A Lifestyle Intervention to Prevent Gestational Diabetes - Full Text View

Sponsor:	University of Massachusetts, Amherst
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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Postpartum Care

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:	June 2012
Estimated Primary Completion Date:	June 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):

Chasan-Taber L, Silveira M, Marcus BH, Braun B, Stanek E, Markenson G. Feasibility and efficacy of a physical activity intervention among pregnant women: the behaviors affecting baby and you (B.A.B.Y.) study. J Phys Act Health. 2011 Sep;8 Suppl 2:S228-38.

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:	May 1, 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 23, 2012