- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01809431
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
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
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27610
- Wakemed
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Raleigh, North Carolina, Förenta staterna, 27607
- UNC-Rex Health Care
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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.
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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:
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
fasting blood glucose
Tidsram: Baseline to 10 months postpartum
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Change in fasting blood glucose in mothers
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Baseline to 10 months postpartum
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weight (body mass index)
Tidsram: Baseline to 10 months postpartum
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Change in weight (body mass index)in mothers
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Baseline to 10 months postpartum
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
oral glucose tolerance test
Tidsram: Baseline to 10 months postpartum
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Change in oral glucose tolerance test in mothers
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Baseline to 10 months postpartum
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insulin levels
Tidsram: Baseline to 10 months postpartum
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Change in insulin levels in mothers
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Baseline to 10 months postpartum
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homeostasis model assessment
Tidsram: Baseline to 10 months postpartum
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Change in homeostasis model assessment calculation in mothers
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Baseline to 10 months postpartum
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hemoglobin A1c
Tidsram: Baseline to 10 months postpartum
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Change in hemoglobin A1c in mothers
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Baseline to 10 months postpartum
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complete lipid panel
Tidsram: Baseline to 10 months postpartum
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Change in complete lipid panel in mothers
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Baseline to 10 months postpartum
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blood pressure
Tidsram: Baseline to 10 months postpartum
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Change in blood pressure in mothers
|
Baseline to 10 months postpartum
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adiposity
Tidsram: Baseline to 10 months
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Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
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Baseline to 10 months
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health behaviors
Tidsram: Baseline to 10 months postpartum
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Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
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Baseline to 10 months postpartum
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self-efficacy
Tidsram: Baseline to 10 months postpartum
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Change in self-efficacy in mothers
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Baseline to 10 months postpartum
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infant weight status
Tidsram: Birth to 10 months
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weight status (weight-for-length) in children
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Birth to 10 months
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breastfeeding
Tidsram: Birth to 10 months
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Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
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Birth to 10 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
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.
Allmänna publikationer
- Stuebe AM, Bonuck K, Adatorwovor R, Schwartz TA, Berry DC. A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Breastfeed Med. 2016 Dec;11(10):504-513. doi: 10.1089/bfm.2016.0069. Epub 2016 Oct 26.
- Berry DC, Neal M, Hall EG, Schwartz TA, Verbiest S, Bonuck K, Goodnight W, Brody S, Dorman KF, Menard MK, Stuebe AM. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study. BMC Pregnancy Childbirth. 2013 Oct 10;13:184. doi: 10.1186/1471-2393-13-184.
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
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-0486
- 1R21DK092750-01A1 (U.S.S. NIH-anslag/kontrakt)
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 .
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