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Balance After Baby Intervention for Women With Recent Gestational Diabetes

NCT02744300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-07-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Ellen W Seely, MD · Brigham and Women's Hospital

  • Jacinda Nicklas, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-07-29
Completion
2019-07-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744300 on ClinicalTrials.gov