- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01158131
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The landmark Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes (Knowler, Barrett-Connor et al. 2002). These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender (Knowler, Barrett-Connor et al. 2002). However, the DPP lacks a specific focus on new mothers with a recent history of gestational diabetes despite their documented high risk for developing Type 2 diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks (Kim et al., 2007). The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation (Walker, 1999; Swan et al., 2007). New mothers may have difficulties engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care (Swan, Kilmartin, and Liaw, 2007).
Modeled around the barriers identified in literature and gleaned from the focus groups and informant interviews of the preliminary study (2009p-000042), we have created a lifestyle/behavioral intervention that utilizes a modified DPP.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02115
- Brigham and Women's Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter & Coustan, 1982)
- Women with a glucose value >200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included
- 18-45 years old
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 40 kg/m2
- Six weeks postpartum body mass index between 25 and 50 kg/m2
- Capable of providing informed consent
Exclusion Criteria:
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Pre-pregnancy body mass index <18 kg/m2 (underweight) or >40 kg/m2 (morbidly obese)
- Current pregnancy
- Six weeks postpartum body mass index <25 kg/m2 or >50 kg/m2
- Excessive alcohol intake defined as >1 beverage per night or past history of alcohol abuse (within the previous 5 years)
- Current or past recreational drug use (within the previous 5 years)
- Diagnosis of diseases associated with glucose metabolism
- Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal medications
- Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
- Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
- Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Other active medical problems detected by examination or laboratory testing
- Plans to be in a different geographic area within the year
- Unable to give informed consent
- Non-English speaking
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Lifestyle Intervention group
Participants in this group will take part in the lifestyle intervention.
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Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.
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Ei väliintuloa: Post-gestational diabetes mellitus (GDM) Follow-up Group
Participants in this group will not take part in the intervention.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Postpartum weight loss
Aikaikkuna: 12 months after delivery
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Postpartum weight loss for all subjects will be assessed.
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12 months after delivery
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Ellen W Seely, MD, Brigham and Women's Hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Nicklas JM, Zera CA, England LJ, Rosner BA, Horton E, Levkoff SE, Seely EW. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2014 Sep;124(3):563-570. doi: 10.1097/AOG.0000000000000420.
- Nicklas JM, Miller LJ, Zera CA, Davis RB, Levkoff SE, Seely EW. Factors associated with depressive symptoms in the early postpartum period among women with recent gestational diabetes mellitus. Matern Child Health J. 2013 Nov;17(9):1665-72. doi: 10.1007/s10995-012-1180-y.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2009p002118
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