Clinical trial NCT02744300: Balance After Baby Intervention for Women With Recent Gestational Diabetes
Official title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational diabetes mellitus (GDM) in most recent pregnancy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2016-04-20
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight loss
timeFrame: 12 months after delivery
Secondary outcomes:
measure: Weight loss
timeFrame: 24 months after delivery
measure: Diabetes
timeFrame: 6 weeks, 12 months, and 24 months after delivery
measure: Number of participants with a fasting glucose level greater than 100 mg/dL
timeFrame: 6 months and 18 months postpartum
measure: 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
timeFrame: 6 weeks, 12 months, and 24 months postpartum
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Brigham and Women's Hospital
name: Ellen W Seely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jacinda Nicklas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.