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

Translational Diabetes Prevention in GDM

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01489163

Acronym

APPLES

Enrollment

352

Registered

2011-12-09

Start date

2011-12-31

Completion date

2017-12-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention

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.

Interventions

BEHAVIORALLifestyle 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
postpartum body weight	through 24 months postpartum

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026