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A Lifestyle Intervention to Prevent Gestational Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Association of Schools of Public Health
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT01141582
First received: May 12, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The overall goal of this project is to develop and evaluate a pilot lifestyle intervention to prevent the occurrence of Gestational Diabetes (GDM). GDM among pregnant, overweight Hispanic women at increased risk for GDM. A total of 66 women will be recruited and randomized in pregnancy to a lifestyle intervention or standard of care group. The lifestyle intervention will be a 6 month program consisting of monthly in-person educational sessions and biweekly telephone booster calls, which will continue until delivery.


Condition Intervention Phase
Gestational Diabetes
 Behavioral: Lifestyle Intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Estudio VIDA (Valoración e Intervención Dietética y de Actividad Física): A Pilot Lifestyle Intervention for Gestational Diabetes Among Hispanic Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • Baseline Glycemic Control [ Time Frame: Before 16 weeks GA ] [ Designated as safety issue: No ]
  • Mid-Pregnancy Glycemic Control [ Time Frame: 24-28 weeks GA ] [ Designated as safety issue: No ]
  • Postpartum Glycemic Control [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline Markers of Insulin Resistance [ Time Frame: Before 16 weeks GA ] [ Designated as safety issue: No ]
  • Mid-Pregnancy Markers of Insulin Resistance [ Time Frame: 24-28 weeks GA ] [ Designated as safety issue: No ]
  • Postpartum Markers of Insulin Resistance [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Baseline Blood Lipids [ Time Frame: Before 16 weeks GA ] [ Designated as safety issue: No ]
  • Mid-Pregnancy Blood Lipids [ Time Frame: 24-28 weeks GA ] [ Designated as safety issue: No ]
  • Postpartum Blood Lipids [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Birth Outcomes [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Baseline Blood Pressure [ Time Frame: Before 16 weeks GA ] [ Designated as safety issue: No ]
  • Mid-Pregnancy Blood Pressure [ Time Frame: 24-28 weeks GA ] [ Designated as safety issue: No ]
  • Postpartum Blood Pressure [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Baseline Maternal Weight [ Time Frame: Before 16 weeks GA ] [ Designated as safety issue: No ]
  • Mid-Pregnancy Weight [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]
  • Postpartum Maternal Weight [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention
Stage-matched physical activity and nutrition intervention.
 Behavioral: Lifestyle Intervention
Stage-matched physical activity and nutrition intervention.
No Intervention: Standard Care
Standard care.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hispanic, Puerto Rican and Dominican
  • Female
  • Pregnant
  • Overweight (BMI>25 kg/m2)

Exclusion Criteria:

  • Age <18 or >40 years
  • History of diagnosis of type 1 or 2 diabetes,
  • Hypertension, heart disease or chronic renal disease
  • Current medications which adversely influence glucose tolerance
  • Not planning to continue the pregnancy to term or deliver at the study site
  • >16 weeks gestation
  • Contraindications to participating in moderate physical activity or a low-fat/high-fiber diet (e.g., medical condition such as Crohn's disease, ulcerative colitis, end-stage renal disease)
  • Self-reported participation in >30 min of moderate or vigorous-intensity exercise on >3 days/wk
  • Prior participation in the study
  • Pregnant with twins or triplets.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141582

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Mercy Medical Center
Springfield, Massachusetts, United States, 01104
Sponsors and Collaborators
University of Massachusetts, Amherst
Association of Schools of Public Health
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Lisa Chasan-Taber, Sc.D. University of Massachusetts, Amherst
  More Information

No publications provided by University of Massachusetts, Amherst

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lisa Chasan-Taber, Associate Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT01141582     History of Changes
Obsolete Identifiers: NCT00728377
Other Study ID Numbers: ASPH S3948
Study First Received: May 12, 2010
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Amherst:
Gestational Diabetes, Lifestyle Intervention, Hispanics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013