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An Exercise Intervention to Prevent Gestational Diabetes

24. oktober 2016 oppdatert av: Lisa Chasan-Taber, University of Massachusetts, Amherst

An Exercise Intervention to Prevent Recurrent GDM

Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. It is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent studies have suggested that women with higher levels of physical activity have reduced risk of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing GDM among women with a history of GDM.

Studieoversikt

Detaljert beskrivelse

The primary goals of the application are to investigate the effects of a motivationally-tailored, individually targeted 12-wk physical activity intervention on 1) risk of GDM in women at high risk of the condition, 2) serum biomarkers associated with insulin resistance, 3) and the adoption and maintenance of exercise during pregnancy. Secondary goals are to investigate the impact of the intervention on gestational weight gain and selected birth outcomes. The overall goal of the intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists (ACOG) Guidelines for physical activity during pregnancy (30 minutes or more of moderate- intensity activity on most days of the week) through increasing walking and developing a more active lifestyle. The intervention draws from the theory of Stages of Motivational Readiness for Change and Social Cognitive Theory constructs for physical activity behavior and will take into account the specific social, cultural, economic, and physical environmental challenges faced by women of diverse socioeconomic and ethnic backgrounds. The application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent GDM among high risk women. The intervention protocol can readily be translated into clinical practice in underserved and minority populations.

Studietype

Intervensjonell

Registrering (Faktiske)

488

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Springfield, Massachusetts, Forente stater, 01199
        • Batstate Medical Center

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 til 40 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • history of gestational diabetes or overweight (>25 kg/m2) with family history of type 2 diabetes
  • sedentary

Exclusion Criteria:

  • history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
  • current medications which adversely influence glucose tolerance
  • not planning to continue the pregnancy to term
  • >16 weeks gestation
  • contraindications to participating in moderate physical activity
  • inability to read English at a 6th grade level
  • self-reported participation in >30 min of moderate or vigorous-intensity exercise on >3 days/wk
  • prior participation in the study
  • non-singleton pregnancy

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Trening
Individually Tailored (IT) Exercise Intervention This intervention is designed to increase the amount of physical activity incorporated into the daily lifestyle of pregnant women, primarily through increased walking, with the ultimate goal of achieving the American College of Obstetricians and Gynecologists (ACOG) exercise goals for pregnant women. These goals are the same as the Surgeon General's Guidelines for physical activity for nonpregnant individuals (30 minutes or more or moderate activity on most days of the week).The intervention includes: 1) individually tailored print-based materials (i.e., individually-tailored reports and stage-matched manuals), 2) self-monitoring materials, and 3) goal setting.
Aktiv komparator: Heath & Wellness
The comparison intervention consists of a series of informational booklets published by the American College of Obstetricians and Gynecologists on general issues related to health and wellness during pregnancy. These include alcohol and drug use during pregnancy, easing back pain, as well as the Pregnancy Fitness brochure on the safety of exercise during pregnancy. These booklets are selected to represent high-quality, standard, low-cost, self-help material currently available to the public.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Gestational diabetes diagnosis assessed through glucose tolerance test.
Tidsramme: 28 weeks gestational age
28 weeks gestational age

Sekundære resultatmål

Resultatmål
Tidsramme
Maternal weight gain
Tidsramme: 40 weeks gestational age
40 weeks gestational age
Glucose
Tidsramme: 28 weeks gestational age
28 weeks gestational age
Insulin
Tidsramme: 28 weeks gestational age
28 weeks gestational age
Adiponectin
Tidsramme: 28 weeks gestational age
28 weeks gestational age
Resistin
Tidsramme: 28 weeks gestational age
28 weeks gestational age
TNF-alpha
Tidsramme: 28 weeks gestational age
28 weeks gestational age
CRP
Tidsramme: 28 weeks gestational age
28 weeks gestational age
Birth weight
Tidsramme: 40 weeks gestational age
40 weeks gestational age
Apgar score
Tidsramme: 40 weeks gestational age
40 weeks gestational age
Adoption and maintenance of exercise during pregnancy
Tidsramme: 40 weeks gestational age
40 weeks gestational age

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Lisa Chasan-Taber, University of Massachusetts, Amherst

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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. juli 2007

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

2. august 2008

Først innsendt som oppfylte QC-kriteriene

2. august 2008

Først lagt ut (Anslag)

5. august 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • DK74876
  • R01DK074876 (U.S. NIH-stipend/kontrakt)
  • 1R01DK074876-01A1 (U.S. NIH-stipend/kontrakt)

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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