Balance After Baby Intervention for Women With Recent Gestational Diabetes

NCT ID: NCT02744300

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-07-29

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

BABI-2 Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Post-GDM Follow-up Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Balance After Baby 2 Lifestyle Intervention Program

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen W. Seely

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen W Seely, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Jacinda Nicklas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 7148898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11832527 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20395581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18020897 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11847682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25162257 (View on PubMed)

Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.

Reference Type: DERIVED

PMID: 37097924 (View on PubMed)

Other Identifiers

6201.25-S01

Identifier Type: -

Identifier Source: org_study_id