Balance After Baby Intervention for Women With Recent Gestational Diabetes

NCT02744300 | Completed

• 1 other identifier: 6201.25-S01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitus (GDM) in most recent pregnancy

Outcome Measures

Primary Outcomes (1)

• Weight loss

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

  12 months after delivery

Secondary Outcomes (4)

• Weight loss

  24 months after delivery

• Diabetes

  6 weeks, 12 months, and 24 months after delivery

• Number of participants with a fasting glucose level greater than 100 mg/dL

  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

  6 weeks, 12 months, and 24 months postpartum

Study Arms (2)

BABI-2 Lifestyle Intervention

EXPERIMENTAL

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

Post-GDM Follow-up Group

NO INTERVENTION

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

Interventions

BABI-2 Lifestyle Intervention 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.

Also known as: Balance After Baby 2 Lifestyle Intervention Program

BABI-2 Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80202, United States

Location

Related Publications (7)

• 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.

  PMID: 7148898 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 20395581 BACKGROUND

• 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.

  PMID: 18020897 BACKGROUND

• 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.

  PMID: 11847682 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37097924 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

• Jacinda Nicklas, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 20, 2016
• Study Start: September 1, 2016
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)