Trial record 16 of 118 for:    (hispanic OR latina) AND (woman OR women OR female)

Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Massachusetts, Amherst
Sponsor:
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT01868230
First received: May 29, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (~12 wks gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.


Condition Intervention
Diabetes
Behavioral: Lifestyle Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 24 weeks gestation ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 34 weeks gestation ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 333
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
Behavioral: Lifestyle Intervention
No Intervention: Health and Wellness
Standard of care.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hispanic women
  • Overweight or obese before pregnancy (BMI >25 kg/m2)
  • 16-45 years old

Exclusion Criteria:

  • history of type 2 diabetes, heart disease, or chronic renal disease
  • contraindications to participation in moderate physical activity or to a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
  • inability to read English or Spanish at a 6th grade level
  • >20 wks gestation
  • current medications which adversely influence glucose tolerance
  • not planning to continue to term or deliver at the study site
  • pregnant with twins or triplets
  • preterm birth (<34 wks), a miscarriage, or a still birth after enrollment or a stillbirth
  • women who become pregnant again in the year following delivery will be censored at the time of their positive pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868230

Contacts
Contact: Lisa Chasan-Taber, ScD 413-545-1664 lct@schoolph.umass.edu
Contact: Megan W Harvey, MS 413-545-6732 meward@schoolph.umass.edu

Locations
United States, Massachusetts
Baystate Medical Center Not yet recruiting
Springfield, Massachusetts, United States, 01199
Contact: Glenn Markenson, MD       Glenn.Markenson@baystatehealth.org   
Principal Investigator: Glenn Markenson, MD         
Sponsors and Collaborators
University of Massachusetts, Amherst
Investigators
Principal Investigator: Lisa Chasan-Taber, ScD University of Massachusetts, Amherst
  More Information

No publications provided

Responsible Party: Lisa Chasan-Taber, Professor of Epidemiology, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT01868230     History of Changes
Other Study ID Numbers: NIH R01 DK097011-01
Study First Received: May 29, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2014