Balance After Baby Intervention for Women With Recent Gestational Diabetes (BABI2)
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|ClinicalTrials.gov Identifier: NCT02744300|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : July 13, 2017
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|
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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Weight loss [ Time Frame: 12 months after delivery ]Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.
- Weight loss [ Time Frame: 24 months after delivery ]Postpartum weight loss will be measured from 6 weeks postpartum to 24 months postpartum
- 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).
- Number of participants with a fasting glucose level greater than 100 mg/dL [ Time Frame: 6 months and 18 months postpartum ]
- 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 ]
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
|Contact: Jennifer Dias, BA||617 732 firstname.lastname@example.org|
|Contact: Ellen W Seely, MD||617 732 email@example.com|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Denver, Colorado, United States, 80202|
|Contact: Danielle Cook 303-724-8998 firstname.lastname@example.org|
|Contact: Jacinda Nicklas, MD, MPH, MA email@example.com|
|Principal Investigator: Jacinda Nicklas, MD, MPH, MA|
|Principal Investigator:||Ellen W Seely, MD||Brigham and Women's Hospital|
|Principal Investigator:||Jacinda Nicklas, MD||University of Colorado, Denver|