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Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms)

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ClinicalTrials.gov Identifier: NCT01768793
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 11, 2013
First Posted Date  ICMJE January 15, 2013
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations [ Time Frame: Delivery (when the baby is delivered) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2013)
Gestational weight gain meeting Institute of Medicine recommendations [ Time Frame: Delivery (when the baby is delivered) ]
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 Weight Management in Obese Pregnant Underserved African American Women
Official Title  ICMJE Weight Management in Obese Pregnant Underserved African American Women
Brief Summary This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.
Detailed Description Maternal overweight/obesity and inappropriate gestational weight gain increase both maternal and neonatal morbidity and mortality. In addition, offspring of overweight/obese women are at increased risk for neurodevelopmental delay, becoming obese, and developing metabolic diseases. Women who are socioeconomically disadvantaged (SED), especially from African American populations, are particularly susceptible to adverse pregnancy-related outcomes because of their high prevalence rates of obesity. Therefore, successful weight management during pregnancy in SED, African American women has considerable public health implications. We have experience in testing lifestyle interventions among SED nonpregnant women that have been implemented and sustained within community organizations such as Parents As Teachers (PAT), a national home visiting program that provides parent-child education and services free-of-charge to high-needs women, prenatally and post-partum, with up to 25 home visits per year until kindergarten. We propose to conduct a 24-month (6-month prenatal and 18-month post-partum) randomized, controlled trial in overweight and obese SED African American women to evaluate the ability of an innovative lifestyle intervention program (PAT+), delivered by PAT parent educators during prenatal and post-partum home visits, to improve maternal and neonatal/infant weight, metabolic and health outcomes, relative to the standard PAT program (PAT). A programmatic evaluation will determine the applicability of the PAT+ intervention in real world settings by measuring programmatic reach, implementation, acceptability, and sustainability. If effective, PAT+ can be disseminated through this national organization, which currently reaches over 249,000 mothers and 319,000 children participating in 2,173 PAT programs across all 50 states.
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
  • Obesity
  • Pregnancy
  • Weight Gain
Intervention  ICMJE
  • Behavioral: Standard Parents As Teachers (PAT)
    Participants will receive visits by Parent Educators, who will deliver the standard PAT curriculum. Participants will receive 28 total visits over the course of approximately 2 years.
  • Behavioral: Parents As Teachers Plus (PAT+)
    Participants will receive the standard PAT curriculum, plus lifestyle intervention focusing on healthy diet and exercise, through 28 home visits over the course of approximately 2 years.
Study Arms  ICMJE
  • Experimental: Parents As Teachers + Lifestyle Int.
    Participants assigned to this group will receive Parents As Teachers Plus (PAT+). This will be a diet and physical activity lifestyle intervention integrated within the standard Parents As Teachers home visiting curriculum. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).
    Intervention: Behavioral: Parents As Teachers Plus (PAT+)
  • Active Comparator: Standard Parents as Teachers (PAT)
    Participants assigned to this group will receive the standard Parents As Teachers (PAT) home visiting curriculum, focusing on parenting and child development. There will be a total of 28 home visits, delivered over 24 months (6 month prenatal phase and 18 month post-partum phase).
    Intervention: Behavioral: Standard Parents As Teachers (PAT)
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: March 16, 2016)
267
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2013)
266
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant, African American, Socioeconomically disadvantaged
  • Established prenatal care at our clinic before 15-6/7 weeks gestation
  • Singleton viable pregnancy
  • Gestational age 9 to 15 weeks
  • Body Mass Index (BMI) of 25-45 kg/m²

Exclusion Criteria:

  • Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes
  • Current use of certain medications
  • Contraindications to aerobic exercise in pregnancy
  • History of contraindicated medical conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01768793
Other Study ID Numbers  ICMJE 201110073
5U01DK094416 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2018

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