- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04515303
Digital Intervention Participation in DASH
Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Nearly 50% of adults in the United States have high blood pressure, a leading contributor to cardiovascular disease. When race is considered, the majority of black adults (55%) have high blood pressure, a greater prevalence than other racial/ethnic groups. The elevated rate of high blood pressure, a diet-related disease, reflects the sub-optimal diet quality observed in blacks. The DASH dietary pattern is an evidence-based strategy to treat high blood pressure that has become part of the Dietary Guidelines for Americans. DASH promotes a diet rich in fruits and vegetables, low-fat dairy, controlled amounts of total fat, cholesterol and saturated fat, high fiber and protein content. Data from the National Health and Nutrition Examination Survey indicate that approximately 19% of adults with high blood pressure were DASH adherent. Those who were adherent tended to be older and non-black with a higher education level. Even after intervention, lower DASH adherence scores have been seen in blacks versus whites, possibly due to lower baseline consumption of DASH foods in blacks. Although dietary improvements from DASH-promoting interventions have been observed, adherence has decreased over time, and when translated to less controlled settings. Sufficient representation of blacks is important for clinical trials testing DASH given the disproportionate prevalence of high blood pressure. This study will examine factors that may influence black adults' participation and success in improving dietary quality through the following aims:
- To identify barriers to and facilitators of recruiting black adults into a digital DASH-promoting intervention. A semi-structured interview guide will direct individual interviews via phone with black men and women to understand what supports or deters participation in a digital health intervention trial for dietary quality improvement.
To determine the barriers and facilitators to improving dietary quality in black adults.
Participants in the individual interviews (Aim 1) will also identify their motivations, concerns and priorities surrounding dietary change. This will inform recruitment efforts and our understanding about how to improve dietary quality.
- To conduct secondary data analyses to determine the effectiveness, by race and gender group, of various recruitment methods from a 12-month randomized controlled trial to examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure (clinical trails identifier: NCT03875768). The intervention asks participants to track their diet daily using a common commercial tracking app with an extensive nutrient database via smartphone. Food and nutrient data from the app is processed using an application programming interface, compared against an algorithm, and generates personalized automated text messages to each participant with information on DASH diet adherence and diet tips. Responsive coaching is also included for participants that require greater support for dietary change.
Diverse sample recruitment is essential to producing outcomes that are applicable to diverse populations living with hypertension. Examination of barriers and facilitators to consuming a quality diet and identification of effective recruitment methods for digital interventions may inform how investigators reach black men and women with hypertension to effectively improve diet for the treatment of cardiovascular disease.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Loneke Blackman Carr, PhD, RD
- Numero di telefono: 860-486-5073
- Email: Loneke.blackman_carr@uconn.edu
Luoghi di studio
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Connecticut
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Storrs, Connecticut, Stati Uniti, 06103
- Reclutamento
- University of Connecticut
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Contatto:
- Loneke T. Blackman Carr, PhD, RD
- Numero di telefono: 860-486-5073
- Email: loneke.blackman_carr@uconn.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- self-identify as having high blood pressure
- self-identify as Black/African American/Afro-Caribbean
- at least 18 years old
- self-reported body mass index≥ 18.5 kg/m2
- email address
- English is primary language
Exclusion Criteria:
- planning to leave the area during study time period
- participating in a related trial
- cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- pregnancy - current or planned during the study period
- active malignancy
- recent psychiatric institutionalization
- documented dementia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Barriers and facilitators of recruitment
Lasso di tempo: day 1
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Using individual interviews to elicit information of potential recruitment preferences
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day 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Barriers and facilitators of diet quality
Lasso di tempo: day 1
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Individual interviews to understand black men/women's diet quality experiences
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day 1
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Comparison of recruitment methods
Lasso di tempo: Baseline
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Use recruitment data collected from the main trial to compare the most effective recruitment methods for black men and women
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Baseline
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Loneke Blackman Carr, PhD, RD, University of Connecticut
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KFS 5658780
- 3R01HL146768-01S1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Diverse Intervention Participation in DASH
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Shiraz University of Medical SciencesCompletato