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Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial (WIP)

17. november 2008 opdateret af: Carolinas Medical Center
The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. Unfortunately, the prevalence of excessive gestational weight gain is increasing. Gestational weight gain greater than that recommended by the Institute of Medicine (IOM) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. Currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. We hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the IOM recommendations.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center

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

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Establish prenatal care at 6 - 16 weeks gestation
  2. 18-49 years of age
  3. Receive their entire prenatal care at the Resident Obstetrics Clinic
  4. English and/or Spanish speaking
  5. Singleton gestation.

Exclusion Criteria:

  1. Establish prenatal care >16 weeks gestation
  2. Non-English or non-Spanish speaking
  3. Multiple gestation pregnancy
  4. BMI > 40
  5. Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
  6. Delivery at institution other than CMC-Main
  7. Pregnancy ending in a premature delivery (< 37 weeks)
  8. Limited prenatal care (<4 visits)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intensive Counseling Group
Adfærdsmæssigt: Dietary and lifestyle counseling

The intervention group will undergo a complete history and physical with attention to prepregnancy weight, current weight, height, and BMI. At the initial visit, they will meet with a registered dietician to receive a standardized counseling session, including information on pregnancy-specific dietary and lifestyle choices. The patient will be instructed to engage in moderate intensity exercise at least 3 times per week and preferably 5 times per week. They will also receive information on the appropriate weight gain during pregnancy using the IOM guidelines. Each subject will meet with the dietician only at the time of enrollment.

At each routine obstetric appointment, the participant's weight will be measured and charted on an IOM Gestational Weight Gain Grid in front of the participant. The healthcare provider will inform the participant if her weight gain was at the appropriate level and counsel her accordingly regarding increasing or decreasing her intake and exercise.
Ingen indgriben: Routine care group
The routine care group took part in an initial physical exam and history, routine labs, and routine visits per American College of Obstetrics & Gynecology (ACOG) standards. The only counseling on diet and exercise during pregnancy was that included in our standard prenatal booklet "What to do When You're Having a Baby" by Gloria Mayer (Institute for Health Advancement, 2003, La Habra, CA). At each routine obstetric appointment, the participant's weight was measured recorded in the medical chart. The healthcare provider did not counsel the participant regarding any changes in diet or lifestyle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
Tidsramme: 3 - 6 months
3 - 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.
Tidsramme: 3 - 6 months
3 - 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Carolinas Medical Center

Efterforskere

  • Ledende efterforsker: Shelly M Asbee, M.D., Lake Norman Ob/Gyn

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. oktober 2005

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

14. november 2008

Først indsendt, der opfyldte QC-kriterier

17. november 2008

Først opslået (Skøn)

18. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. november 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2008

Sidst verificeret

1. november 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WIP 06-05-04A

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 .

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