- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00728377
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
Status
Fullført
Forhold
Intervensjon / Behandling
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
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Massachusetts
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Springfield, Massachusetts, Forente stater, 01199
- Batstate Medical Center
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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.
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Aktiv komparator: Heath & Wellness
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Gestational diabetes diagnosis assessed through glucose tolerance test.
Tidsramme: 28 weeks gestational age
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28 weeks gestational age
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maternal weight gain
Tidsramme: 40 weeks gestational age
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40 weeks gestational age
|
Glucose
Tidsramme: 28 weeks gestational age
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28 weeks gestational age
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Insulin
Tidsramme: 28 weeks gestational age
|
28 weeks gestational age
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Adiponectin
Tidsramme: 28 weeks gestational age
|
28 weeks gestational age
|
Resistin
Tidsramme: 28 weeks gestational age
|
28 weeks gestational age
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TNF-alpha
Tidsramme: 28 weeks gestational age
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28 weeks gestational age
|
CRP
Tidsramme: 28 weeks gestational age
|
28 weeks gestational age
|
Birth weight
Tidsramme: 40 weeks gestational age
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40 weeks gestational age
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Apgar score
Tidsramme: 40 weeks gestational age
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40 weeks gestational age
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Adoption and maintenance of exercise during pregnancy
Tidsramme: 40 weeks gestational age
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40 weeks gestational age
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
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.
Generelle publikasjoner
- Hawkins M, Chasan-Taber L, Marcus B, Stanek E, Braun B, Ciccolo J, Markenson G. Impact of an exercise intervention on physical activity during pregnancy: the behaviors affecting baby and you study. Am J Public Health. 2014 Oct;104(10):e74-81. doi: 10.2105/AJPH.2014.302072. Epub 2014 Aug 14.
- Hawkins M, Braun B, Marcus BH, Stanek E 3rd, Markenson G, Chasan-Taber L. The impact of an exercise intervention on C - reactive protein during pregnancy: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Jun 24;15:139. doi: 10.1186/s12884-015-0576-2.
- Nobles C, Marcus BH, Stanek EJ 3rd, Braun B, Whitcomb BW, Solomon CG, Manson JE, Markenson G, Chasan-Taber L. Effect of an exercise intervention on gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1195-1204. doi: 10.1097/AOG.0000000000000738.
- Chasan-Taber L, Silveira M, Marcus BH, Braun B, Stanek E, Markenson G. Feasibility and efficacy of a physical activity intervention among pregnant women: the behaviors affecting baby and you (B.A.B.Y.) study. J Phys Act Health. 2011 Sep;8 Suppl 2(0 2):S228-38.
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
Ytterligere relevante MeSH-vilkår
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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