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OpenTrials
Completed

NCT Number: NCT02763150

Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.

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Key information

Conditions

Gestational Diabetes Mellitus 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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University, San Luis Obispo, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Prior diagnosis of gestational diabetes.
  • BMI > 25 kg/m2
  • Planning to have a baby in the next 1-3 years
  • English or Spanish speaking

Exclusion criteria

  • Age less than 18 years
  • Women with Type 2 or Type 1 diabetes
  • Current pregnancy
  • Relocating in the next 2 years
  • Medications that affect weight/diabetes
  • Serious current physical disease
  • History of eating disorders
  • History of bariatric surgery
  • Current problems with drug abuse
  • Current treatment of a serious psychological disorder

Treatment and study plan

Lifestyle Intervention

Behavioral

Intervention group will receive comprehensive behavioral weight loss program.

Health Promotion

Other

The health promotion group will receive education on healthy eating and activity

Primary outcomes

  1. Incidence of Gestational Diabetes Mellitus

    Time frame: 26 weeks gestation

Secondary outcomes

  1. Changes in maternal levels of fasting glucose

    Time frame: study entry, 16 weeks, 26 weeks gestation

  2. Changes in maternal levels of fasting insulin

    Time frame: study entry, 16 weeks, 26 weeks gestation

  3. Changes in maternal levels of systolic and diastolic blood pressure

    Time frame: study entry, 16 weeks, 26 weeks gestation

  4. Changes in maternal levels of C-reactive protein

    Time frame: study entry, 16 weeks, 26 weeks gestation

  5. Incidence of preeclampsia

    Time frame: Delivery

  6. Incidence of cesarean delivery

    Time frame: Delivery

  7. Weight changes

    Time frame: study entry, 16 weeks, 26 weeks gestation

  8. Daily caloric intake

    Time frame: study entry, 16 weeks, 26 weeks gestation

  9. Minutes per week of moderate physical activity

    Time frame: study entry, 16 weeks, 26 weeks gestation

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • Brown University

Registry information

Official study title

Gestational Diabetes Prevention Program

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 5, 2016
Registry last updated
Aug 2, 2022

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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