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

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BABI-2 Lifestyle Intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Gestational diabetes mellitus (GDM) in most recent pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BABI-2 Lifestyle Intervention

Post-GDM Follow-up Group

Arm Description

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.

Participants in this group will have access to a separate website containing links to information about diabetes prevention.

Outcomes

Primary Outcome Measures

Weight loss
Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.

Secondary Outcome Measures

Weight loss
Postpartum weight loss will be measured from 6 weeks postpartum to 24 months postpartum
Diabetes
Risk factors or diagnosis of diabetes will be assessed in all participants via oral glucose tolerance tests (OGTTs) and by measuring glycated hemoglobin (HbA1c).
Number of participants with a fasting glucose level greater than 100 mg/dL
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

Full Information

First Posted
March 3, 2016
Last Updated
July 20, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02744300
Brief Title
Balance After Baby Intervention for Women With Recent Gestational Diabetes
Acronym
BABI2
Official Title
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational diabetes mellitus (GDM) in most recent pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BABI-2 Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Post-GDM Follow-up Group
Arm Type
No Intervention
Arm Description
Participants in this group will have access to a separate website containing links to information about diabetes prevention.
Intervention Type
Behavioral
Intervention Name(s)
BABI-2 Lifestyle Intervention
Other Intervention Name(s)
Balance After Baby 2 Lifestyle Intervention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.
Time Frame
12 months after delivery
Secondary Outcome Measure Information:
Title
Weight loss
Description
Postpartum weight loss will be measured from 6 weeks postpartum to 24 months postpartum
Time Frame
24 months after delivery
Title
Diabetes
Description
Risk factors or diagnosis of diabetes will be assessed in all participants via oral glucose tolerance tests (OGTTs) and by measuring glycated hemoglobin (HbA1c).
Time Frame
6 weeks, 12 months, and 24 months after delivery
Title
Number of participants with a fasting glucose level greater than 100 mg/dL
Time Frame
6 months and 18 months postpartum
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen W Seely, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacinda Nicklas, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7148898
Citation
Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
Results Reference
background
PubMed Identifier
11832527
Citation
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Results Reference
background
PubMed Identifier
20395581
Citation
Kim SY, England L, Wilson HG, Bish C, Satten GA, Dietz P. Percentage of gestational diabetes mellitus attributable to overweight and obesity. Am J Public Health. 2010 Jun;100(6):1047-52. doi: 10.2105/AJPH.2009.172890. Epub 2010 Apr 15.
Results Reference
background
PubMed Identifier
18020897
Citation
Swan W, Kilmartin G, Liaw ST. Assessment of readiness to prevent type 2 diabetes in a population of rural women with a history of gestational diabetes. Rural Remote Health. 2007 Oct-Dec;7(4):802. Epub 2007 Nov 19.
Results Reference
background
PubMed Identifier
11847682
Citation
Walker LO, Grobe SJ. The construct of thriving in pregnancy and postpartum. Nurs Sci Q. 1999 Apr;12(2):151-7. doi: 10.1177/089431849901200216.
Results Reference
background
PubMed Identifier
25162257
Citation
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.
Results Reference
background

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Balance After Baby Intervention for Women With Recent Gestational Diabetes

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