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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
  Purpose

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.


Condition Intervention
Gestational Diabetes
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809431

Locations
United States, North Carolina
UNC-Rex Health Care
Raleigh, North Carolina, United States, 27607
WakeMed
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Diane Berry, PhD, ANP-BC University of North Carolina, Chapel Hill
Principal Investigator: Alison Stuebe, MD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diane Berry, PhD, ANP-BC, Lead Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01809431     History of Changes
Other Study ID Numbers: 12-0486, 1R21DK092750-01A1
Study First Received: March 10, 2013
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
gestational diabetes
women
infants
blood glucose
weight
adiposity
health behaviors
self-efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on November 27, 2014