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NCT02763150 Clinical Trial

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

Gestational Diabetes Mellitus Clinical Trial

Official title:
Gestational Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02763150
Other study ID # CP-GDPP-trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date July 29, 2022

Study information
Verified date July 2022
Source California Polytechnic State University-San Luis Obispo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 199
Est. completion date July 29, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle intervention
Intervention group will receive comprehensive behavioral weight loss program.
Other:
• Health Promotion
The health promotion group will receive education on healthy eating and activity

Locations
Country Name City State
United States Miriam Hospital Providence Rhode Island
United States California Polytechnic State University San Luis Obispo California

Sponsors (2)
Lead Sponsor Collaborator
California Polytechnic State University-San Luis Obispo Brown University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Gestational Diabetes Mellitus 26 weeks gestation
Secondary Changes in maternal levels of fasting glucose study entry, 16 weeks, 26 weeks gestation
Secondary Changes in maternal levels of fasting insulin study entry, 16 weeks, 26 weeks gestation
Secondary Changes in maternal levels of systolic and diastolic blood pressure study entry, 16 weeks, 26 weeks gestation
Secondary Changes in maternal levels of C-reactive protein study entry, 16 weeks, 26 weeks gestation
Secondary Incidence of preeclampsia Delivery
Secondary Incidence of cesarean delivery Delivery
Secondary Weight changes study entry, 16 weeks, 26 weeks gestation
Secondary Daily caloric intake study entry, 16 weeks, 26 weeks gestation
Secondary Minutes per week of moderate physical activity study entry, 16 weeks, 26 weeks gestation
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