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Reducing Obesity in Underserved Postpartum African American Women (RENEW)

27. juni 2017 oppdatert av: Caroline Apovian, Boston Medical Center
In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity.

Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.

Studietype

Intervensjonell

Registrering (Faktiske)

128

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Pre-Natal:

    1. BMI greater than or equal to 25
    2. Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
    3. English-speaking

  • Post-partum:

    1. Live birth (based on medical record review)

Exclusion Criteria:

  • Pre-Natal:

    1. Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
    2. Previous enrollment in the Birth Sister's program prior to the study

  • Post-partum:

    1. Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
Weekly, in-person, support groups providing nutrition and physical activity education
Atferdsmessig: Nutrition and physical activity education
Eight weekly in-person groups
Ingen inngripen: Control
Standard of care - one counseling visit with a study dietitian

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Tidsramme: Weekly up to 8 weeks
Weekly up to 8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline Weight to 8 Weeks
Tidsramme: Baseline and 8 weeks
Baseline and 8 weeks
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Tidsramme: 8 weeks
8 weeks
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Tidsramme: Baseline and 8 weeks
Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
Baseline and 8 weeks
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Tidsramme: Baseline and 8 weeks
The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.
Baseline and 8 weeks
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Tidsramme: Baseline and 8 weeks
Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).
Baseline and 8 weeks
Waist Circumference at 8 Weeks
Tidsramme: 8 weeks
8 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Boston Medical Center

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Etterforskere

  • Hovedetterforsker: Caroline M. Apovian, MD, Professor of Medicine and Pediatrics

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 2011

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. september 2013

Datoer for studieregistrering

Først innsendt

12. mai 2015

Først innsendt som oppfylte QC-kriteriene

15. mai 2015

Først lagt ut (Anslag)

19. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-28272
  • R21HD061311 (U.S. NIH-stipend/kontrakt)
  • U54TR001012 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på Nutrition and physical activity education

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Forhold

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