You need to sign in or sign up before continuing.
Back to History

Fields Changed

Registration

Field Before After
Last Published June 26, 2026 04:38 PM June 26, 2026 05:06 PM
Primary Outcomes (End Points) The primary outcome we are going to monitor is the difference between the HEI-2020 score at baseline (week 0) and week 12. HEI- 2020 measures the dietary quality compared with the key dietary recommendations and dietary patterns by the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher values indicating closer adherence to the guideline. We will also monitor the changes in different categories, such as changes in the fruit component and the vegetable component via the HEI-2020 Fruit sub-score and the HEI-2020 Vegetable sub-score. App engagement data and behavioral questions will serve as the explanatory variables in the study. The primary outcome we are going to monitor is the difference between the HEI-2020 score at baseline (week 0) and week 12 planned (7 weeks implemented). HEI- 2020 measures the dietary quality compared with the key dietary recommendations and dietary patterns by the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher values indicating closer adherence to the guideline. We will also monitor the changes in different categories, such as changes in the fruit component and the vegetable component via the HEI-2020 Fruit sub-score and the HEI-2020 Vegetable sub-score. App engagement data and behavioral questions will serve as the explanatory variables in the study.
Primary Outcomes (Explanation) Dietary Quality: Change in Healthy Eating Index-2020 (HEI-2020) score from baseline (Week 0) to end of intervention (Week 12), computed from two 24-hour dietary recalls delivered in Forthright using the USDA Automated Multiple-Pass Method (ASA24) . Adherence: Proportion of AI-recommended meals actually consumed over the 12-week period, as recorded in the FRS app’s daily meal-tracking logs. Dietary Quality: Change in Healthy Eating Index-2020 (HEI-2020) score from baseline (Week 0) to end of intervention (Week 12 planned and 7 weeks implemented), computed from two 24-hour dietary recalls delivered in Forthright using the USDA Automated Multiple-Pass Method (ASA24). Adherence: Proportion of AI-recommended meals actually consumed over the trial period, as recorded in the FRS app’s daily meal-tracking logs.
Experimental Design (Public) We will screen approximately 1,900 U.S. adults through the Forthright Access platform. After an eligibility screener (≥ 18 years; basic English; regular smartphone and internet access; generally healthy adults for whom the Dietary Guidelines for Americans are appropriate — excluding those requiring medically supervised or restrictive diets, e.g., diabetes, celiac/gluten sensitivity, CKD requiring dietary restriction, prescribed or highly restrictive diets, or pregnancy), Forthright's server-side block randomizer will assign eligible participants 1:1 to two parallel arms. Accounting for ≈50% eligibility and ≈10% attrition, we anticipate an analytic sample of ≈780 (≈390 per arm). Both arms use the same mobile/web application, which includes a Track Mode for all participants (log meals; view nutrient and diet-quality summaries) and a Personalized Recommendation Mode for the treatment arm only. Treatment arm – the app with Track Mode plus the AI/NLP-driven Personalized Recommendation Mode (OpenAI engine constrained to USDA FPED, the Dietary Guidelines, and AMDR ranges; educational only). Control arm – the same app shell in Track Mode only (tracking + general, non-personalized guidance); no AI-personalized recommendations. Single-blind from the participant's side; participants are told only that they will receive "nutrition guidance"; the control arm is not informed another group receives AI recommendations. Forthright/the technology team handle randomization; the data-analysis team is masked to arm codes. Dietary intake and behavioral questions are collected at baseline (Week 0) and at the post-intervention endline [registered Week 12; implemented after ~7 weeks under the approved modification]. Intake is measured with ASA24; treatment participants are asked to use the app ≥ once/week and to indicate whether they followed each recommendation; app analytics are logged automatically for engagement/uptake analyses. We will screen approximately 1,900 U.S. adults through the Forthright Access platform. After an eligibility screener (≥ 18 years; basic English; regular smartphone and internet access; generally healthy adults for whom the Dietary Guidelines for Americans are appropriate — excluding those requiring medically supervised or restrictive diets, e.g., diabetes, celiac/gluten sensitivity, CKD requiring dietary restriction, prescribed or highly restrictive diets, or pregnancy), the research team randomly assigned eligible participants 1:1 to two parallel arms. Accounting for ≈50% eligibility and ≈10% attrition, we anticipate an analytic sample of ≈780 (≈390 per arm). Both arms use the same mobile/web application, which includes a Track Mode for all participants (log meals; view nutrient and diet-quality summaries) and a Personalized Recommendation Mode for the treatment arm only. Treatment arm – the app with Track Mode plus the AI/NLP-driven Personalized Recommendation Mode (OpenAI engine constrained to USDA FPED, the Dietary Guidelines, and AMDR ranges; educational only). Control arm – the same app shell in Track Mode only (tracking + general, non-personalized guidance); no AI-personalized recommendations. Single-blind from the participant's side; participants are told only that they will receive "nutrition guidance"; the control arm is not informed another group receives AI recommendations. Forthright/the technology team handle randomization; the data-analysis team is masked to arm codes. Dietary intake and behavioral questions are collected at baseline (Week 0) and at the post-intervention endline [registered Week 12; implemented after ~7 weeks under the approved modification]. Intake is measured with ASA24; treatment participants are asked to use the app ≥ once/week and to indicate whether they followed each recommendation; app analytics are logged automatically for engagement/uptake analyses.
Planned Number of Observations 700 U.S. adults per arm (1,400 U.S. adults in total ) through the Forthright platform. ≈780 analytic (≈390 per arm); ≈1,900 screened / ≈950 randomized planned
Back to top