Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

1 juni 2015 uppdaterad av: Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
The purpose of this study is to determine whether a 14 week intervention is successful in improving outcomes for women with gestational diabetes mellitus and their infants.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Women who are diagnosed with gestational diabetes are at increased risk for developing prediabetes and type 2 diabetes. To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with gestational diabetes. Programs are needed that intervene in the prenatal period to teach women the importance of breastfeeding to improve metabolic control and infant health and continue after birth to promote improved nutrition and exercise patterns and weight loss. Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy. Trends in breastfeeding duration and intensity, maternal infant feeding behavior, infant growth trajectory (weight-for-length) will also be measured. A total of 100 African American, bilingual Hispanic, and non-Hispanic White women diagnosed with gestational diabetes will be inducted and randomized by site to either the experimental or wait-list control group. Data will be collected at Time 1 (Baseline at 22-36 weeks pregnant), Time 2 (6 weeks postpartum), Time 3 (4 months postpartum and completion of Phase I), Time 4 (7 months postpartum and completion of Phase II), and Time 5 (10 months postpartum and after 3 months on their own). Primary maternal outcomes will include fasting blood glucose and weight (BMI). Secondary maternal outcomes will include clinical outcomes (oral glucose tolerance test, insulin levels, Homeostasis Model Assessment calculation, Hemoglobin A1c, complete lipid panel, and blood pressure); adiposity (waist circumference, triceps and subscapular skin folds); health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days); and self-efficacy (Eating Self-Efficacy, Exercise Self-Efficacy Scale, and Breastfeeding Self-Efficacy Scale). Infant outcomes will include data on weight status (weight-for-length) and breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding). Data analysis will include analysis of field notes, post-intervention interviews, and recruitment and retention efforts. Linear mixed-effects random coefficients models will be constructed to measure the effects of the intervention compared to the wait-list control group. Increasing breastfeeding and decreasing overweight in postpartum women who were diagnosed with gestational diabetes may both improve maternal glucose homeostasis and weight and stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations.

Studietyp

Interventionell

Inskrivning (Faktisk)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Raleigh, North Carolina, Förenta staterna, 27610
        • Wakemed
      • Raleigh, North Carolina, Förenta staterna, 27607
        • UNC-Rex Health Care

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Women between 22-36 weeks of pregnancy who are diagnosed with GDM
  • A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
  • Age 18-45 years old
  • A pre-pregnancy body mass index > 25kg/m2

    • Ability to read and write in English
    • Willingness to consent for themselves and their infant

Exclusion Criteria:

  • They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: intervention
Breastfeeding, progression to type 2 diabetes, nutrition, and exercise education, coping skills training, exercise training, a home-based exercise program and educational and motivational text messaging.
Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy.
Andra namn:
  • träningsträning
  • amningsutbildning
  • progression to prediabetes and type 2 diabetes education
  • nutrition education
  • exercise education
  • coping skills training
  • home-based exercise program
  • educational and motivational text messaging
Inget ingripande: Wait-listed control group
Wait-listed control group receive usual care delivered by their health care provider and after completion of their time in the study they are offered the intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
fasting blood glucose
Tidsram: Baseline to 10 months postpartum
Change in fasting blood glucose in mothers
Baseline to 10 months postpartum
weight (body mass index)
Tidsram: Baseline to 10 months postpartum
Change in weight (body mass index)in mothers
Baseline to 10 months postpartum

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
oral glucose tolerance test
Tidsram: Baseline to 10 months postpartum
Change in oral glucose tolerance test in mothers
Baseline to 10 months postpartum
insulin levels
Tidsram: Baseline to 10 months postpartum
Change in insulin levels in mothers
Baseline to 10 months postpartum
homeostasis model assessment
Tidsram: Baseline to 10 months postpartum
Change in homeostasis model assessment calculation in mothers
Baseline to 10 months postpartum
hemoglobin A1c
Tidsram: Baseline to 10 months postpartum
Change in hemoglobin A1c in mothers
Baseline to 10 months postpartum
complete lipid panel
Tidsram: Baseline to 10 months postpartum
Change in complete lipid panel in mothers
Baseline to 10 months postpartum
blood pressure
Tidsram: Baseline to 10 months postpartum
Change in blood pressure in mothers
Baseline to 10 months postpartum
adiposity
Tidsram: Baseline to 10 months
Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
Baseline to 10 months
health behaviors
Tidsram: Baseline to 10 months postpartum
Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
Baseline to 10 months postpartum
self-efficacy
Tidsram: Baseline to 10 months postpartum
Change in self-efficacy in mothers
Baseline to 10 months postpartum
infant weight status
Tidsram: Birth to 10 months
weight status (weight-for-length) in children
Birth to 10 months
breastfeeding
Tidsram: Birth to 10 months
Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
Birth to 10 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
  • Huvudutredare: Alison Stuebe, MD, University of North Carolina, Chapel Hill

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2012

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

10 mars 2013

Först inskickad som uppfyllde QC-kriterierna

10 mars 2013

Första postat (Uppskatta)

12 mars 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

3 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2015

Senast verifierad

1 juni 2015

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Graviditetsdiabetes

Kliniska prövningar på Intervention

3
Prenumerera