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

17. april 2017 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Ikke anvendelig

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

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

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

Efterforskere

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

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)

1. marts 2016

Primær færdiggørelse (Faktiske)

1. marts 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

11. december 2015

Først indsendt, der opfyldte QC-kriterier

11. december 2015

Først opslået (Skøn)

15. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-0484

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 .

Kliniske forsøg med Physical Activity Enhanced Weight Loss Intervention

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