- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01809431
Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
1. juni 2015 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
200
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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North Carolina
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Raleigh, North Carolina, Forente stater, 27610
- Wakemed
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Raleigh, North Carolina, Forente stater, 27607
- UNC-Rex Health Care
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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 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
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Ingen inngripen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
fasting blood glucose
Tidsramme: Baseline to 10 months postpartum
|
Change in fasting blood glucose in mothers
|
Baseline to 10 months postpartum
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weight (body mass index)
Tidsramme: Baseline to 10 months postpartum
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Change in weight (body mass index)in mothers
|
Baseline to 10 months postpartum
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
oral glucose tolerance test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to 10 months postpartum
|
Change in blood pressure in mothers
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Baseline to 10 months postpartum
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adiposity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
- Hovedetterforsker: Alison Stuebe, MD, University of North Carolina, Chapel Hill
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
- 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.
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. mai 2012
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først innsendt
10. mars 2013
Først innsendt som oppfylte QC-kriteriene
10. mars 2013
Først lagt ut (Anslag)
12. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12-0486
- 1R21DK092750-01A1 (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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