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

July 30, 2022 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo

Gestational Diabetes Prevention Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93401
        • California Polytechnic State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention
Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.
Behavioral: Lifestyle intervention
Intervention group will receive comprehensive behavioral weight loss program.
Active Comparator: Health Promotion
Health promotion group will receive education on healthy eating and activity before pregnancy.
Other: Health Promotion
The health promotion group will receive education on healthy eating and activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Gestational Diabetes Mellitus
Time Frame: 26 weeks gestation
26 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in maternal levels of fasting glucose
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of fasting insulin
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of systolic and diastolic blood pressure
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of C-reactive protein
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Incidence of preeclampsia
Time Frame: Delivery
Delivery
Incidence of cesarean delivery
Time Frame: Delivery
Delivery
Weight changes
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Daily caloric intake
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation
Minutes per week of moderate physical activity
Time Frame: study entry, 16 weeks, 26 weeks gestation
study entry, 16 weeks, 26 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Collaborators

Brown University

Investigators

  • Principal Investigator: Suzanne Phelan, PhD, California Polytechnic State University-San Luis Obispo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 30, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-GDPP-trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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