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OpenTrials
Completed

NCT Number: NCT01489163

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

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.

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Key information

Conditions

Gestational Diabetes Behavior Body Weight Body Weight Changes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Loss

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Research Northern California

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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.

Primary outcomes

  1. postpartum body weight

    Time frame: through 24 months postpartum

Secondary outcomes

  1. the proportion of women who reach body weight goals

    Time frame: through 24 months postpartum

  2. percent of calories from fat

    Time frame: through 24 months postpartum

  3. time spent in physical activity (PA) by intensity

    Time frame: through 24 months postpartum

  4. postpartum glycemia

    Time frame: through 24 months postpartum

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Translational Diabetes Prevention in GDM

Acronym: APPLES

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Dec 9, 2011
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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