Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: A Sequential Explanatory Mixed Methods Investigation.

BACKGROUND: Nutrigenomics forms the basis of personalized nutrition by customizing an individual's dietary plan based on the integration of life stage, current health status, and genome information. Some common genes that are included in nutrition-based multigene test panels include CYP1A2 (rate of caffeine break down), MTHFR (folate usage), NOS3 (risk of elevated triglyceride levels related to omega-3 fat intake), and ACE (blood pressure response in related to sodium intake). The complexity of gene test-based personalized nutrition presents barriers to its implementation. OBJECTIVE: This study aimed to compare a self-driven approach to gene test-based nutrition education versus an integrated practitioner-facilitated method to help develop improved interface tools for personalized nutrition practice. METHODS: A sequential, explanatory mixed methods investigation of 55 healthy adults (35 to 55 years) was conducted that included (1) a 9-week randomized controlled trial where participants were randomized to receive a standard nutrition-based gene test report (control; n=19) or a practitioner-facilitated personalized nutrition intervention (intervention; n=36) and (2) an interpretative thematic analysis of focus group interview data. Outcome measures included differences in the diet quality score (Healthy Eating Index-Canadian [HEI-C]; proportion [%] of calories from total fat, saturated fat, and sugar; omega 3 fatty acid intake [grams]; sodium intake [milligrams]); as well as health-related quality of life (HRQoL) scale score. RESULTS: Of the 55 (55/58 enrolled, 95%) participants who completed the study, most were aged between 40 and 51 years (n=37, 67%), were female (n=41, 75%), and earned a high household income (n=32, 58%). Compared with baseline measures, group differences were found for the percentage of calories from total fat (mean difference [MD]=-5.1%; Wilks lambda (λ)=0.817, F1,53=11.68; P=.001; eta-squared [η²]=0.183) and saturated fat (MD=-1.7%; λ=0.816; F1,53=11.71; P=.001; η²=0.18) as well as HRQoL scores (MD=8.1 points; λ=0.914; F1,53=4.92; P=.03; η²=0.086) compared with week 9 postintervention measures. Interactions of time-by-group assignment were found for sodium intakes (λ=0.846; F1,53=9.47; P=.003; η²=0.15) and HEI-C scores (λ=0.660; F1,53=27.43; P<.001; η²=0.35). An analysis of phenotypic and genotypic information by group assignment found improved total fat (MD=-5%; λ=0.815; F1,51=11.36; P=.001; η²=0.19) and saturated fat (MD=-1.3%; λ=0.822; F1,51=10.86; P=.002; η²=0.18) intakes. Time-by-group interactions were found for sodium (λ=0.844; F3,51=3.09; P=.04; η²=0.16); a post hoc analysis showed pre/post differences for those in the intervention group that did (preintervention mean 3611 mg, 95% CI 3039-4182; postintervention mean 2135 mg, 95% CI 1564-2705) and did not have the gene risk variant (preintervention mean 3722 mg, 95% CI 2949-4496; postintervention mean 2071 mg, 95% CI 1299-2843). Pre- and postdifferences related to the Dietary Reference Intakes showed increases in the proportion of intervention participants within the acceptable macronutrient distribution ranges for fat (pre/post mean difference=41.2%; P=.02). Analysis of textual data revealed 3 categories of feedback: (1) translation of nutrition-related gene test information to action; (2) facilitation of eating behavior change, particularly for the macronutrients and sodium; and (3) directives for future personalized nutrition practice. CONCLUSIONS: Although improvements were observed in both groups, healthy adults appear to derive more health benefits from practitioner-led personalized nutrition interventions. Further work is needed to better facilitate positive changes in micronutrient intakes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.9846.

Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: Protocol for a Mixed-Methods Study.

BACKGROUND: Although nutrition interventions are a widely accepted resource for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential; however, it is complicated to implement. There is a need for products based on nutrition-related gene test results that are easily understood, accessible, and used. OBJECTIVE: The primary objective of this study was to compare a nonpractitioner-assisted direct-to-consumer self-driven approach to nutrigenomics versus an integrated and personalized practitioner-led method. METHODS: This 4-month study used a mixed-methods design that included (1) a phase 1 randomized controlled trial that examined the effectiveness of a multifaceted, nutrition-based gene test (components assessed included major nutrients, food tolerances, food taste and preferences, and micronutrients) in changing health behaviors, followed by (2) a qualitative investigation that explored participants' experiences. The study recruited 55 healthy males and females (aged 35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene test results plus integrated and personalized nutrition report) and 19 were assigned to the control group (gene test results report emailed). The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), changes in measures on General Self-efficacy and Health-Related Quality of Life scales, and anthropometrics (body mass index, waist-to-hip ratio) measured at baseline, post intervention (3 and 6 weeks), and the final visit (week 9 post intervention). RESULTS: Of the 478 individuals who expressed interest, 180 were invited (37.7%, 180/478) and completed the eligibility screening questionnaire; 73 of the 180 invited individuals (40.5%) were deemed eligible. Of the 73 individuals who were deemed to be eligible, 58 completed the baseline health questionnaire and food records (79%). Of these 58 individuals, 3 were excluded either because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). CONCLUSIONS: This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate show that there is a great degree of interest in this field. Given this interest and the fact that nutrigenomics is an evolving science, a need for continued research exists to further the understanding of the role of genetic variation and its role and applications in nutrition practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814 (Archived by WebCite at http://www.webcitation.org/6yGnU5deB). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9846.