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Gestational DiabetesNCT01809431

Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

A study testing Intervention in people with Gestational Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
May 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UNC-Rex Health Care

    Raleigh, North Carolina, 27607

  • WakeMed

    Raleigh, North Carolina, 27610

Other trials in United States

About this study

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.

Read the 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.

Being tested
Intervention
Keywords
gestational diabetes, women, infants, blood glucose, weight, adiposity, health behaviors, self-efficacy
Medical subject headings
Diabetes, Gestational, Body Weight, Obesity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Also called breastfeeding education, progression to prediabetes and type 2 diabetes education, nutrition education, exercise education

    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.

Study groups in NCT01809431
Study groupRoleWhat they receive
interventionExperimentalBreastfeeding, 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.
Receives: Behavioral: Intervention
Wait-listed control groupNo interventionWait-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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting blood glucose

    Change in fasting blood glucose in mothers

    Measured: Baseline to 10 months postpartum

  2. weight (body mass index)

    Change in weight (body mass index)in mothers

    Measured: Baseline to 10 months postpartum

Secondary outcomes (11)
  1. oral glucose tolerance test

    Change in oral glucose tolerance test in mothers

    Measured: Baseline to 10 months postpartum

  2. insulin levels

    Change in insulin levels in mothers

    Measured: Baseline to 10 months postpartum

  3. homeostasis model assessment

    Change in homeostasis model assessment calculation in mothers

    Measured: Baseline to 10 months postpartum

  4. hemoglobin A1c

    Change in hemoglobin A1c in mothers

    Measured: Baseline to 10 months postpartum

  5. complete lipid panel

    Change in complete lipid panel in mothers

    Measured: Baseline to 10 months postpartum

  6. blood pressure

    Change in blood pressure in mothers

    Measured: Baseline to 10 months postpartum

  7. adiposity

    Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers

    Measured: Baseline to 10 months

  8. health behaviors

    Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers

    Measured: Baseline to 10 months postpartum

  9. self-efficacy

    Change in self-efficacy in mothers

    Measured: Baseline to 10 months postpartum

  10. infant weight status

    weight status (weight-for-length) in children

    Measured: Birth to 10 months

  11. breastfeeding

    Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants

    Measured: Birth to 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809431
Sponsor's protocol ID
12-0486
Other IDs
1R21DK092750-01A1
Status last verified
Jun 2015
First submitted
10 Mar 2013
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27782758
  • 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.

    PubMed 24112417

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Gestational Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting blood glucose (time frame: Baseline to 10 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809431, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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