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Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01809431
First received: March 10, 2013
Last updated: November 6, 2013
Last verified: November 2013

March 10, 2013
November 6, 2013
May 2012
January 2014   (final data collection date for primary outcome measure)
  • fasting blood glucose [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in fasting blood glucose in mothers
  • weight (body mass index) [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in weight (body mass index)in mothers
Same as current
Complete list of historical versions of study NCT01809431 on ClinicalTrials.gov Archive Site
  • oral glucose tolerance test [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in oral glucose tolerance test in mothers
  • insulin levels [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in insulin levels in mothers
  • homeostasis model assessment [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in homeostasis model assessment calculation in mothers
  • hemoglobin A1c [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c in mothers
  • complete lipid panel [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in complete lipid panel in mothers
  • blood pressure [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in blood pressure in mothers
  • adiposity [ Time Frame: Baseline to 10 months ] [ Designated as safety issue: No ]
    Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
  • health behaviors [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
  • self-efficacy [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in self-efficacy in mothers
  • infant weight status [ Time Frame: Birth to 10 months ] [ Designated as safety issue: No ]
    weight status (weight-for-length) in children
  • breastfeeding [ Time Frame: Birth to 10 months ] [ Designated as safety issue: No ]
    Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
  • oral glucose tolerance test [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in oral glucose tolerance test in mothers
  • insulin levels [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in insulin levels in mothers
  • homeostasis model assessment [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in homeostasis model assessment calculation in mothers
  • hemoglobin A1c [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c in mothers
  • complete lipid panel [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in complete lipid panel in mothers
  • blood pressure [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in blood pressure in mothers
  • adiposity [ Time Frame: Baseline to 10 months ] [ Designated as safety issue: No ]
    Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
  • health behaviors [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
  • self-efficacy [ Time Frame: Baseline to 10 months postpartum ] [ Designated as safety issue: No ]
    Change in self-efficacy (Eating Self-Efficacy, Exercise Self-Efficacy Scale, and Breastfeeding Self-Efficacy Scale)in mothers
  • infant weight status [ Time Frame: Birth to 10 months ] [ Designated as safety issue: No ]
    weight status (weight-for-length) in children
  • breastfeeding [ Time Frame: Birth to 10 months ] [ Designated as safety issue: No ]
    Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
Not Provided
Not Provided
 
Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Gestational Diabetes
Behavioral: Intervention
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.
Other Names:
  • breastfeeding education
  • progression to prediabetes and type 2 diabetes education
  • nutrition education
  • exercise education
  • coping skills training
  • exercise training
  • home-based exercise program
  • educational and motivational text messaging
  • Experimental: 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.
    Intervention: Behavioral: Intervention
  • No Intervention: 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 2014
January 2014   (final data collection date for primary outcome measure)

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)
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01809431
12-0486, 1R21DK092750-01A1
Yes
Diane Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Diane Berry, PhD, ANP-BC University of North Carolina, Chapel Hill
Principal Investigator: Alison Stuebe, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP