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Diet and Exercise for Underserved Women

18. april 2019 opdateret af: Patricia Sharpe, University of South Carolina

Behavioral/Support Intervention for Diet and Exercise Among Underserved Women

The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

180

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
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29208
        • Prevention Research Center, University of South Carolina

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

25 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 25-50 years of age
  • live in Census tracts with 25% or more below poverty in Columbia, SC
  • waist circumference >88 cm

Exclusion Criteria:

  • insulin-dependent
  • pregnant
  • moderate exercise contraindicated
  • not in control of food choices [institutional setting or restricted diet]
  • uncontrolled hypertension
  • weight >430 pounds

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: Behavioral and support intervention
one individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup
Adfærdsmæssigt: Behavioral and support intervention
Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
Placebo komparator: wait-listed control group
Controls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention
Adfærdsmæssigt: Wait-listed control group
Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
body weight
Tidsramme: one year
body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
waist circumference
Tidsramme: one year
waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
dietary fat intake
Tidsramme: one year
total dietary fat intake in grams and % of energy intake is assessed via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
saturated dietary fat intake
Tidsramme: one year
Saturated fat intake in grams and % of energy intake is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
fruit and vegetable intake
Tidsramme: one year
Average daily servings of fruit and vegetables is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
dietary fiber intake
Tidsramme: one year
Average daily intake of dietary fiber in grams is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
total energy intake
Tidsramme: one year
Total energy intake in kcals is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
physical activity level
Tidsramme: one year
Time spent in light, moderate and vigorous physical activity is estimated from 7 days of accelerometer wear at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
social support
Tidsramme: one year
Social support for healthy eating and exercise is measure via interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
healthy eating behaviors
Tidsramme: one year
Healthy eating behaviors are measured with a validated scaled via interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year
exercise self-efficacy
Tidsramme: one year
Exercise self-efficacy is measured via a validated scale by interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
one year

Samarbejdspartnere og efterforskere

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

Sponsor

University of South Carolina

Efterforskere

  • Ledende efterforsker: Patricia A Sharpe, PhD, MPH, University of South Carolina

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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

1. august 2007

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

28. juli 2010

Først indsendt, der opfyldte QC-kriterier

28. juli 2010

Først opslået (Skøn)

29. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Pro00003053

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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