NCT01600534

Brief Summary

This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

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

Study Start

First participant enrolled

May 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.8 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

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

May 15, 2012

Last Update Submit

September 10, 2014

Conditions

Keywords

gestational diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in glycosylated hemoglobin

    Baseline and 36 weeks gestation

Secondary Outcomes (1)

  • Change in weight after pregnancy

    6 weeks postpartum to 24 weeks postpartum

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Participants obtain access to an internet-based educational intervention.

Behavioral: lifestyle counseling

Usual Care Lifestyle counseling

OTHER

Self directed educational intervention

Behavioral: lifestyle counseling

Interventions

Participants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program.

Also known as: healthy lifestyle, glucose control
Lifestyle counselingUsual Care Lifestyle counseling

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with gestational diabetes
  • Planning to delivery with the study area

You may not qualify if:

  • Pre-existing diabetes (type 1 or type 2 diabetes)
  • Non-English speaking
  • Not planning to delivery in the study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina clinics

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.

    PMID: 17554614BACKGROUND
  • Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glycemic Control

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Wanda Nicholson, MD MPH MBA

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations