NCT02763150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4.3 years

First QC Date

April 29, 2016

Last Update Submit

July 30, 2022

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Prevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of Gestational Diabetes Mellitus

    26 weeks gestation

Secondary Outcomes (9)

  • Changes in maternal levels of fasting glucose

    study entry, 16 weeks, 26 weeks gestation

  • Changes in maternal levels of fasting insulin

    study entry, 16 weeks, 26 weeks gestation

  • Changes in maternal levels of systolic and diastolic blood pressure

    study entry, 16 weeks, 26 weeks gestation

  • Changes in maternal levels of C-reactive protein

    study entry, 16 weeks, 26 weeks gestation

  • Incidence of preeclampsia

    Delivery

  • +4 more secondary outcomes

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Behavioral: Lifestyle intervention

Health Promotion

ACTIVE COMPARATOR

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

Other: Health Promotion

Interventions

Lifestyle interventionBEHAVIORAL

Intervention group will receive comprehensive behavioral weight loss program.

Lifestyle Intervention
Health PromotionOTHER

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

Health Promotion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Polytechnic State University

San Luis Obispo, California, 93401, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

  • 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. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8.

    PMID: 36758710DERIVED

  • 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.

    PMID: 33827659DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Suzanne Phelan, PhD

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 5, 2016

Study Start

December 15, 2017

Primary Completion

April 15, 2022

Study Completion

July 29, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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.

Locations

US(2)