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

17 april 2017 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

84

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in Weight
Tidsram: Baseline to 6 months
Baseline to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2016

Primärt slutförande (Faktisk)

1 mars 2017

Avslutad studie (Faktisk)

1 mars 2017

Studieregistreringsdatum

Först inskickad

11 december 2015

Först inskickad som uppfyllde QC-kriterierna

11 december 2015

Första postat (Uppskatta)

15 december 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 15-0484

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