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Digital Intervention Participation in DASH

23. april 2021 oppdatert av: Loneke T. Blackman Carr, PhD, RD, University of Connecticut

Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension

This study will examine the context of making high quality dietary choices among Black adults with hypertension. Secondly, this study will also investigate what Black adults need or desire to participate in a digital intervention to improve dietary quality by adopting the DASH eating pattern.

Studieoversikt

Detaljert beskrivelse

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:

  1. 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.
  2. 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.

  3. 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Connecticut
      • Storrs, Connecticut, Forente stater, 06103
        • Rekruttering
        • University of Connecticut
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Community sample

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Barriers and facilitators of recruitment
Tidsramme: day 1
Using individual interviews to elicit information of potential recruitment preferences
day 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Barriers and facilitators of diet quality
Tidsramme: day 1
Individual interviews to understand black men/women's diet quality experiences
day 1
Comparison of recruitment methods
Tidsramme: Baseline
Use recruitment data collected from the main trial to compare the most effective recruitment methods for black men and women
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Loneke Blackman Carr, PhD, RD, University of Connecticut

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. september 2020

Primær fullføring (Forventet)

31. mars 2023

Studiet fullført (Forventet)

31. mars 2023

Datoer for studieregistrering

Først innsendt

12. august 2020

Først innsendt som oppfylte QC-kriteriene

12. august 2020

Først lagt ut (Faktiske)

17. august 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KFS 5658780
  • 3R01HL146768-01S1 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

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NEI

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