Weight Management in Obese Pregnant Underserved African American Women

Obesity Clinical Trial

— LIFE-Moms  

Official title:

Weight Management in Obese Pregnant Underserved African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768793
• Other study ID #: 201110073
• Secondary ID: 5U01DK094416
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: February 1, 2018
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Pregnancy
• Weight Gain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations		Delivery (when the baby is delivered)

External Links

•   Study Consortium website