NCT04861324

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

April 22, 2021

Last Update Submit

February 16, 2023

Conditions

Gestational DiabetesType 2 DiabetesNutritional and Metabolic Disease

Outcome Measures

Primary Outcomes (4)

  • Maternal glycemic control

    Blood glycated hemoglobin

    12 weeks

  • Maternal gestational weight gain

    Body weight

    12 weeks

  • Maternal medication usage

    Glucose-lowering medications

    12 weeks

  • Maternal Lipids

    LDL-cholesterol and triglycerides

    12 weeks

Secondary Outcomes (2)

  • Maternal inflammation

    12 weeks

  • Maternal serum carotenoids

    12 weeks

Study Arms (2)

Prenatal Care/Nutrition Education

NO INTERVENTION

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

Fruit/veggie + postprandial physical activity

EXPERIMENTAL

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

Behavioral: Dietary Intervention

Interventions

Dietary InterventionBEHAVIORAL

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

Fruit/veggie + postprandial physical activity

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales going through pregnancy and diagnosed with gestational diabetes
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • carrying more than one fetus
  • history of chronic conditions except diabetes and hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNLV School of Medicine MFM clinic

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Metabolic Diseases

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Arpita Basu, PhD

    University of Nevada at Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

April 28, 2021

Primary Completion

December 31, 2022

Study Completion

January 30, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

US(1)