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

Kaiser Permanente

Status: Completed

Conditions: Gestational Diabetes

Treatments: Behavioral: Lifestyle Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01489163

CN-03AFerr-02-H

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 2 patient groups

Lifestyle Counseling

Experimental group

Treatment:

Behavioral: Lifestyle Counseling

Control

No Intervention group