Diet and Exercise for Underserved Women
18. april 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
180
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
South Carolina
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Columbia, South Carolina, Forente stater, 29208
- Prevention Research Center, University of South Carolina
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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
25 år til 50 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
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Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
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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
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Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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.
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one year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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.
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one year
|
|
fruit and vegetable intake
Tidsramme: one year
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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.
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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.
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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.
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one year
|
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physical activity level
Tidsramme: one year
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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.
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one year
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social support
Tidsramme: one year
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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.
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one year
|
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healthy eating behaviors
Tidsramme: one year
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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.
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one year
|
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exercise self-efficacy
Tidsramme: one year
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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.
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one year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patricia A Sharpe, PhD, MPH, University of South Carolina
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
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
1. august 2007
Primær fullføring (Faktiske)
1. november 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
28. juli 2010
Først innsendt som oppfylte QC-kriteriene
28. juli 2010
Først lagt ut (Anslag)
29. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Pro00003053
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