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Completed

NCT Number: NCT01768793

Weight Management in Obese Pregnant Underserved African American Women

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Parents As Teachers (PAT)

Behavioral

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.

Parents As Teachers Plus (PAT+)

Behavioral

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.

Primary outcomes

  1. Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations

    Time frame: Delivery (when the baby is delivered)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: LIFE-Moms

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jan 15, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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