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

The Washington University

Status: Completed

Conditions: Weight Gain; Obesity; Pregnancy

Treatments: Behavioral: Standard Parents As Teachers (PAT); Behavioral: Parents As Teachers Plus (PAT+)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01768793

5U01DK094416 (U.S. NIH Grant/Contract)

201110073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

267 participants in 2 patient groups

Parents As Teachers + Lifestyle Int.

Experimental group

Description:

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).

Treatment:

Behavioral: Parents As Teachers Plus (PAT+)

Standard Parents as Teachers (PAT)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard Parents As Teachers (PAT)