ClinicalTrials.gov
ClinicalTrials.gov Menu

Balance After Baby Intervention for Women With Recent Gestational Diabetes (BABI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02744300
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

Brief Summary:

Women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM. This program, delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical activity. The purpose of the current study, called Balance After Baby Intervention 2 (BABI-2), is to study a larger group of women with two years of follow-up. We will assess whether women assigned to the intervention group lose more weight and decrease their risk factors for type 2 diabetes.

Participants assigned to the BAB lifestyle 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.

Participants assigned to the post-GDM follow-up group will have access to a website containing links to information about diabetes prevention.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: BABI-2 Lifestyle Intervention Not Applicable

Detailed Description:

The landmark Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes. These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender. However, the DPP does not have a specific focus on new mothers with a recent history of gestational 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.

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. New mothers may have difficulty engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care. In response to the barriers identified in literature and gleaned from the focus groups and informant interviews of a preliminary study (2009p000042), we created a lifestyle/behavioral intervention that utilizes a modified DPP.

In 2012 we completed a one year pilot study (2009p002118) to assess the feasibility and effectiveness of the lifestyle/behavioral intervention. The pilot study demonstrated that women in the intervention group lost more weight and were closer to pre-pregnancy weight that the control group.

Our goals in Phase 2 of the study are: to gather more data about the effects of the intervention at 12 months; to determine if the greater weight loss observed in the pilot intervention arm at 12 months can be replicated with a larger number of women and maintained at 24 months; and to see whether there is a significant effect on glucose tolerance in the intervention arm at 24 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus
Study Start Date : June 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: BABI-2 Lifestyle Intervention
Participants in this group will take part in the web-based lifestyle intervention which includes access to the lifestyle intervention website and personalized coaching from a Lifestyle Coach.
Behavioral: BABI-2 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.
Other Name: Balance After Baby 2 Lifestyle Intervention Program

No Intervention: Post-GDM Follow-up Group
Participants in this group will have access to a separate website containing links to information about diabetes prevention.



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 12 months after delivery ]
    Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 24 months after delivery ]
    Postpartum weight loss will be measured from 6 weeks postpartum to 24 months postpartum

  2. Diabetes [ Time Frame: 6 weeks, 12 months, and 24 months after delivery ]
    Risk factors or diagnosis of diabetes will be assessed in all participants via oral glucose tolerance tests (OGTTs) and by measuring glycated hemoglobin (HbA1c).

  3. Number of participants with a fasting glucose level greater than 100 mg/dL [ Time Frame: 6 months and 18 months postpartum ]
  4. Number of participants with either: a HbA1c value greater than or equal to 5.7; or a 2 hour value on a 75 g oral glucose tolerance test of greater than or equal to 140 [ Time Frame: 6 weeks, 12 months, and 24 months postpartum ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 years of age or older
  • No personal history of Type 1 or 2 diabetes
  • Pre-pregnancy body mass index between 18 and 50 kg/m2
  • Six weeks postpartum body mass index between 24 and 50 kg/m2 (>22 for Asians)
  • Daily access to the internet
  • English or Spanish speaking
  • Capable of providing informed consent

Exclusion Criteria:

  • Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
  • Current pregnancy
  • Premature delivery < 34 weeks gestation
  • Diagnosis of diseases associated with glucose metabolism
  • Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study
  • Taking certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.), or other prescription weight loss 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 next 6 months
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744300


Contacts
Contact: Jennifer Dias, BA 617 732 8538 jmdias@partners.org
Contact: Ellen W Seely, MD 617 732 5012 eseely@partners.org

Locations
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80202
Contact: Danielle Cook    303-724-8998    danielle.cook@ucdenver.edu   
Contact: Jacinda Nicklas, MD, MPH, MA       jacinda.nicklas@ucdenver.edu   
Principal Investigator: Jacinda Nicklas, MD, MPH, MA         
Sponsors and Collaborators
Brigham and Women's Hospital
University of Colorado, Denver
Investigators
Principal Investigator: Ellen W Seely, MD Brigham and Women's Hospital
Principal Investigator: Jacinda Nicklas, MD University of Colorado, Denver

Publications:
Responsible Party: Ellen W. Seely, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02744300     History of Changes
Other Study ID Numbers: 6201.25-S01
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Gestational diabetes mellitus (GDM) in most recent pregnancy

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