Trial record 19 of 1536 for:    Open Studies | "Body Weight"

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

This study is currently recruiting participants.
Verified March 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01768793
First received: January 11, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obesity
Pregnancy
Weight Gain
Behavioral: Standard Parents As Teachers (PAT)
Behavioral: Parents As Teachers Plus (PAT+)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight Management in Obese Pregnant Underserved African American Women

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations [ Time Frame: Delivery (when the baby is delivered) ] [ Designated as safety issue: No ]

Estimated Enrollment: 266
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
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).
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.

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). An extensive 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768793

Contacts
Contact: Carla Chung, RN, BSN (314) 362-4661 chungc@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Samuel Klein, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01768793     History of Changes
Other Study ID Numbers: 201110073, 5U01DK094416
Study First Received: January 11, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Obesity
Pregnancy
Body Weight Changes
Diet Therapy

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 15, 2014