using standard nutrient databases, and descriptive statistics were used to examine differences in food/beverage items and portion sizes between the two methods. Informal focus groups obtained user feedback and identified components of the VioScreen FFQ that required modifications. RESULTS: The highest de-attenuated Pearson correlation coefficients between the VioScreen FFQ and 3-day diet record were observed for iron (r = 0.69), saturated fat (r = 0.59), and vegetables (r = 0.56), and the lowest were for whole grains (r = 0.11) and vitamin C (r = 0.16). Qualitative feedback was overall positive, and six technological modifications were identified. CONCLUSION: Findings from this pilot study provided valuable information on the process of evaluating the use of the VioScreen FFQ among older children, and will inform the future development of a modified version for this population.

Dietary Intake and Physical Activity Assessment: Current Tools, Techniques, and Technologies for Use in Adult Populations.

Accurate assessment of dietary intake and physical activity is a vital component for quality research in public health, nutrition, and exercise science. However, accurate and consistent methodology for the assessment of these components remains a major challenge. Classic methods use self-report to capture dietary intake and physical activity in healthy adult populations. However, these tools, such as questionnaires or food and activity records and recalls, have been shown to underestimate energy intake and expenditure as compared with direct measures like doubly labeled water. This paper summarizes recent technological advancements, such as remote sensing devices, digital photography, and multisensor devices, which have the potential to improve the assessment of dietary intake and physical activity in free-living adults. This review will provide researchers with emerging evidence in support of these technologies, as well as a quick reference for selecting the "right-sized" assessment method based on study design, target population, outcome variables of interest, and economic and time considerations. THEME INFORMATION: This article is part of a theme issue entitled Innovative Tools for Assessing Diet and Physical Activity for Health Promotion, which is sponsored by the North American branch of the International Life Sciences Institute.

Mobile Ecological Momentary Diet Assessment Methods for Behavioral Research: Systematic Review.

BACKGROUND: New methods for assessing diet in research are being developed to address the limitations of traditional dietary assessment methods. Mobile device-assisted ecological momentary diet assessment (mEMDA) is a new dietary assessment method that has not yet been optimized and has the potential to minimize recall biases and participant burden while maximizing ecological validity. There have been limited efforts to characterize the use of mEMDA in behavioral research settings. OBJECTIVE: The aims of this study were to summarize mEMDA protocols used in research to date, to characterize key aspects of these assessment approaches, and to discuss the advantages and disadvantages of mEMDA compared with the traditional dietary assessment methods as well as implications for future mEMDA research. METHODS: Studies that used mobile devices and described mEMDA protocols to assess dietary intake were included. Data were extracted according to Preferred Reporting of Systematic Reviews and Meta-Analyses and Cochrane guidelines and then synthesized narratively. RESULTS: The review included 20 studies with unique mEMDA protocols. Of these, 50% (10/20) used participant-initiated reports of intake at eating events (event-contingent mEMDA), and 50% (10/20) used researcher-initiated prompts requesting that participants report recent dietary intake (signal-contingent mEMDA). A majority of the study protocols (60%, 12/20) enabled participants to use mobile phones to report dietary data. Event-contingent mEMDA protocols most commonly assessed diet in real time, used dietary records for data collection (60%, 6/10), and provided estimates of energy and nutrient intake (60%, 6/10). All signal-contingent mEMDA protocols used a near real-time recall approach with unannounced (ie, random) abbreviated diet surveys. Most signal-contingent protocols (70%, 7/10) assessed the frequency with which (targeted) foods or food groups were consumed. Relatively few (30%, 6/20) studies compared mEMDA with the traditional dietary assessment methods. CONCLUSIONS: This review demonstrates that mEMDA has the potential to reduce participant burden and recall bias, thus advancing the field beyond current dietary assessment methods while maximizing ecological validity.

Evaluation of web-based, self-administered, graphical food frequency questionnaire.

Computer-administered food frequency questionnaires (FFQs) can address limitations inherent in paper questionnaires by allowing very complex skip patterns, portion size estimation based on food pictures, and real-time error checking. We evaluated a web-based FFQ, the Graphical Food Frequency System (GraFFS). Participants completed the GraFFS, six telephone-administered 24-hour dietary recalls over the next 12 weeks, followed by a second GraFFS. Participants were 40 men and 34 women, aged 18 to 69 years, living in the Columbus, OH, area. Intakes of energy, macronutrients, and 17 micronutrients/food components were estimated from the GraFFS and the mean of all recalls. Bias (second GraFFS minus recalls) was -9%, -5%, +4%, and -4% for energy and percentages of energy from fat, carbohydrate, and protein, respectively. De-attenuated, energy-adjusted correlations (intermethod reliability) between the recalls and the second GraFFS for fat, carbohydrate, protein, and alcohol were 0.82, 0.79, 0.67, and 0.90, respectively; for micronutrients/food components the median was 0.61 and ranged from 0.40 for zinc to 0.92 for beta carotene. The correlations between the two administrations of the GraFFS (test-retest reliability) for fat, carbohydrate, protein, and alcohol were 0.60, 0.63, 0.73, and 0.87, respectively; among micronutrients/food components the median was 0.67 and ranged from 0.49 for vitamin B-12 to 0.82 for fiber. The measurement characteristics of the GraFFS were at least as good as those reported for most paper FFQs, and its high intermethod reliability suggests that further development of computer-administered FFQs is warranted.