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

NCT ID: NCT02763150

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2022-07-29

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyle Intervention

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

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Intervention group will receive comprehensive behavioral weight loss program.

Health Promotion

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

Group Type ACTIVE_COMPARATOR

Health Promotion

Intervention Type OTHER

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

Interventions

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Lifestyle intervention

Intervention group will receive comprehensive behavioral weight loss program.

Intervention Type BEHAVIORAL

Health Promotion

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Phelan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Phelan, PhD

Role: PRINCIPAL_INVESTIGATOR

California Polytechnic State University-San Luis Obispo

Locations

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California Polytechnic State University

San Luis Obispo, California, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36758710 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33827659 (View on PubMed)

Other Identifiers

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CP-GDPP-trial

Identifier Type: -

Identifier Source: org_study_id

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