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Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance

NCT01489163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2019-02-04

No results posted yet for this study

Summary

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

Conditions

  • Gestational Diabetes

Interventions

BEHAVIORAL

Lifestyle Counseling

The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Assiamira Ferrara, MD, PhD · Kaiser Permanente Division of Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-10-31
Completion
2017-12-31

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 NCT01489163 on ClinicalTrials.gov