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Behavioral CVD Prevention Using Informatics

29. juni 2018 opdateret af: Lisa M. Quintiliani, Boston Medical Center

Behavioral Cardiovascular Disease Prevention Using Informatics

Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

105

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Willing to wear an accelerometer
  • 18-65 years old
  • Public housing resident with no plans to move in next 6 months
  • Body mass index ≥25
  • Open to making changes to diet & physical activity habits

Exclusion Criteria:

  • Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss
  • Primary language spoken is a language other than Spanish or English
  • Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Feedback report plus peer counseling
Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report
Adfærdsmæssigt: Counseling
Up to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions.
Adfærdsmæssigt: feedback report
All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
Aktiv komparator: Feedback report
Feedback report Participants receive a brief printed feedback report
Adfærdsmæssigt: feedback report
All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight-objective measurement
Tidsramme: 12 weeks
Weight in pounds will be measured objectively with a digital scale
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diet, fruits and vegetables, self-reported via questionnaire
Tidsramme: 12 weeks
Servings of fruits and vegetables will be measured via the Primescreen dietary screener instrument
12 weeks
Diet, sugar sweetened beverages, self-reported via questionnaire
Tidsramme: 12 weeks
Fluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire
12 weeks
Diet, fast food, self-reported via questionnaire
Tidsramme: 12 weeks
Number of visits to fast food restaurants will be measured via a 1-item question asking participants how often they go to fast food restaurants
12 weeks
Physical activity, objectively measured
Tidsramme: 12 weeks
Minutes of light to moderate physical activity will be measured via accelerometers (Actigraphs)
12 weeks
Physical activity, self-reported
Tidsramme: 12 weeks
Minutes of light to moderate physical activity will be measured via a questionnaire (IPAQ)
12 weeks
Internal motivation, self-reported via questionnaire
Tidsramme: 12 weeks
Perceptions of internal motivation to change diet and physical activity will be measured by a brief questionnaire
12 weeks
Self-efficacy for eating a healthful diet, self-reported via questionnaire
Tidsramme: 12 weeks
Perceptions of self-efficacy (or confidence) to change diet behaviors in a variety of situations will be measured by a brief questionnaire
12 weeks
Self-efficacy for doing physical activity, self-reported via questionnaire
Tidsramme: 12 weeks
Perceptions of self-efficacy (or confidence) to change physical activity behaviors in a variety of situations will be measured by a brief questionnaire
12 weeks
Social support, self-reported via questionnaire
Tidsramme: 12 weeks
Perceptions of social support from a variety of sources will be measured via a brief questionnaire
12 weeks
Feasibility, number of counseling sessions completed
Tidsramme: 12 weeks
Number of counseling sessions completed in-person and over the phone will be tallied and reported
12 weeks
Feasibility, acceptability of intervention
Tidsramme: 12 weeks
Perceptions of acceptability of both the brief feedback report and the counseling sessions will be asked in open- and closed-ended questions
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Medical Center

Samarbejdspartnere

American Heart Association

Efterforskere

  • Ledende efterforsker: Lisa M Quintiliani, PhD, Boston Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. september 2016

Primær færdiggørelse (Faktiske)

1. juni 2018

Studieafslutning (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først indsendt

19. april 2016

Først indsendt, der opfyldte QC-kriterier

23. april 2016

Først opslået (Skøn)

27. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • H-34964
  • 14SDG20050015 (Andet bevillings-/finansieringsnummer: American Heart Association)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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