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Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868230
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 4, 2013
Last Update Posted Date December 16, 2020
Study Start Date  ICMJE June 2014
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • Insulin Resistance [ Time Frame: 10 weeks gestation ]
  • Insulin Resistance [ Time Frame: 24 weeks gestation ]
  • Insulin Resistance [ Time Frame: 34 weeks gestation ]
  • Insulin Resistance [ Time Frame: 6 weeks postpartum ]
  • Insulin Resistance [ Time Frame: 6 months postpartum ]
  • Insulin Resistance [ Time Frame: 12 months postpartum ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Official Title  ICMJE Proyecto Mama: Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE Behavioral: Lifestyle Intervention
Study Arms  ICMJE
  • Experimental: Lifestyle Intervention
    Stage-matched physical activity and diet intervention materials and health education.
    Intervention: Behavioral: Lifestyle Intervention
  • No Intervention: Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
232
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2013)
333
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868230
Other Study ID Numbers  ICMJE 1R01DK097011-01A1( U.S. NIH Grant/Contract )
1R01DK097011-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lisa Chasan-Taber, University of Massachusetts, Amherst
Study Sponsor  ICMJE University of Massachusetts, Amherst
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Lisa Chasan-Taber, ScD University of Massachusetts, Amherst
PRS Account University of Massachusetts, Amherst
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP