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Sisters in Health: A Weight Loss Study for African American Women

17. april 2017 oppdatert av: Loneke T. Blackman Carr, University of North Carolina, Chapel Hill
The purpose of this study is to compare the effect of a physical activity-enhanced behavioral weight loss intervention, compared to a standard behavioral weight loss intervention in African American women.

Studieoversikt

Detaljert beskrivelse

A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases.

Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions.

The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Ikke aktuelt

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

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • 21-65 years old
  • Ability to read, write, and speak English

    • Female gender
    • African American/Black/African/Afro-Caribbean race (self-identified)
    • BMI 25-45 (> 45 may have greater risks while participating)
    • Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X
    • Willingness to be randomized
    • Willingness to participate for 6 months, including attending face-to-face sessions & outside of session tasks
    • Access to a computer reliable internet access
    • Willingness to use an app for diet and physical activity monitoring
    • Regularly used email address
    • Not planning to relocate
    • Able to attend group sessions on scheduled day

Exclusion Criteria:

  • Recently lost weight, 5-10% in last 6 months
  • Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
  • Pregnant or planning to become pregnant
  • Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
  • Type 2 diabetes being treated with insulin
  • Major psychological disorder
  • History of diagnosed eating disorder
  • Medications that affect weight (determined by study staff)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Physical Activity Enhanced Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component.
18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
Aktiv komparator: Standard Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
18 session, group-based, 6-month, standard behavioral weight loss intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in Weight
Tidsramme: Baseline to 6 months
Baseline to 6 months

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studiestol: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill
  • Hovedetterforsker: Loneke T. Blackman Carr, MA, RD, University of North Carolina, Chapel Hill

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)

1. mars 2016

Primær fullføring (Faktiske)

1. mars 2017

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

11. desember 2015

Først innsendt som oppfylte QC-kriteriene

11. desember 2015

Først lagt ut (Anslag)

15. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15-0484

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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