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

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle intervention
Health Promotion
Sponsored by
California Polytechnic State University-San Luis Obispo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Gestational Diabetes Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • California Polytechnic State University
  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Intervention

Health Promotion

Arm Description

Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.

Health promotion group will receive education on healthy eating and activity before pregnancy.

Outcomes

Primary Outcome Measures

Incidence of Gestational Diabetes Mellitus

Secondary Outcome Measures

Changes in maternal levels of fasting glucose
Changes in maternal levels of fasting insulin
Changes in maternal levels of systolic and diastolic blood pressure
Changes in maternal levels of C-reactive protein
Incidence of preeclampsia
Incidence of cesarean delivery
Weight changes
Daily caloric intake
Minutes per week of moderate physical activity

Full Information

First Posted
April 29, 2016
Last Updated
July 30, 2022
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT02763150
Brief Title
Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women
Official Title
Gestational Diabetes Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational Diabetes Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.
Arm Title
Health Promotion
Arm Type
Active Comparator
Arm Description
Health promotion group will receive education on healthy eating and activity before pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Intervention group will receive comprehensive behavioral weight loss program.
Intervention Type
Other
Intervention Name(s)
Health Promotion
Intervention Description
The health promotion group will receive education on healthy eating and activity
Primary Outcome Measure Information:
Title
Incidence of Gestational Diabetes Mellitus
Time Frame
26 weeks gestation
Secondary Outcome Measure Information:
Title
Changes in maternal levels of fasting glucose
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Changes in maternal levels of fasting insulin
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Changes in maternal levels of systolic and diastolic blood pressure
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Changes in maternal levels of C-reactive protein
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Incidence of preeclampsia
Time Frame
Delivery
Title
Incidence of cesarean delivery
Time Frame
Delivery
Title
Weight changes
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Daily caloric intake
Time Frame
study entry, 16 weeks, 26 weeks gestation
Title
Minutes per week of moderate physical activity
Time Frame
study entry, 16 weeks, 26 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33827659
Citation
Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w.
Results Reference
derived

Learn more about this trial

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

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