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
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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COMPLETED
NA
199 participants
INTERVENTIONAL
2017-12-15
2022-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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.
Lifestyle intervention
Intervention group will receive comprehensive behavioral weight loss program.
Health Promotion
Health promotion group will receive education on healthy eating and activity before pregnancy.
Health Promotion
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.
Health Promotion
The health promotion group will receive education on healthy eating and activity
Eligibility Criteria
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Inclusion Criteria
* BMI \> 25 kg/m2
* Planning to have a baby in the next 1-3 years
* English or Spanish speaking
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Brown University
OTHER
California Polytechnic State University-San Luis Obispo
OTHER
Responsible Party
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Suzanne Phelan
Professor
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
Miriam Hospital
Providence, Rhode Island, United States
Countries
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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.
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.
Other Identifiers
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CP-GDPP-trial
Identifier Type: -
Identifier Source: org_study_id
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