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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Gestational Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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. Receives: Behavioral: Intervention |
| Wait-listed control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
Change in fasting blood glucose in mothers
Measured: Baseline to 10 months postpartum
weight (body mass index)
Change in weight (body mass index)in mothers
Measured: Baseline to 10 months postpartum
Secondary outcomes (11)
oral glucose tolerance test
Change in oral glucose tolerance test in mothers
Measured: Baseline to 10 months postpartum
insulin levels
Change in insulin levels in mothers
Measured: Baseline to 10 months postpartum
homeostasis model assessment
Change in homeostasis model assessment calculation in mothers
Measured: Baseline to 10 months postpartum
hemoglobin A1c
Change in hemoglobin A1c in mothers
Measured: Baseline to 10 months postpartum
complete lipid panel
Change in complete lipid panel in mothers
Measured: Baseline to 10 months postpartum
blood pressure
Change in blood pressure in mothers
Measured: Baseline to 10 months postpartum
adiposity
Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
Measured: Baseline to 10 months
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
self-efficacy
Change in self-efficacy in mothers
Measured: Baseline to 10 months postpartum
infant weight status
weight status (weight-for-length) in children
Measured: Birth to 10 months
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.
- First posted12 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane Berry, PhD, ANP-BC, Principal investigator, University of North Carolina, Chapel HillAlison Stuebe, MD, Principal investigator, University of North Carolina, Chapel Hill
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 27782758Berry 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
- ClinicalTrials.gov ID
- NCT01809431
- Acronym / sponsor ID
- 12-0486
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, women, infants, blood glucose, weight, adiposity, health behaviors, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: InterventionBreastfeeding, 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. |
| Wait-listed control group | No intervention | –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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: breastfeeding education, progression to prediabetes and type 2 diabetes education, nutrition education, exercise educationUsing 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. | Behavioural | intervention |
Primary outcome
fasting blood glucose
Time frame: Baseline to 10 months postpartum
Change in fasting blood glucose in mothers
weight (body mass index)
Time frame: Baseline to 10 months postpartum
Change in weight (body mass index)in mothers
11 secondary outcomes
oral glucose tolerance test
Time frame: Baseline to 10 months postpartum
insulin levels
Time frame: Baseline to 10 months postpartum
homeostasis model assessment
Time frame: Baseline to 10 months postpartum
hemoglobin A1c
Time frame: Baseline to 10 months postpartum
complete lipid panel
Time frame: Baseline to 10 months postpartum
blood pressure
Time frame: Baseline to 10 months postpartum
adiposity
Time frame: Baseline to 10 months
health behaviors
Time frame: Baseline to 10 months postpartum
self-efficacy
Time frame: Baseline to 10 months postpartum
infant weight status
Time frame: Birth to 10 months
breastfeeding
Time frame: Birth to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 27782758Stuebe 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.
- Derived from this study: PubMed 24112417Berry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Berry, PhD, ANP-BC principal investigator
University of North Carolina, Chapel Hill
Alison Stuebe, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
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.