Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)

NCT01158131 | Completed Phase 2

• 1 other identifier: 2009p002118
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether 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, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitus (GDM) in the most recent pregnancy

Outcome Measures

Primary Outcomes (1)

• Postpartum weight loss

  Postpartum weight loss for all subjects will be assessed.

  12 months after delivery

Study Arms (2)

Lifestyle Intervention group

EXPERIMENTAL

Participants in this group will take part in the lifestyle intervention.

Behavioral: Balance after Baby Lifestyle Intervention Program

Post-gestational diabetes mellitus (GDM) Follow-up Group

NO INTERVENTION

Participants in this group will not take part in the intervention.

Interventions

Balance after Baby Lifestyle Intervention Program 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. Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.

Lifestyle Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years old
• No personal history of Type 1 or 2 diabetes
• Pre-pregnancy body mass index between 18 and 40 kg/m2
• Six weeks postpartum body mass index between 25 and 50 kg/m2
• Capable of providing informed consent

You may not qualify if:

• Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
• Pre-pregnancy body mass index \<18 kg/m2 (underweight) or \>40 kg/m2 (morbidly obese)
• Current pregnancy
• Six weeks postpartum body mass index \<25 kg/m2 or \>50 kg/m2
• Excessive alcohol intake defined as \>1 beverage per night or past history of alcohol abuse (within the previous 5 years)
• Current or past recreational drug use (within the previous 5 years)
• Diagnosis of diseases associated with glucose metabolism
• Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal 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 year
• Unable to give informed consent
• Non-English speaking

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 25162257 DERIVED

• Nicklas JM, Miller LJ, Zera CA, Davis RB, Levkoff SE, Seely EW. Factors associated with depressive symptoms in the early postpartum period among women with recent gestational diabetes mellitus. Matern Child Health J. 2013 Nov;17(9):1665-72. doi: 10.1007/s10995-012-1180-y.

  PMID: 23124798 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ellen W Seely, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ellen W. Seely, MD

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 8, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

US (1)