NCT01719406

Brief Summary

Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a condition that can adversely affect the pregnant woman, her developing fetus and future events for both. To reduce GDM risk, we will develop and implement an in-person team and web-based nutrition and exercise program for women, beginning in their first trimester. A scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams (5 women/team), will be developed and implemented among pregnant employees and/or their spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate daily physical activity with nutrition targets of five servings of fruits and vegetables, 3 servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will occur before enrollment during the first trimester, each subsequent trimester and 12 weeks after delivery. In addition to exercise and diet survey results, we will assess fasting glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12 weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant birth weight, and weekly health thermometer self-ratings during the assessment period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

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

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

October 29, 2012

Last Update Submit

October 14, 2014

Conditions

Gestational Diabetes

Keywords

Gestational diabetesExerciseDietFruitsVegetablesWhole grainspregnancy weight

Outcome Measures

Primary Outcomes (1)

  • Achieving 30 minutes of daily exercise, four or more times each week

    Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.

    32 weeks

Secondary Outcomes (1)

  • Eating 5 or more servings of vegetables and/or fruits each day

    32 weeks of the study

Other Outcomes (2)

  • Pregnancy weight gain

    20 weeks

  • HemoglobinA1C

    Each trimester and 12-weeks post delivery

Study Arms (2)

Intervention, behavioral lifestyle education

EXPERIMENTAL

Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.

Behavioral: Intervention, behavioral lifestyle education

Control

NO INTERVENTION

Standard medical care

Interventions

Intervention, behavioral lifestyle educationBEHAVIORAL

Twenty interactive weekly sessions that are scripted curriculum and peer led.

Also known as: Lifestyle, Nutrition, Exercise, Stress management
Intervention, behavioral lifestyle education

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalMotor Activity

Interventions

MethodsNutritional StatusExercise

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 15, 2014

Record last verified: 2013-01

Locations

US(1)