- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158131
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The landmark Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes (Knowler, Barrett-Connor et al. 2002). These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender (Knowler, Barrett-Connor et al. 2002). However, the DPP lacks a specific focus on new mothers with a recent history of gestational diabetes despite their documented high risk for developing Type 2 diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks (Kim et al., 2007). The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation (Walker, 1999; Swan et al., 2007). New mothers may have difficulties engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care (Swan, Kilmartin, and Liaw, 2007).
Modeled around the barriers identified in literature and gleaned from the focus groups and informant interviews of the preliminary study (2009p-000042), we have created a lifestyle/behavioral intervention that utilizes a modified DPP.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter & Coustan, 1982)
- Women with a glucose value >200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included
- 18-45 years old
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 40 kg/m2
- Six weeks postpartum body mass index between 25 and 50 kg/m2
- Capable of providing informed consent
Exclusion Criteria:
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Pre-pregnancy body mass index <18 kg/m2 (underweight) or >40 kg/m2 (morbidly obese)
- Current pregnancy
- Six weeks postpartum body mass index <25 kg/m2 or >50 kg/m2
- Excessive alcohol intake defined as >1 beverage per night or past history of alcohol abuse (within the previous 5 years)
- Current or past recreational drug use (within the previous 5 years)
- Diagnosis of diseases associated with glucose metabolism
- Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal medications
- Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
- Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
- Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Other active medical problems detected by examination or laboratory testing
- Plans to be in a different geographic area within the year
- Unable to give informed consent
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Intervention group
Participants in this group will take part in the lifestyle intervention.
|
Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.
|
No Intervention: Post-gestational diabetes mellitus (GDM) Follow-up Group
Participants in this group will not take part in the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum weight loss
Time Frame: 12 months after delivery
|
Postpartum weight loss for all subjects will be assessed.
|
12 months after delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen W Seely, MD, Brigham and Women's Hospital
Publications and helpful links
General Publications
- Nicklas JM, Zera CA, England LJ, Rosner BA, Horton E, Levkoff SE, Seely EW. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2014 Sep;124(3):563-570. doi: 10.1097/AOG.0000000000000420.
- Nicklas JM, Miller LJ, Zera CA, Davis RB, Levkoff SE, Seely EW. Factors associated with depressive symptoms in the early postpartum period among women with recent gestational diabetes mellitus. Matern Child Health J. 2013 Nov;17(9):1665-72. doi: 10.1007/s10995-012-1180-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009p002118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Diabetes Mellitus
-
IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
-
UPECLIN HC FM Botucatu UnespCompletedGestational Diabetes Mellitus | Pregestational Diabetes Mellitus | Mild Gestational HyperglycemiaBrazil
-
University of California, San FranciscoSan Francisco Department of Public Health; San Francisco General Hospital; Sonoma...CompletedType 2 Diabetes Mellitus | Gestational Diabetes MellitusUnited States
-
Assistance Publique - Hôpitaux de ParisActive, not recruitingGestational Diabetes Mellitus in PregnancyFrance
-
i-Health, Inc.CompletedGestational Diabetes Mellitus in PregnancyGermany
-
The Danish Center for Strategic Research on Type...Odense University HospitalCompletedGestational Diabetes Mellitus in PregnancyDenmark
-
Services Institute of Medical Sciences, PakistanCompletedGestational Diabetes Mellitus in PregnancyPakistan
-
Danone Asia Pacific Holdings Pte, Ltd.Nutricia ResearchTerminatedGestational Diabetes Mellitus in PregnancySingapore
-
Athabasca UniversityCompletedDiabetes Mellitus Gestational Previous PregnancyCanada
-
Federal State Budgetary Institution, V. A. Almazov...RecruitingGestational Diabetes Mellitus (GDM)Russian Federation
Clinical Trials on Balance after Baby Lifestyle Intervention Program
-
Brigham and Women's HospitalUniversity of Colorado, DenverCompletedGestational Diabetes MellitusUnited States
-
Universidad de SonoraUnknown
-
University of ArkansasCompletedOverweight | Memory Disorder
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Cardiovascular Risk Factor | Diabetes Mellitus Risk
-
VA Office of Research and DevelopmentCompletedObesity | Diabetes | Weight GainUnited States
-
Marmara UniversityCompletedCerebral Palsy | Developmental Disability | Development, Infant | Motor Disorders | PrematureTurkey
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
National Cheng Kung UniversityNational Cheng-Kung University Hospital; E-DA HospitalUnknown
-
Medical College of WisconsinLoyola University ChicagoCompletedBreast Cancer | Gynecologic CancerUnited States
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI); Public Health Foundation... and other collaboratorsCompletedObesity | Diabetes | Heart DiseaseIndia