MedPath

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

Not Applicable
Completed
Conditions
Gestational Diabetes
Interventions
Behavioral: Lifestyle Counseling
Registration Number
NCT01489163
Lead Sponsor
Kaiser Permanente
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
352
Inclusion Criteria
  • Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
  • Pregnancy complicated by high glucose levels starting November 2011
Exclusion Criteria
  • Recognized DM prior to pregnancy
  • Uncontrolled hypertension during pregnancy
  • Severe active thyroid disease during pregnancy
  • Severe diseases of the cardio-pulmonary system
  • Diagnosis of a severe psychiatric disorder
  • Diagnosis of cancer
  • Conditions that lead to diet changes
  • Addiction to alcohol or illegal drugs
  • Current corticosteroid medicine use

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lifestyle CounselingLifestyle Counseling-
Primary Outcome Measures
NameTimeMethod
postpartum body weightthrough 24 months postpartum
Secondary Outcome Measures
NameTimeMethod
time spent in physical activity (PA) by intensitythrough 24 months postpartum
the proportion of women who reach body weight goalsthrough 24 months postpartum
percent of calories from fatthrough 24 months postpartum
postpartum glycemiathrough 24 months postpartum

Trial Locations

Locations (1)

Division of Research Northern California

🇺🇸

Oakland, California, United States

© Copyright 2025. All Rights Reserved by MedPath