Trial · NCT07910617
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in overall dietary quality (Healthy Eating Index-2020) | Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period) | Dietary quality is measured with the Healthy Eating Index-2020 (HEI-2020), calculated from mean intake across two 24-hour dietary recalls administered at each timepoint by trained staff of the Johns Hopkins ICTR Nutrition Core. HEI-2020 is a composite measure of dietary quality scored from 0 to 100, based on 13 components: nine adequacy components (e.g., whole grains, total vegetables, seafood and plant proteins) and four moderation components (e.g., refined grains, sodium, added sugars). A higher score indicates better diet quality and closer alignment with the 2020-2025 Dietary Guidelines for Americans. |
| Secondary | Change in HEI-2020 sub-component scores (Adequacy and Moderation) | Baseline (Week 0) and endline (Week 8) | Adequacy scores range from 0-5 (total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood and plant proteins). Moderation scores range from 0-10 (whole grains, dairy, fatty acids, refined grains, sodium, added sugars, saturated fats). Higher scores indicate healthier intake (higher intake for adequacy components and lower intake for moderation components). |
| Secondary | Change in intake of total fruits (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total fruit (including 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of whole fruits (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total whole fruit (excluding 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of total vegetables (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total vegetable intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of greens and beans (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total intake of greens and beans in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of whole grains (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total whole grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of dairy (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total dairy intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of total protein foods (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total protein food (including legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of seafood and plant proteins (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total seafood and plant protein (including nuts, seeds, soy products, legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each time point. |
| Secondary | Change in intake of fatty acids (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Ratio of fatty acids (PUFA + MUFA)/ SFA, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of refined grains (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total refined grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of sodium (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total sodium intake in milligrams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of added sugar (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total added sugar intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in intake of saturated fat (HEI sub-component) | Baseline (Week 0) and endline (Week 8) | Total saturated fat intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in beef consumption | Baseline (Week 0) and endline (Week 8) | Beef consumption in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. A decrease indicates reduced beef consumption. |
| Secondary | Change in total energy intake | Baseline (Week 0) and endline (Week 8) | Total energy intake in kilocalories per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
| Secondary | Change in fiber intake | Baseline (Week 0) and endline (Week 8) | Fiber intake in grams per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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