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Completed

NCT Number: NCT00924599

A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women

The purpose of this study is to examine the feasibility of recruiting and providing a behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sierra Vista Regional Medical Center

San Luis Obispo, California, 93405, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • GDM in last pregnancy
  • BMI 30-40
  • Age 18-40
  • 1-5 years since last pregnancy
  • Non-smoking
  • English or Spanish speaking
  • Planning to have a baby but willing to use birth control during the 3 month weight loss program

Exclusion criteria

  • 3 or more miscarriages
  • History of infertility
  • Type 1 or Type 2 diabetes
  • Any weight loss since last pregnancy (based on last pre-pregnancy weight)
  • History of major psychiatric illness, drug abuse, or unsafe dieting practices
  • History of bariatric surgery, major medical conditions that prohibit physical activity or dietary intervention (MD consent may be required)

Treatment and study plan

Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)

Behavioral

Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.

Lifestyle education (English & Spanish)

Behavioral

The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.

Primary outcomes

  1. Gestational diabetes not present in pregnancy

    Time frame: from conception to delivery

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Registry information

Official study title

Prevention of Gestational Diabetes Pilot Study

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2009
Registry last updated
Jul 26, 2016

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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