Effects of a Lifestyle Intervention on Gestational Diabetes Management

NCT ID: NCT04861324

Last Updated: 2023-02-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2023-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Type 2 Diabetes Nutritional and Metabolic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prenatal Care/Nutrition Education

Standard prenatal care with primary care physician with USDA-based federal guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Fruit/veggie + postprandial physical activity

Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type BEHAVIORAL

Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Intervention

Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* high risk for gestational diabetes
* willing to make lifestyle changes
* history of diabetes

Exclusion Criteria

* carrying more than one fetus
* history of chronic conditions except diabetes and hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Arpita Basu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arpita Basu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada at Las Vegas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UNLV School of Medicine MFM clinic

Las Vegas, Nevada, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1610677

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personalized Dietary Management in Type 2 Diabetes
NCT05046886 ACTIVE_NOT_RECRUITING NA