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

Gestational Diabetes Clinical Trial

— APPLES  

Official title:

Translational Diabetes Prevention in GDM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489163
• Other study ID #: CN-03AFerr-02-H
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2017

Study information

• Verified date: February 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: December 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Division of Research Northern California	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum body weight		through 24 months postpartum
Secondary	the proportion of women who reach body weight goals		through 24 months postpartum
Secondary	percent of calories from fat		through 24 months postpartum
Secondary	time spent in physical activity (PA) by intensity		through 24 months postpartum
Secondary	postpartum glycemia		through 24 months postpartum

External Links

•   Dr. Ferrara's web page