Daily Dietary Sodium Intake among Clinical Trial Participants Recruited from a University Health System or a Federally Qualified Health Center: A prospective, randomized-controlled, remotely administered trial (Preprint) Article Swipe
Gabriella VanAken
,
Michael P. Dorsch
,
Scott L. Hummel
,
Tanima Basu
,
Evan Luff
,
Kimberly Warden
,
Michael Giacalone
,
Sarah Bailey
,
Mark Newman
,
Lesli E. Skolarus
,
Brahmajee K. Nallamothu
,
Jessica R. Golbus
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.2196/preprints.71343
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.2196/preprints.71343
BACKGROUND Clinical trials increasingly focus on diverse recruitment based on demographic factors and health-related social needs. OBJECTIVE We sought to understand the impact of demographic factors and health-related social needs on dietary sodium intake in a contemporary trial. METHODS The myBPmyLife study is a prospective, randomized-controlled trial designed to evaluate a mobile health (mHealth) intervention to lower blood pressure through increased physical activity and lower sodium food choices. Hypertensive participants recruited from a university health system and federally qualified health center (FQHC) completed a baseline sodium screener. Univariable and multivariable models evaluated the association between sodium intake at baseline–a key inclusion criterion–and participant characteristics. RESULTS Of the 600 included participants, 96 (16.0%) were from the FQHC. Mean age was 60.1 (SD 13.5) years; 48.2% were women, and 13.0% were Black. Notable differences were seen between sites: FQHC participants were, on average, 14.6 years younger than university participants, more likely to be Black (44.8% versus 6.9%), and 8.5 times more likely to have difficulty paying for their health-related social needs. Sodium intake at baseline was significantly higher for FQHC participants (mean difference 381.1 mg/day; 95% CI 84.5 to 677.7; P=.012). Adjustments for demographic characteristics and health-related social needs mitigated differences in sodium intake between sites. CONCLUSIONS In this clinical trial of an mHealth intervention, we found important participant differences in demographics and health-related social need-related factors based on the site of enrollment. As clinical trials recruit for diversity based on demographic characteristics, they may also benefit from diversifying enrollment sites to ensure truly representative populations. CLINICALTRIAL URL: https://www.clinicaltrials.gov; Unique identifier: NCT05154929.
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- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.2196/preprints.71343
- OA Status
- gold
- References
- 20
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4406605896
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Raw OpenAlex JSON
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https://openalex.org/W4406605896Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.2196/preprints.71343Digital Object Identifier
- Title
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Daily Dietary Sodium Intake among Clinical Trial Participants Recruited from a University Health System or a Federally Qualified Health Center: A prospective, randomized-controlled, remotely administered trial (Preprint)Work title
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preprintOpenAlex work type
- Language
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enPrimary language
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2025Year of publication
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2025-01-15Full publication date if available
- Authors
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Gabriella VanAken, Michael P. Dorsch, Scott L. Hummel, Tanima Basu, Evan Luff, Kimberly Warden, Michael Giacalone, Sarah Bailey, Mark Newman, Lesli E. Skolarus, Brahmajee K. Nallamothu, Jessica R. GolbusList of authors in order
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https://doi.org/10.2196/preprints.71343Publisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.2196/preprints.71343Direct OA link when available
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Preprint, Center (category theory), Medicine, Randomized controlled trial, Gerontology, Clinical trial, Physical therapy, Family medicine, Environmental health, Internal medicine, Computer science, Crystallography, Chemistry, World Wide WebTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.sodium | 35, 70, 90, 100, 207 |
| abstract_inverted_index.sought | 21 |
| abstract_inverted_index.system | 80 |
| abstract_inverted_index.trial. | 40 |
| abstract_inverted_index.trials | 3, 242 |
| abstract_inverted_index.versus | 160 |
| abstract_inverted_index.women, | 132 |
| abstract_inverted_index.years; | 129 |
| abstract_inverted_index.(16.0%) | 118 |
| abstract_inverted_index.Notable | 137 |
| abstract_inverted_index.benefit | 253 |
| abstract_inverted_index.between | 99, 141, 209 |
| abstract_inverted_index.dietary | 34 |
| abstract_inverted_index.diverse | 7 |
| abstract_inverted_index.factors | 12, 28, 233 |
| abstract_inverted_index.mHealth | 220 |
| abstract_inverted_index.mg/day; | 189 |
| abstract_inverted_index.recruit | 243 |
| abstract_inverted_index.through | 64 |
| abstract_inverted_index.younger | 150 |
| abstract_inverted_index.Clinical | 2 |
| abstract_inverted_index.P=.012). | 195 |
| abstract_inverted_index.activity | 67 |
| abstract_inverted_index.average, | 147 |
| abstract_inverted_index.baseline | 89, 179 |
| abstract_inverted_index.choices. | 72 |
| abstract_inverted_index.clinical | 216, 241 |
| abstract_inverted_index.designed | 52 |
| abstract_inverted_index.evaluate | 54 |
| abstract_inverted_index.included | 115 |
| abstract_inverted_index.physical | 66 |
| abstract_inverted_index.pressure | 63 |
| abstract_inverted_index.(mHealth) | 58 |
| abstract_inverted_index.completed | 87 |
| abstract_inverted_index.diversity | 245 |
| abstract_inverted_index.evaluated | 96 |
| abstract_inverted_index.federally | 82 |
| abstract_inverted_index.important | 224 |
| abstract_inverted_index.inclusion | 105 |
| abstract_inverted_index.increased | 65 |
| abstract_inverted_index.mitigated | 204 |
| abstract_inverted_index.qualified | 83 |
| abstract_inverted_index.recruited | 75 |
| abstract_inverted_index.screener. | 91 |
| abstract_inverted_index.difference | 187 |
| abstract_inverted_index.difficulty | 169 |
| abstract_inverted_index.enrollment | 256 |
| abstract_inverted_index.myBPmyLife | 45 |
| abstract_inverted_index.understand | 23 |
| abstract_inverted_index.university | 78, 152 |
| abstract_inverted_index.Adjustments | 196 |
| abstract_inverted_index.Univariable | 92 |
| abstract_inverted_index.association | 98 |
| abstract_inverted_index.demographic | 11, 27, 198, 248 |
| abstract_inverted_index.differences | 138, 205, 226 |
| abstract_inverted_index.enrollment. | 239 |
| abstract_inverted_index.identifier: | 269 |
| abstract_inverted_index.participant | 107, 225 |
| abstract_inverted_index.recruitment | 8 |
| abstract_inverted_index.Hypertensive | 73 |
| abstract_inverted_index.NCT05154929. | 270 |
| abstract_inverted_index.baseline–a | 103 |
| abstract_inverted_index.contemporary | 39 |
| abstract_inverted_index.demographics | 228 |
| abstract_inverted_index.diversifying | 255 |
| abstract_inverted_index.increasingly | 4 |
| abstract_inverted_index.intervention | 59 |
| abstract_inverted_index.need-related | 232 |
| abstract_inverted_index.participants | 74, 144, 185 |
| abstract_inverted_index.populations. | 262 |
| abstract_inverted_index.prospective, | 49 |
| abstract_inverted_index.intervention, | 221 |
| abstract_inverted_index.multivariable | 94 |
| abstract_inverted_index.participants, | 116, 153 |
| abstract_inverted_index.significantly | 181 |
| abstract_inverted_index.health-related | 14, 30, 173, 201, 230 |
| abstract_inverted_index.representative | 261 |
| abstract_inverted_index.characteristics | 199 |
| abstract_inverted_index.criterion–and | 106 |
| abstract_inverted_index.characteristics, | 249 |
| abstract_inverted_index.characteristics. | 108 |
| abstract_inverted_index.randomized-controlled | 50 |
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| abstract_inverted_index.<title>RESULTS</title> | 111 |
| abstract_inverted_index.<title>OBJECTIVE</title> | 19 |
| abstract_inverted_index.<title>BACKGROUND</title> | 1 |
| abstract_inverted_index.<title>CONCLUSIONS</title> | 213 |
| abstract_inverted_index.<title>CLINICALTRIAL</title> | 265 |
| abstract_inverted_index.https://www.clinicaltrials.gov; | 267 |
| cited_by_percentile_year | |
| countries_distinct_count | 0 |
| institutions_distinct_count | 12 |
| citation_normalized_percentile.value | 0.01814851 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |